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1.
Ophthalmology ; 131(9): 1021-1032, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38423216

RESUMO

PURPOSE: To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of 2 models of the travoprost intraocular implant (fast-eluting [FE] and slow-eluting [SE] types) from 1 of 2 phase 3 trials (the GC-010 trial). DESIGN: Multicenter, randomized, double-masked, sham-controlled, noninferiority trial. PARTICIPANTS: Patients with open-angle glaucoma or ocular hypertension having an unmedicated baseline mean diurnal IOP (average of 8 am, 10 am, and 4 pm time points) of ≥ 21 mmHg, and IOP of ≤ 36 mmHg at each of the 8 am, 10 am, and 4 pm timepoints at baseline. METHODS: Study eyes were randomized to the travoprost intraocular implant (FE implant [n = 200] or SE implant [n = 197] model) or to timolol ophthalmic solution 0.5% twice daily (n = 193). MAIN OUTCOME MEASURES: The primary outcome was mean change from baseline IOP in the study eye at 8 am and 10 am, at each of day 10, week 6, and month 3. Safety outcomes included adverse events (AEs) and ophthalmic assessments. RESULTS: Mean IOP reduction from baseline over the 6 time points ranged from 6.6 to 8.4 mmHg for the FE implant group, from 6.6 to 8.5 mmHg for the SE implant group, and from 6.5 to 7.7 mmHg for the timolol group. The primary efficacy end point was met; the upper limit of the 95% confidence interval of the difference between the implant groups and the timolol group was < 1 mmHg at all 6 time points. Study eye AEs, most of mild or moderate severity, were reported in 21.5%, 27.2%, and 10.8% of patients in the FE implant, SE implant, and timolol groups, respectively. The most common AEs included iritis (FE implant, 0.5%; SE implant, 5.1%), ocular hyperemia (FE implant, 3.0%; SE implant, 2.6%), reduced visual acuity (FE implant, 1.0%; SE implant, 4.1%; timolol, 0.5%), and IOP increased (FE implant, 3.5%; SE implant, 2.6%; timolol, 2.1%). One serious study eye AE occurred (endophthalmitis). CONCLUSIONS: The travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period after a single administration. The IOP-lowering efficacy in both implant groups was statistically and clinically noninferior to that in the timolol group, with a favorable safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.


Assuntos
Anti-Hipertensivos , Implantes de Medicamento , Glaucoma de Ângulo Aberto , Pressão Intraocular , Hipertensão Ocular , Tonometria Ocular , Travoprost , Humanos , Glaucoma de Ângulo Aberto/tratamento farmacológico , Glaucoma de Ângulo Aberto/fisiopatologia , Pressão Intraocular/efeitos dos fármacos , Pressão Intraocular/fisiologia , Hipertensão Ocular/tratamento farmacológico , Hipertensão Ocular/fisiopatologia , Travoprost/uso terapêutico , Travoprost/administração & dosagem , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Feminino , Masculino , Método Duplo-Cego , Idoso , Pessoa de Meia-Idade , Resultado do Tratamento , Acuidade Visual/fisiologia , Timolol/administração & dosagem , Timolol/uso terapêutico , Timolol/efeitos adversos , Soluções Oftálmicas , Idoso de 80 Anos ou mais , Adulto
2.
Exp Eye Res ; 191: 107928, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31926968

RESUMO

Glaucoma is a major cause of blindness, and IOP reduction remains the only clinically-validated therapy. In this study, we analyze a novel IOP-lowering strategy that uses a modest negative pressure (vacuum) applied locally to the periorbital region by a pair of goggles with each lens individually connected to a programmable pump. Motivated by clinical data showing an IOP reduction, we used an existing validated lumped-parameter model of the eye to understand the putative mechanism of this treatment. The model considers aqueous humor dynamics, episcleral venous pressure, and changes in ocular blood volume to describe how IOP changes with time in response to an external perturbation. We find that clinical data are qualitatively and quantitatively consistent with model predictions if we include two primary mechanisms in the model: first, negative pressure application causes a relatively rapid increase in globe volume accompanied by increased blood volume in the eye. Second, negative pressure application reduces episcleral venous pressure, causing a slower adjustment of IOP due to altered aqueous humor dynamics. These results provide testable hypotheses that hopefully will lead to a fuller experimentally-driven understanding of how negative periocular pressure influences IOP. Evaluating the long-term effects of such treatments on glaucoma patients requires further clinical study.


Assuntos
Humor Aquoso/fisiologia , Volume Sanguíneo/fisiologia , Descompressão , Pressão Intraocular/fisiologia , Esclera/irrigação sanguínea , Pressão Venosa/fisiologia , Humanos , Modelos Teóricos
3.
Clin Exp Ophthalmol ; 48(1): 37-43, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31503396

RESUMO

IMPORTANCE: Use of the trabecular micro-bypass stent with cataract surgery is well established to be safe and effective in primary open-angle glaucoma. This is the first study to exclusively evaluate use of the device in pigmentary glaucoma. BACKGROUND: This study aimed to investigate the safety and efficacy of a trabecular micro-bypass stent in combination with cataract surgery in pigmentary glaucoma. DESIGN: Retrospective, consecutive case series. PARTICIPANTS: Twenty-four eyes of 12 patients with pigmentary glaucoma implanted with one trabecular micro-bypass stent with concomitant cataract surgery. METHODS: Baseline data was collected and compared to the following postoperative time points: 1 day, 1 week, 1 month out to 36 months (M36) after the procedure. MAIN OUTCOME MEASURES: These included intraocular pressure (IOP), number of glaucoma medications and need for additional surgery. RESULTS: At M36 there was a 25% reduction in IOP to 14.68 ± 3.0 (P < .01) from 19.50 ± 6.7 mmHg at baseline. The mean number of glaucoma medications was 0.75 ± 1.0 prior to the surgery and 0.59 ± 0.6 (P > .05) at 36 M. At the 36 M time-point, 95% of eyes had IOP ≤ 18 mmHg and 68% of eyes were ≤ 15 mmHg. No eyes underwent a secondary glaucoma procedure. CONCLUSIONS AND RELEVANCE: The insertion of a single trabecular micro-bypass stent in combination with cataract surgery effectively provides a sustained reduction in IOP up to 3 years after surgery in patients with pigmentary glaucoma. The safety profile is favourable with low rate of IOP spikes and no patients requiring additional surgery.


Assuntos
Implantes para Drenagem de Glaucoma , Glaucoma de Ângulo Aberto/cirurgia , Facoemulsificação , Implantação de Prótese , Stents , Malha Trabecular/cirurgia , Idoso , Anti-Hipertensivos/administração & dosagem , Feminino , Glaucoma de Ângulo Aberto/fisiopatologia , Gonioscopia , Humanos , Pressão Intraocular/fisiologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tonometria Ocular , Acuidade Visual/fisiologia
4.
Ophthalmology ; 123(2): 265-274, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26707416

RESUMO

PURPOSE: To compare the anterior lens capsulotomy edge tear strength created by manual continuous curvilinear capsulorhexis (CCC), femtosecond laser capsulotomy (FSLC), and a new automated precision pulse capsulotomy (PPC) device. DESIGN: A 3-arm study in paired human cadaver eyes. PARTICIPANTS: A total of 44 eye specimens from 22 donors in the United States. METHODS: Capsulotomy was performed in all eye specimens using manual CCC, a femtosecond laser (LenSx, Alcon, Fort Worth, TX), or an automated PPC device (Zepto, Mynosys Inc., Fremont, CA). The first study arm consisted of 8 pairs of eyes in which 1 eye received PPC and the fellow eye received FSLC. The second study arm consisted of 8 pairs of eyes, with 1 eye receiving PPC and the fellow eye receiving manual CCC. The third study arm consisted of 6 pairs of eyes, with 1 eye receiving a manual CCC and the fellow eye receiving FSLC. After phacoemulsification, 2 capsulotomy edge retractors attached to force transducers were used to stretch the capsulotomy edge of each eye and to measure the resisting force until the capsulotomy edge was torn. MAIN OUTCOME MEASURES: Capsulotomy edge tear strength in millinewtons. RESULTS: The PPC edge tear strength was greater than that of FSLC for all 8 pairs of eyes by an average factor of 3.1-fold (PPC mean 73.3±24.9 mN vs. femtosecond laser mean 26.1±6.8 mN; P = 0.012, Wilcoxon matched-pairs, signed-ranks test). The PPC tear strength was greater than that of manual CCC for all 8 pairs of eyes by an average factor of 4.1-fold (PPC mean 95±35.2 mN vs. manual CCC mean 29.1±23.1 mN; P = 0.012, Wilcoxon matched-pairs signed-ranks test). There was no significant difference in the tear strength of capsulotomies produced by manual CCC (mean 21.3±4.9 mN) and FSLC (mean 24.5±11.4 mN) (P = 0.75, Wilcoxon matched-pairs signed-ranks test). CONCLUSIONS: The strength of the PPC capsulotomy edge was significantly stronger than that produced by femtosecond laser or manual CCC.


Assuntos
Cápsula Anterior do Cristalino/cirurgia , Capsulorrexe/métodos , Elasticidade/fisiologia , Terapia a Laser/métodos , Resistência à Tração/fisiologia , Idoso , Cápsula Anterior do Cristalino/fisiologia , Feminino , Humanos , Terapia a Laser/instrumentação , Masculino , Pessoa de Meia-Idade , Facoemulsificação , Doadores de Tecidos
5.
Curr Opin Ophthalmol ; 25(1): 62-70, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24310375

RESUMO

PURPOSE OF REVIEW: Refractive Laser Assisted Cataract Surgery (ReLACS) combines the femtosecond laser with other noncovered tests and services in an attempt to reduce spectacle dependence in combination with cataract surgery. Significant interest is present among ophthalmologists who are considering adopting this technology, however significant capital outlays and continuing expenses can make the decision to adopt ReLACS foreboding. We review the financial considerations of ReLACS and review the trends seen in early adopters of this technology. RECENT FINDINGS: Recent findings have shown that ReLACS is a growing segment of cataract surgery. Most practices who have implemented the technology have broken even and have a positive outlook on the financial return of implementing the ReLACS program. The average break-even analysis point for practices is around 230 cases a year. SUMMARY: ReLACS is growing and appears to be a financial viable approach for many practices.


Assuntos
Extração de Catarata/economia , Terapia a Laser/economia , Administração da Prática Médica/organização & administração , Extração de Catarata/métodos , Honorários e Preços , Humanos , Terapia a Laser/métodos , Consultórios Médicos/economia , Administração da Prática Médica/economia
6.
J Cataract Refract Surg ; 50(5): 481-485, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38192061

RESUMO

PURPOSE: To evaluate the sensitivity and specificity of swept-source optical coherence tomography (SS-OCT) biometer compared with the gold standard spectral-domain optical coherence tomography (SD-OCT) for detecting macular pathology in patients with cataract. SETTING: Eye Centers of Tennessee, Crossville, TN. DESIGN: Prospective, cross-sectional, observational, examiner-masked. METHODS: The study included 132 participants aged 50 years and older, who underwent precataract surgery work-up. All participants underwent fixation check retinal scans using SS-OCT biometer (IOLMaster 700) as well as full macular scans using Cirrus SD-OCT. 3 independent masked examiners evaluated the scans if they were normal or had a suspected pathology. Different measures of diagnostic accuracy were calculated for 3 examiners. RESULTS: True positive rate (sensitivity) ranged from 71.1% (32/45) to 79.2% (42/53), and false negative rate was between 20.8% (11/53) and 28.9% (13/45) for the 3 examiners. True negative rate (specificity) ranged from 86.8% (59/68) to 94.1% (64/68), and false positive rate was between 5.9 (4/68) and 13.2% (9/68). The fitted receiver operating characteristic area ranged from 0.83 to 0.95. CONCLUSIONS: Using retinal SS-OCT biometer scans as a replacement of the dedicated macular SD-OCT for screening or diagnosing macular health would not be appropriate because of its low sensitivity. SS-OCT biometer may potentially fail to identify approximately one-fourth of patients who actually have the disease. Therefore, the final decision on macular health should be based on the gold standard SD-OCT scans. When full macular SD-OCT scans are not accessible, the limited retinal scan information from SS-OCT biometer may still provide useful insights into the macular health.


Assuntos
Doenças Retinianas , Sensibilidade e Especificidade , Tomografia de Coerência Óptica , Humanos , Tomografia de Coerência Óptica/métodos , Estudos Prospectivos , Estudos Transversais , Pessoa de Meia-Idade , Idoso , Feminino , Masculino , Doenças Retinianas/diagnóstico , Reações Falso-Positivas , Idoso de 80 Anos ou mais , Catarata/diagnóstico , Macula Lutea/patologia , Macula Lutea/diagnóstico por imagem , Reações Falso-Negativas , Reprodutibilidade dos Testes
7.
J Curr Glaucoma Pract ; 18(2): 63-67, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39144729

RESUMO

Aim and background: To compare the safety and efficacy of subconjunctival gel stent implantation in the superonasal (SN) vs inferonasal (IN) quadrants in the treatment of glaucoma. Materials and methods: Patients with a history of IN (n = 29) or SN, (n = 96) gel stent placement with ≥3 months of follow-up were included. Intraocular pressure (IOP) and the number of glaucoma medications were collected preoperatively and postoperatively at months 1, 3, 6, and 12. Safety measures included the number of bleb needlings, complication rate, and additional surgeries. Results: Mean baseline IOP was 32.4 ± 11.7 mm Hg in the IN group and 21.6 ± 9.2 mm Hg in the SN group (p < 0.01). IOP was similar between groups at 3 months (IN = 15.8, SN = 15.6, p = 0.45), 6 months (IN = 17.4, SN = 15, p = 0.13), and 12 months (IN = 17.9, SN = 14.7, p = 0.15) follow-up. The number of glaucoma medications was also similar at 3 months (p = 0.31), 6 months (p = 0.24), and 12 months (p = 0.39) follow-up. Bleb needling rates were similar with 51.7% (15/29) in the IN group vs 42.7% (41/96) in the SN group (p = 0.39) and subjects requiring further surgery were 17.2% (5/29) in the IN group vs 24.0% (23/96) in the SN group (p = 0.45). Conclusion: Both IN and SN subconjunctival gel stent placements provide favorable safety and efficacy when treating open-angle glaucoma, with a meaningful decrease in medication use and IOP. Clinical significance: Implantation of the subconjunctival gel stent in the IN quadrant is an effective and safe alternative to superior implantation in refractory glaucoma. How to cite this article: Vander Zee BL, Wilson C, Berdahl JP, et al. Superonasal vs Inferonasal Subconjunctival Gel Stent Placement in Patients with Glaucoma. J Curr Glaucoma Pract 2024;18(2):63-67.

8.
J Cataract Refract Surg ; 50(9): 936-941, 2024 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-38736178

RESUMO

PURPOSE: To evaluate the visual and refractive outcomes in eyes with a history of laser corneal refractive surgery implanted with the second-generation light-adjustable lens (LAL). SETTING: Private practice, Sioux Falls, South Dakota. DESIGN: Retrospective, consecutive case series. METHODS: Eyes with a history of prior corneal refractive surgery that underwent cataract surgery with implantation of the LAL and were targeted for plano were included. Data on the type and number of prior refractive surgeries were collected, in addition to the timing and number of postoperative adjustments. The primary outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity, and the percentage (%) of eyes within ±0.25 diopter (D), ±0.50 D, and ±1.00 D of their refractive target. RESULTS: 76 eyes from 70 patients were included. A total of 45 eyes with a history of 1 prior refractive surgery and 31 eyes with a history of ≥2 refractive surgeries were included. 74% (n = 56) of all eyes achieved UDVA of 20/20 or better, 88% (n = 67) achieved 20/25 UDVA or better, and 93% (n = 71) were correctable to 20/20 or better postoperatively. For refractive outcomes, 66% of eyes (n = 50) were within ±0.25 D and 86% (n = 65) were within ±0.50 D of refractive target. CONCLUSIONS: Patients with a history of laser corneal refractive surgery achieved favorable visual and refractive outcomes with the LAL. This intraocular lens (IOL), which affords postoperative adjustability, is a promising option for patients with a history of corneal refractive surgery who maintain high expectations for functional uncorrected acuity after cataract surgery.


Assuntos
Implante de Lente Intraocular , Lentes Intraoculares , Refração Ocular , Acuidade Visual , Humanos , Acuidade Visual/fisiologia , Estudos Retrospectivos , Refração Ocular/fisiologia , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Facoemulsificação , Ceratomileuse Assistida por Excimer Laser In Situ/métodos , Cirurgia da Córnea a Laser/métodos , Adulto , Pseudofacia/fisiopatologia , Lasers de Excimer/uso terapêutico , Desenho de Prótese
9.
Drugs ; 84(1): 83-97, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38060092

RESUMO

PURPOSE: A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication. METHODS: Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% (n = 49). IOP was measured at baseline, day 1-2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters. RESULTS: Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint (P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months. CONCLUSION: The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months. TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.


Assuntos
Glaucoma de Ângulo Aberto , Glaucoma , Hipertensão Ocular , Humanos , Travoprost/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Glaucoma de Ângulo Aberto/cirurgia , Pressão Intraocular , Timolol/efeitos adversos , Anti-Hipertensivos/efeitos adversos , Cloprostenol/efeitos adversos , Hipertensão Ocular/tratamento farmacológico , Glaucoma/tratamento farmacológico , Soluções Oftálmicas/uso terapêutico , Método Duplo-Cego , Resultado do Tratamento
10.
Drugs ; 84(10): 1299-1311, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-39240530

RESUMO

AIM: The purpose of this study was to conduct and interpret a pooled 12-month analysis of two prospective, multi-center, randomized, double-masked, controlled trials designed to assess the efficacy and safety of the travoprost intracameral implant (slow-eluting [SE] implant in development as a new therapeutic and fast-eluting [FE] implant included for masking purposes) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: Subjects with OAG or OHT, on 0-3 intraocular pressure (IOP)-lowering medications, baseline unmedicated mean diurnal IOP of ≥ 21 mmHg, and IOP ≤ 36 mmHg at each baseline diurnal timepoint, received either a travoprost implant and twice-daily (BID) placebo eye drops or BID timolol 0.5% eye drops and a sham procedure. Subjects were followed through 12 months and assessed for IOP, reduction in topical IOP-lowering medications, and safety parameters including treatment-emergent adverse events (TEAEs). IOP at 8AM was prospectively collected at all study visits through 12 months and diurnal IOP, measured at 8AM, 10AM, and 4PM, was prospectively collected at baseline, day 10, week 6, and months 3 and 12. RESULTS: A total of 1150 subjects were randomized (385 FE implant, 380 SE implant, and 385 sham/timolol) across the two trials. Statistical non-inferiority to timolol and clinically relevant reductions in 8AM IOPs were demonstrated at month 12. In more detail, both implant groups demonstrated statistical non-inferiority to timolol and clinically relevant reductions from baseline in mean diurnal IOP at all visits over the 12-month evaluation period when diurnal IOP was collected. Additionally, both implant groups demonstrated robust treatment effect based on 8AM average IOP from day 10 through the specified visit which ranged from day 10 to month 12 from 6.9 to 8.5 mmHg in the FE implant group; 6.8 to 8.5 mmHg in the SE implant group; and 7.3 to 7.5 mmHg in the sham/timolol group. With regards to reduction in topical pharmacotherapy, at month 12, 77.6% of FE and 81.4% of SE implant eyes were completely free of all topical IOP-lowering medications and a significantly greater proportion of FE and SE implant eyes (89.9% and 93.0%) versus sham/timolol eyes (66.9%) were on the same or fewer topical IOP-lowering medications compared with pre-study (p <  0.0001). Furthermore, of subjects on topical IOP medications at screening, a significantly greater proportion of FE implant (80.2%) and SE implant (85.1%) eyes versus sham/timolol (22.8%) eyes were on fewer topical IOP-lowering medications at month 12 compared with pre-study (p <  0.0001). Lastly, of SE implant eyes on same or fewer topical IOP-lowering medications at month 12, the average through month 12 decreased by 0.9 medications, and of those SE implant eyes on fewer topical IOP-lowering medications compared with pre-study, the average through month 12 decreased by 1.4 medications. The most common TEAEs related to study treatment were hyperemia (conjunctival or ocular), iritis, and IOP increased. CONCLUSION: The travoprost intracameral implant demonstrated robust IOP-lowering efficacy that was sustained and statistically non-inferior to timolol over the entire 12 months, resulting in a significant reduction in topical IOP-lowering medication use, with the majority of SE implant eyes remaining completely free of all topical IOP-lowering medications. In addition, the implant demonstrated a favorable safety and tolerability profile based on this pooled 12-month analysis of two pivotal trials. TRIAL REGISTRATION: ClinicalTrials.gov identifiers NCT03519386 (registered May 09, 2018) and NCT03868124 (registered March 08, 2019).


Assuntos
Anti-Hipertensivos , Glaucoma de Ângulo Aberto , Pressão Intraocular , Hipertensão Ocular , Travoprost , Humanos , Travoprost/administração & dosagem , Travoprost/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Pressão Intraocular/efeitos dos fármacos , Hipertensão Ocular/tratamento farmacológico , Feminino , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/farmacologia , Masculino , Pessoa de Meia-Idade , Idoso , Método Duplo-Cego , Estudos Prospectivos , Timolol/administração & dosagem , Timolol/efeitos adversos , Timolol/uso terapêutico , Implantes de Medicamento , Resultado do Tratamento , Soluções Oftálmicas/administração & dosagem , Soluções Oftálmicas/uso terapêutico , Adulto
11.
Ophthalmol Ther ; 13(4): 995-1014, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38345710

RESUMO

INTRODUCTION: This prospective, multicenter, randomized, double-masked pivotal phase 3 trial evaluated the efficacy and safety of the travoprost intracameral SE-implant (slow-eluting implant, the intended commercial product) and FE-implant (fast-eluting implant, included primarily for masking purposes) compared to twice-daily (BID) timolol ophthalmic solution, 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: The trial enrolled adult patients with OAG or OHT with an unmedicated mean diurnal intraocular pressure (IOP) of ≥ 21 and unmedicated IOP ≤ 36 mmHg at each diurnal timepoint (8 A.M., 10 A.M., and 4 P.M.) at baseline. The eligible eye of each patient was administered an SE-implant, an FE-implant or had a sham administration procedure. Patients who received an implant were provided placebo eye drops to be administered BID and patients who had the sham procedure were provided timolol eye drops to be administered BID. The primary efficacy endpoint, for which the study was powered, was mean change from baseline IOP at 8 A.M. and 10 A.M. at day 10, week 6, and month 3. Non-inferiority was achieved if the upper 95% confidence interval (CI) on the difference in IOP change from baseline (implant minus timolol) was < 1.5 mmHg at all six timepoints and < 1 mmHg at three or more timepoints. The key secondary endpoint was mean change from baseline IOP at 8 A.M. and 10 A.M. at month 12. Non-inferiority at month 12 was achieved if the upper 95% CI was < 1.5 mmHg at both timepoints. Safety outcomes included treatment-emergent adverse events (TEAEs) and ophthalmic assessments. RESULTS: A total of 590 patients were enrolled at 45 sites and randomized to one of three treatment groups: 197 SE-implant (the intended commercial product), 200 FE-implant, and 193 timolol. The SE-implant was non-inferior to timolol eye drops in IOP lowering over the first 3 months, and was also non-inferior to timolol at months 6, 9, and 12. The FE-implant was non-inferior to timolol over the first 3 months, and also at months 6 and 9. Of those patients who were on glaucoma medication at screening, a significantly greater proportion of patients in the SE- and FE-implant groups (83.5% and 78.7%, respectively) compared to the timolol group (23.9%) were on fewer topical glaucoma medications at month 12 compared to screening (P < 0.0001, chi-square test). TEAEs, mostly mild, were reported in the study eyes of 39.5% of patients in the SE-implant group, 34.0% of patients in the FE-implant group and 20.1% of patients in the timolol group. CONCLUSIONS: The SE-travoprost intracameral implant demonstrated non-inferiority to timolol over 12 months whereas the FE-implant demonstrated non-inferiority over 9 months. Both implant models were safe and effective in IOP lowering in patients with OAG or OHT. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03519386.

12.
Clin Ophthalmol ; 17: 2449-2457, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37614847

RESUMO

Purpose: To evaluate the clinical rationale of wavefront-shaping technology, describe how intraocular lenses (IOLs) using wavefront-shaping technology are differentiated from refractive or diffractive optical presbyopia-correcting designs, and describe the mode of action of this technology. Methods: Extended depth of focus (EDoF) IOLs are the latest class of presbyopia-correcting IOLs addressing the growing demand of patients for reduced spectacle dependence. These use various optical technologies, including diffractive designs (eg, TECNIS Symfony ZXR00 and AT LARA 29 MP) and non-diffractive designs such as small aperture (eg, IC-8 IOL and XtraFocus Pinhole Implant), spherical aberration (eg, MINI WELL Ready and LuxSmart), and wavefront shaping (eg, AcrySof IQ Vivity DFT015 and Clareon Vivity CNWET0). Despite some improvement in visual acuity at intermediate and near distances, these technologies can still be associated with increased rate of visual disturbances or poorer distance vision compared with monofocal IOLs. One way to overcome such limitations is using a wavefront-shaping optical principle. Results: Clinical data show that wavefront-shaping technology results in a continuous EDoF compared with a monofocal IOL while exhibiting a minimal halo, similar to an aspheric monofocal IOL. Clinically, this translates to a lens that has proven to exceed the American National Standards Institute/American Academy of Ophthalmology criteria for an EDoF IOL. Conclusion: The novel wavefront-shaping optic technology allows patients to achieve a continuous range of vision from distance to functional near with low levels of visual disturbances comparable with aspheric monofocal IOLs.

13.
Transl Vis Sci Technol ; 12(2): 5, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36745441

RESUMO

Purpose: The purpose of this study was to evaluate the effects of negative periocular pressure (NPP), and concomitant intraocular pressure (IOP) lowering, on the biomechanics of the optic nerve head (ONH) and cornea. Methods: We developed a validated finite element (FE) model of the eye to compute tissue biomechanical strains induced in response to NPP delivered using the Multi-Pressure Dial (MPD) system. The model was informed by clinical measurements of IOP lowering and was based on published tissue properties. We also conducted sensitivity analyses by changing pressure loads and tissue properties. Results: Application of -7.9 mmHg NPP decreased strain magnitudes in the ONH by c. 50% whereas increasing corneal strain magnitudes by c. 25%. Comparatively, a similar increase in corneal strain was predicted to occur due to an increase in IOP of 4 mmHg. Sensitivity studies indicated that NPP lowers strain in the ONH by reducing IOP and that these effects persisted over a range of tissue stiffnesses and spatial distributions of NPP. Conclusions: NPP is predicted to considerably decrease ONH strain magnitudes. It also increases corneal strain but to an extent expected to be clinically insignificant. Thus, using NPP to lower IOP and hence decrease ONH mechanical strain is likely biomechanically beneficial for patients with glaucoma. Translational Relevance: This study provides the first description of how NPP affects ONH biomechanics and explains the underlying mechanism of ONH strain reduction. It complements current empirical knowledge about the MPD system and guides future studies of NPP as a treatment for glaucoma.


Assuntos
Glaucoma , Disco Óptico , Humanos , Fenômenos Biomecânicos , Análise de Elementos Finitos , Simulação por Computador , Córnea
14.
Clin Ophthalmol ; 17: 861-868, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36945324

RESUMO

Purpose: To evaluate the clinical outcomes of a non-diffractive, wavefront-shaping extended depth-of-focus (EDOF) intraocular lens (IOL) in eyes with mild open-angle glaucoma (OAG). Setting: Private practice; Sioux Falls, South Dakota. Design: Prospective, open-label, interventional study. Methods: In total, 52 eyes of 26 patients with mild OAG were enrolled and completed the study. All patients were bilaterally implanted with a non-diffractive, wavefront-shaping EDOF IOL. Seventy-seven percent of the patients were implanted with a trabecular microbypass stent at the time of surgery. Primary outcome measures included binocular corrected and uncorrected distance visual acuity (CDVA and UDVA), uncorrected intermediate and near visual acuity (UIVA and UNVA) and contrast sensitivity as measured by a Pelli-Robson chart. A subjective questionnaire was also administered to patients. Results: At 4 months postoperative, the mean binocular UDVA and CDVA was 0.03 ± 0.12 and -0.06 ± 0.07, respectively. The mean UIVA and UNVA were 0.18 ± 0.12 and 0.31 ± 0.18, respectively. Eighty-five percent of the subjects achieved ≥20/25 UDVA and 77% of the subjects achieved ≥20/32 UIVA at 4 months postoperative. The mean binocular mesopic contrast sensitivity was 1.76 ± 0.16 at a spatial frequency of 1 cycle-per-degree (cpd). Eighty-five percent of the subjects reported they would choose the same lens and 1 subject reported they would choose a different IOL if it meant reduced spectacle independence. Conclusion: The non-diffractive, wavefront-shaping EDOF IOL can be safely implanted in eyes with mild, pre-perimetric open-angle glaucoma with favorable uncorrected distance and intermediate visual acuity. The contrast sensitivity measurements were favorable and the subjective questionnaire revealed satisfactory spectacle independence and patient satisfaction.

15.
Ther Adv Ophthalmol ; 15: 25158414231197064, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37720204

RESUMO

Background: Corneal cross-linking (CXL) is a safe and effective procedure for slowing keratectasia progression in eyes with a corneal thickness of at least 400 µm. Limited research has evaluated the safety and efficacy of epi-off CXL in corneas thinner than 400 µm. Objective: To evaluate the safety and efficacy of CXL to slow keratectasia progression in eyes with <400 µm preoperative corneal thickness. Design: Retrospective chart review. Methods: This retrospective chart review included 37 eyes who underwent epi-off, iso-osmolar riboflavin corneal CXL with a preoperative thinnest point of the cornea <400 µm and had at least 6-12 months of follow-up. Preoperative and postoperative uncorrected visual acuity, best-corrected visual acuity (BCVA), thinnest point of the cornea, flat keratometry, steep keratometry, maximum keratometry (Kmax), need for penetrating keratoplasty, and cases of endothelial failure were recorded. Data were collected at baseline and months 3, 6, 9, and 12 post-CXL. Results: Following cross-linking, 18 eyes (47%) had improved BCVA, 13 (35%) had an unchanged BCVA, and 6 eyes (16%) had a worse BCVA (p = 0.05). The mean postoperative BCVA was 20/81 (0.61 LogMAR) compared to 20/121 (0.78 LogMAR) preoperatively (p = 0.06). Kmax decreased an average of 1.1 D at 3-month (p = 0.53) and 3.4 D at the furthest follow-up (p = 0.10). At the farthest follow-up, 22.7% of eyes had >1 D of Kmax steepening. No patients required keratoplasty and there were no cases of endothelial failure in the follow-up period. Conclusion: This research supports the safety and efficacy of epi-off, iso-osmolar CXL in eyes with <400 µm baseline corneal thickness with no patients requiring penetrating or endothelial keratoplasty, a trend toward improvement in BCVA, and Kmax flattening. In the future, prospective studies would be helpful to confirm these findings.

16.
Clin Ophthalmol ; 17: 843-847, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36937167

RESUMO

Purpose: To create a defocus curve of emerging presbyopic patients of various age groups. Setting: Single site private practice in Sioux Falls, South Dakota. Design: This was a non-randomized, prospective study. All subjects were enrolled from healthy volunteers. Methods: Subjects aged 37-9, 40-42, 43-45 and 46-48 that have 20/20 best-corrected distance visual acuity (BCDVA) were included. Binocular visual acuity at different defocus steps ranging from +0.5 D to -3 D was measured in each age group. Defocus curves were generated from the mean logMAR visual acuities at each defocus step, by age group. Results: Of the 60 subjects, 23.3% of subjects were between the ages of 37-39, 26.7% were between the ages of 40-42, 25% of subjects were between ages 43-45, and 25% were between the ages of 46-48. Visual acuity significantly decreased from plano to -3 D defocus steps in all groups (p < 0.0002, p = 0, p = 0 and p = 0). The 46-48-year-old group had worse visual acuity compared to the other three groups from the -1.0 to -2.0 D defocus steps (p = 0.037, p = 0.022 and 0.017, respectively). Starting at a near point of 40cm, the 37-39 group had the best logMAR vision and the 46-48 group had the worst vision (p = 0.001). Conclusion: The defocus curves of emerging presbyopic individuals demonstrate a decreasing visual acuity at near defocus steps that decreases with age. Defocus curves at different age ranges can help doctors explain various presbyopia treatment options in terms of near point capabilities at various ages.

17.
Eye (Lond) ; 37(8): 1608-1613, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-35945340

RESUMO

OBJECTIVES: To describe the efficacy and safety of goniotomy with trabecular meshwork excision using the Kahook Dual Blade (KDB, New World Medical Inc., Rancho Cucamonga, CA) in patients with severe or refractory glaucoma. METHODS: This retrospective multicentre case series reports on 40 eyes with severe or refractory open-angle glaucoma that underwent standalone or combined KDB goniotomy and were followed for 12 months post-operatively in the United-States, Mexico and Switzerland. Surgical success was defined as an intraocular pressure (IOP) reduction ≥20% from baseline at 12 months, with fewer medications than preoperatively. Mean IOP and antiglaucoma medication reduction, probabilities of achieving an IOP ≤16 or 18 mmHg, and adverse events were also analysed. RESULTS: Mean IOP decreased from 18.1 ± 5.0 mmHg at baseline to 14.8 ± 3.7 mmHg at 12 months (18.2% reduction, P < 0.001). Concomitantly, the mean number of glaucoma medications decreased from 2.5 ± 1.4 to 1.7 ± 1.2 (32% reduction, P = 0.002). The proportion of eyes achieving an IOP reduction of more than 20% from baseline was 37.5% (n = 15) at 12 months. At 12 months, 67.5% and 82.5% achieved a medicated IOP ≤ 16 and ≤18 mmHg, respectively. No severe complications were reported. CONCLUSION: Excisional goniotomy with KDB achieves a statistically significant IOP and antiglaucoma medication reduction in severe or refractory glaucoma over a period of 12 months. While its efficacy decreases with time, its favourable safety profile makes it a potentially useful primary or adjunctive procedure in high-risk eyes.


Assuntos
Glaucoma de Ângulo Aberto , Glaucoma , Hipotensão Ocular , Trabeculectomia , Humanos , Trabeculectomia/métodos , Glaucoma de Ângulo Aberto/cirurgia , Pressão Intraocular , Agentes Antiglaucoma , Tonometria Ocular , Resultado do Tratamento , Glaucoma/cirurgia , Glaucoma/etiologia , Hipotensão Ocular/etiologia , Estudos Retrospectivos
18.
J Cataract Refract Surg ; 48(9): 1050-1056, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-35137696

RESUMO

PURPOSE: To evaluate the safety and effectiveness of a new dispersive ophthalmic viscosurgical device (OVD) (ClearVisc) compared with an approved dispersive OVD (Viscoat) when used in cataract surgery. SETTING: 16 clinics in the United States. DESIGN: Prospective multicenter controlled randomized 1:1 (ClearVisc:Viscoat; stratified by site, age group, and cataract severity). Patients and examiners masked. METHODS: Patients aged 45 years or older with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens (IOL) implantation were included. Patients were randomized to receive either ClearVisc or Viscoat using standard techniques. 5 postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety end point was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority was tested. Inflammation and adverse events were evaluated. RESULTS: 372 patients were randomized: 184 patients in the ClearVisc group and 188 patients in the Viscoat group. ClearVisc was noninferior to Viscoat in mean percentage of ECD loss from baseline to 3 months (8.4% and 6.8%, respectively). ClearVisc was significantly noninferior to Viscoat in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (17.4% and 20.3%, respectively, P = .0002). CONCLUSIONS: ClearVisc dispersive OVD provides surgeons with a new option in the continuum of approved dispersive OVDs with beneficial properties as a surgical aid in cataract extraction and IOL implantation.


Assuntos
Catarata , Facoemulsificação , Sulfatos de Condroitina , Combinação de Medicamentos , Endotélio Corneano , Humanos , Ácido Hialurônico , Pressão Intraocular , Implante de Lente Intraocular , Estudos Prospectivos
19.
Clin Ophthalmol ; 16: 2295-2303, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35903750

RESUMO

Purpose: To evaluate short-term outcomes of combined ab interno canaloplasty and trabeculotomy in pseudophakic eyes with open-angle glaucoma. Patients and Methods: Series included all pseudophakic eyes with open-angle glaucoma treated with up to 360° ab interno canaloplasty and up to 360° ab interno trabeculotomy using a purpose-engineered device (OMNI, Sight Sciences Inc). Data collected prior to surgery and out to 6-months postoperative. Surgical success defined as a 20% reduction in intraocular pressure (IOP) without increase in glaucoma medication, or discontinuation of at least one glaucoma medication without increase in IOP. Other primary endpoints included mean IOP and number of glaucoma medications. Results: The study included 67 eyes of 52 patients with a mean age of 76.5 ± 8.9 years. Preoperative mean IOP was 22.1±8.0 mmHg on 2.3±1.4 glaucoma medications. Pressure lowering effects were sustained out to 6 months postoperative with a mean IOP of 15.2±4.9 mmHg (p < 0.001) and mean medication reduction of 0.7±1.4 (p < 0.001). Surgical success rate was 69.8% (30 eyes) and correlated with preoperative IOP. Two patients required a secondary surgical intervention. Conclusion: Combined ab interno canaloplasty and trabeculotomy as a standalone procedure is an effective means of reducing IOP and medication burden in pseudophakic eyes with open-angle glaucoma.

20.
Int J Ophthalmol ; 15(3): 420-425, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35310054

RESUMO

AIM: To assess the relationship between axial length (AL) and intraocular lens (IOL) rotation among eyes receiving a toric IOL and subsequently entered into an online toric back-calculator database. METHODS: Retrospective analysis of data collected online via astigmatismfix.com, a freely available online toric back-calculator where surgeons enter pre- and post-operative information to help manage residual postoperative astigmatism. Included records were deemed valid with entry of AL and IOL orientation between January 2017 and March 2019. Rotation was determined by a difference of ≥5° between pre-operative intended IOL orientation and actual post-operative IOL orientation. Frequency and magnitude of rotation are presented with means and associated standard deviation (SD). Linear regression models of this association are presented. RESULTS: Records of 6752 eyes were included in the analysis, of which 74.8% were determined to have a rotated IOL. The magnitude of rotation increased with each millimeter (mm) increase in AL with a mean rotation of 13.3° (SD: 12.8°) for eyes with AL 20-20.9 mm and a maximum mean rotation of 30.6° (SD: 30.3°) among eyes with AL 29-29.9 mm. General linear modeling demonstrated a significant association (P<0.0001) with a parameter estimate of 1.19 (standard error: 0.159) and R 2 of 0.0083. CONCLUSION: Analysis from an online database indicates that toric IOLs inserted into eyes with longer AL are more likely to rotate and to rotate more degrees from the target axis. The findings from this study are clinically relevant for surgeons implanting toric IOLs.

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