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1.
Clin Ophthalmol ; 17: 2697-2703, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37720008

RESUMEN

Background: While sutureless, cryopreserved amniotic membrane (cAM) has been shown to significantly improve signs and symptoms of dry eye disease (DED), no studies have assessed the association of cAM treatment duration to the differential response in clinical outcomes. Methods: A multi-center, retrospective study was conducted on patients with moderate-to-severe DED who were treated with self-retained cAM (Prokera® Slim) for 2 to 7 days. The primary outcome measure was DEWS severity score assessed at 1 week, 1 month, and 3 months. Secondary outcome measures included ocular discomfort, visual symptoms, corneal staining, and visual acuity. Results: A total of 89 eyes (77 patients) with moderate-to-severe DED (DEWS severity 3.24 ± 0.56) received treatment with self-retained cAM for 2 days (n = 10), 3 days (n = 15), 4 days (n = 12), 5 days (n = 19), 6 days (n = 6), or 7 days (n = 27). DEWS scores significantly improved at 1 week, 1 month, and 3 months for all treatment duration groups, with no significant difference observed between groups at any timepoint. In addition to an improvement in DEWS severity scores, those receiving cAM treatment for 2 days demonstrated a significant improvement in corneal staining, visual symptoms, and ocular discomfort at 1 week, 1 month, and 3 months. Conclusion: This retrospective study suggests that a single placement of self-retained cAM for 2 days can significantly improve signs and symptoms of DED with a lasting benefit observed for up to 3 months.

2.
Eye (Lond) ; 37(17): 3574-3581, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37173428

RESUMEN

BACKGROUND/OBJECTIVE: Investigate real-world patients receiving faricimab for the treatment of neovascular age-related macular degeneration (nAMD). SUBJECTS/METHODS: Multicenter, retrospective chart review was conducted on patients treated with faricimab for nAMD from February 2022 to September 2022. Collected data includes background demographics, treatment history, best-corrected visual acuity (BCVA), anatomic changes, and adverse events as safety markers. The main outcome measures are changes in BCVA, changes in central subfield thickness (CST) and adverse events. Secondary outcome measures included treatment intervals and presence of retinal fluid. RESULTS: After one injection of faricimab, all eyes (n = 376), previously-treated (n = 337) and treatment-naïve (n = 39) eyes demonstrated a + 1.1 letter (p = 0.035), a + 0.7 letter (p = 0.196) and a + 4.9 letter (p = 0.076) improvement in BCVA, respectively, and a - 31.3 µM (p < 0.001), a - 25.3 µM (p < 0.001) and a - 84.5 µM (p < 0.001) reduction in CST, respectively. After three injections of faricimab, all eyes (n = 94), previously-treated (n = 81) and treatment-naïve (n = 13) eyes demonstrated a + 3.4 letter (p = 0.03), a + 2.7 letter (p = 0.045) and a + 8.1 letter (p = 0.437) improvement in BCVA, and a - 43.4 µM (p < 0.001), a - 38.1 µM (p < 0.001) and a - 80.1 µM (p < 0.204) reduction in CST, respectively. One case of intraocular inflammation was observed after four injections of faricimab and resolved with topical steroids. One case of infectious endophthalmitis was treated with intravitreal antibiotics and resolved. CONCLUSIONS: Faricimab has demonstrated improvement or maintenance of visual acuity for patients with nAMD, along with rapid improvement of anatomical parameters. It has been well-tolerated with low incidence of treatable intraocular inflammation. Future data will continue to investigate faricimab for real-world patients with nAMD.


Asunto(s)
Inhibidores de la Angiogénesis , Degeneración Macular , Humanos , Inhibidores de la Angiogénesis/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Inyecciones Intravítreas , Degeneración Macular/tratamiento farmacológico , Inflamación
3.
Retina ; 43(1): 25-33, 2023 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-36542081

RESUMEN

PURPOSE: AR-1105 is a novel biodegradable sustained-release dexamethasone implant designed to deliver 6-month durability. This Phase 2 study evaluated two AR-1105 formulations with different release profiles in patients with macular edema due to retinal vein occlusion. METHODS: Patients received a single intravitreal injection with 340 µg dexamethasone. In the initial phase, five patients received clinical formulation (CF) 1. In the randomized phase, 44 patients were randomized 1:1 to CF1 or CF2. The follow-up was 6 months. Patients had vision loss due to macular edema diagnosed ≥9 (central retinal vein occlusion) or ≥12 months (branch retinal vein occlusion) before screening, and could be treatment-naive or -experienced (if received prior steroids, must have demonstrated response). RESULTS: Both formulations improved vision and reduced retinal thickening from baseline across all visits. At Month 6, mean changes in best-corrected visual acuity were +4.3 and +8.0 letters, and mean changes in central subfield thickness were -93 µm and -211 µm in CF1 and CF2 randomized patients, respectively. Most common adverse events were reduced visual acuity, worsening macular edema, conjunctival hemorrhage, and increased intraocular pressure. No patients required surgery or laser for intraocular pressure control. CONCLUSION: Both formulations were well tolerated and demonstrated clinically meaningful and sustained improvements in vision and retinal thickening in patients with retinal vein occlusion with longstanding edema.


Asunto(s)
Edema Macular , Oclusión de la Vena Retiniana , Humanos , Oclusión de la Vena Retiniana/complicaciones , Oclusión de la Vena Retiniana/diagnóstico , Oclusión de la Vena Retiniana/tratamiento farmacológico , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Dexametasona , Glucocorticoides , Resultado del Tratamiento , Implantes de Medicamentos , Tomografía de Coherencia Óptica , Inyecciones Intravítreas
4.
Ophthalmology ; 129(6): 605-613, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-35063472

RESUMEN

PURPOSE: To assess the long-term safety and efficacy of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien; Alimera Sciences, Inc) in patients with diabetic macular edema (DME). DESIGN: Three-year, phase 4, nonrandomized, open-label observational study. PARTICIPANTS: Patients with DME who previously received corticosteroid treatment without a clinically significant rise in intraocular pressure (IOP; all eyes, n = 202 eyes of 159 patients; 36-month completion, n = 94 eyes). METHODS: A prospective, observational study in which patients received a 0.19-mg FAc intravitreal implant at baseline and then were observed for safety-, visual-, anatomic-, and treatment burden-related outcomes for up to 36 months. MAIN OUTCOME MEASURES: Primary safety outcomes included changes in IOP and interventions to manage IOP elevations. Secondary outcomes included changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and adjunctive DME treatment frequency RESULTS: At 36 months after FAc implantation, study eyes showed a mean CST change of -60.69 µm (P < 0.0001) and a mean BCVA change of +3.61 letters (P = 0.0222) compared with baseline. Overall median treatment frequency decreased from 3.4 treatments/year in the 36 months before FAc implantation to 1 treatment/year in the 36 months after FAc implant, a treatment burden reduction of 70.5%. Furthermore, among the group that completed 36 months of treatment (n = 94 eyes), 25.53% of eyes remained rescue free through 36 months. Mean IOP remained stable throughout the study, and IOP increases to more than 30 mmHg occurred in 10.89% of eyes. Intraocular pressure-related procedures were infrequent, with a surgical rate of 2.97%, with 1.49% attributable to steroid use (vs. surgeries attributable primarily to neovascular glaucoma). In addition, an IOP response of < 25 mmHg after the steroid challenge predicted that 96.92% of eyes would have a similar outcome to 0.19-mg FAc implant at the last visit. Intraocular pressure increases that did occur were manageable with standard treatments (n = 202 eyes). CONCLUSIONS: In patients with DME, the 0.19-mg FAc implant provided improved visual outcomes and reduced treatment burden compared with previous treatments while maintaining a favorable safety profile.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Retinopatía Diabética/complicaciones , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Implantes de Medicamentos/uso terapéutico , Fluocinolona Acetonida , Glucocorticoides/uso terapéutico , Humanos , Inyecciones Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Estudios Prospectivos , Esteroides/uso terapéutico , Agudeza Visual
5.
Clin Exp Ophthalmol ; 50(1): 23-30, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34741564

RESUMEN

BACKGROUND: This post hoc analysis compared the efficacy and safety of suprachoroidally administered triamcinolone acetonide (CLS-TA) to other commonly available treatments for non-infectious uveitis. METHODS: Results from the PEACHTREE study were compared between subjects randomised to CLS-TA not requiring rescue therapy and those subjects randomised to control, who subsequently required rescue therapy. Endpoints included best corrected visual acuity (BCVA), central subfield thickness (CST), treatment emergent adverse events and intraocular pressure (IOP) related safety findings. RESULTS: In this analysis, there were 83 unrescued CLS-TA subjects and 46 rescued control subjects. At Week 24, 51.9% of the unrescued CLS-TA subjects gained ≥15 letters in BCVA, compared to 37.0% of the rescued control subjects (p = 0.115). Unrescued CLS-TA subjects showed a mean gain of 15.7 versus 10.9 letters in rescued control subjects (p = 0.080). A significantly greater mean reduction in CST was observed for unrescued CLS-TA subjects versus rescued control subjects (174.0 and 148.5 µm; p = 0.040). Of unrescued CLS-TA subjects, 4.9% experienced IOP elevations ≥30 mm Hg at any visit versus 10.9% of rescued control subjects. Further, use of IOP-lowering medications appeared lower in unrescued CLS-TA subjects versus rescued control subjects (7.2% vs. 13.0%). There were no IOP-lowering surgical interventions in either group. CONCLUSION: CLS-TA subjects experienced significantly greater reduction in CST and tended towards greater improvement in BCVA, compared with rescued control subjects. Suprachoroidally administered CLS-TA showed a lower incidence of IOP-related safety findings.


Asunto(s)
Edema Macular , Uveítis , Glucocorticoides/uso terapéutico , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Tomografía de Coherencia Óptica/métodos , Resultado del Tratamiento , Triamcinolona Acetonida/uso terapéutico , Uveítis/complicaciones , Uveítis/diagnóstico , Uveítis/tratamiento farmacológico , Agudeza Visual
6.
Ophthalmic Surg Lasers Imaging Retina ; 52(7): 387-390, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34309426

RESUMEN

BACKGROUND AND OBJECTIVE: Characterize timing of intraocular pressure (IOP) elevation in patients treated with fluocinolone acetonide insert (FAi) for uveitis. PATIENTS AND METHODS: A post-hoc subset analysis of data from a randomized, prospective, double-masked, sham-controlled, 3-year, phase 3 clinical trial with 129 participants with noninfectious posterior uveitis randomly assigned to receive 0.18-mg fluocinolone acetonide insert or sham injection. The number of eyes with IOP of 30 mm Hg or greater at different time points were recorded. RESULTS: The incidence of FAi eyes that reached IOP 30 mm Hg or greater was 17.2%. The mean number of days to first IOP response was 241. IOP elevations were divided into four time periods: under 1 month (33%), 3 to 6 months (33%), 6 to 18 months (26.7%), and greater than 18 months (6.7%). Ten cases of elevated IOP were managed medically and five required surgical management. Visual field analysis revealed no significant change in mean deviation compared to patients' own, untreated eyes (P > .05). CONCLUSIONS: IOP elevations occurred in 15 out of 87 patients treated with the FAi. The onset of elevated IOP was fairly evenly distributed across the 36-month trial. Patients should be regularly evaluated for increased IOP, which can be successfully managed by traditional means. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:387-390.].


Asunto(s)
Uveítis Posterior , Uveítis , Implantes de Medicamentos , Fluocinolona Acetonida , Glucocorticoides , Humanos , Presión Intraocular , Estudios Prospectivos , Uveítis/diagnóstico , Uveítis/tratamiento farmacológico , Uveítis Posterior/diagnóstico , Uveítis Posterior/tratamiento farmacológico , Agudeza Visual
7.
Ophthalmic Surg Lasers Imaging Retina ; 52(6): 327-335, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-34185587

RESUMEN

BACKGROUND AND OBJECTIVE: To evaluate the safety and efficacy of 1.0 mg risuteganib in subjects with nonexudative age-related macular degeneration (AMD). PATIENTS AND METHODS: This was a phase 2a, prospective, double-masked, sham-controlled study. Eyes with nonexudative (dry) AMD and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 20/40 and 20/200 were included. Subjects were randomized to intravitreal 1.0 mg risuteganib or sham injection. At Week 16, subjects in the risuteganib group received a second 1.0-mg dose and the sham group crossed over to receive a dose of 1.0 mg risuteganib and were evaluated at Week 28. The primary endpoint was proportion of subjects with 8 letters ETDRS or more BCVA gain from baseline to Week 28 in the risuteganib group versus baseline to Week 12 for the sham group. BCVA was tested and subjects were observed for adverse events (AEs) every 4 weeks until completion of the study at 32 weeks. RESULTS: Forty-five subjects (risuteganib, n = 29; sham, n = 16) were enrolled in the study, of whom 39 (risuteganib, n = 25; sham, n = 14) completed the study and were included in the per protocol efficacy analysis. At baseline, mean age was 78.8 and 75.9 years and mean BCVA was 67.1 and 64.4 letters in the sham and risuteganib groups, respectively. The primary endpoint was met by 48% of the risuteganib group at Week 28 and 7% of the sham group at Week 12 (P = .013). Of the risuteganib subjects, 20% gained 15 letters or more at Week 28, whereas no patients in the sham group at Week 12 achieved this visual acuity gain. The only ocular treatment-related treatment-emergent AE was vitreous floaters, which spontaneously recovered without sequelae. No drug-related serious AE was reported. CONCLUSIONS: Risuteganib demonstrated significant BCVA improvement in patients with non-exudative AMD. No drug-related AEs were seen during a 32-week observation period. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:327-335.].


Asunto(s)
Inhibidores de la Angiogénesis , Retinopatía Diabética , Inhibidores de la Angiogénesis/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico , Método Doble Ciego , Humanos , Inyecciones Intravítreas , Estudios Prospectivos , Resultado del Tratamiento , Agudeza Visual
8.
Ophthalmic Surg Lasers Imaging Retina ; 51(11): 658-667, 2020 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-33231701

RESUMEN

BACKGROUND AND OBJECTIVE: Exploratory investigation of the effect of diabetic macular edema (DME) control with the 0.2 µg/day fluocinolone acetonide (FAc) intravitreal implant on quality of life (QOL) outcomes. PATIENTS AND METHODS: Post-hoc analysis of patients from the FAME study who received the FAc implant and had answered the National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ-25) at baseline and Year 3 (N = 324). Patients were divided into quartiles (area under the curve [AUC]-central subfield thickness [CST]/day; n = 81/quartile). NEIVFQ-25 and best-corrected visual acuity (BCVA) changes were analyzed per quartile during a period of 3 years. RESULTS: NEI-VFQ-25 scores were significantly higher in patients with low AUC-CST/day (Quartiles 1 [P < .001] and 2 [P = .004]). Increases in NEIVFQ-25 subscale scores correlated with AUC-CST/day quartiles. BCVA significantly improved in patients with the lowest AUC-CST/day (Quartiles 1 and 2 [P < .001]). CONCLUSION: There was a positive and sustained correlation between the long-term control of DME and patient-reported QOL outcomes for up to 3 years following a single FAc implant in patients with controlled DME. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:658-667.].


Asunto(s)
Retinopatía Diabética , Edema Macular , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Implantes de Medicamentos , Fluocinolona Acetonida , Glucocorticoides/uso terapéutico , Humanos , Inyecciones Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Calidad de Vida , Agudeza Visual
9.
Clin Ophthalmol ; 13: 1543-1548, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31616132

RESUMEN

PURPOSE: Central serous chorioretinopathy (CSCR) is a common retinopathy that is often observed until resolution. The purpose of this study is to evaluate the effects of topical nonsteroidal anti-inflammatory drugs (NSAIDs) on timing of CSCR recovery. METHODS: An IRB-approved retrospective review was conducted on patients that had been diagnosed with a new-onset, symptomatic case of CSCR. Patients were either observed only (13 untreated eyes) or treated with topical bromfenac or nepafenac (14 eyes) over an average of about a 4-5 week follow-up period. RESULTS: There was no statistical significance between central macular thickness (CMT) and visual acuity of treatment and control groups at the initial presentation. However, at the follow-up visit, CMT reductions in the treatment group were significantly higher than in the control group (p<0.006). CONCLUSION: Use of topical NSAIDs in the treatment of acute CSCR leads to a faster rate of reduction in the subretinal fluid volume over a follow-up period of a few weeks.

10.
Clin Ophthalmol ; 13: 1079-1086, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31417237

RESUMEN

Background and objective: The dexamethasone (DEX) implant is known to cause temporary intraocular pressure (IOP) spikes after implantation. The purpose of this study is to determine if IOP spikes after DEX implant cause significant thinning in the retinal nerve fiber layer (RNFL). Study design, patients, and methods: A total of 306 charts were reviewed with 48 and 21 patients meeting inclusion criteria for the cross-sectional and prospective groups, respectively. Cross-sectional inclusion criteria: IOP spike ≥22 mmHg up to 16 weeks after DEX implant, DEX implant in only 1 eye per patient, and spectral-domain optical coherence tomography (OCT) RNFL imaging of both eyes ≥3 months after IOP spike. Prospective inclusion criteria: OCT RNFL performed within 1 year prior to DEX implantation, IOP spike ≥22 mmHg up to 16 weeks after DEX implant, and OCT RNFL performed ≥3 months after IOP spike. The average RNFL thickness in the contralateral eye was used as the control in the cross-sectional group. Institutional review board approval was obtained. Results: In the cross-sectional group, there was no statistically significant difference in the mean RNFL thicknesses in the treated vs untreated eyes (80.4±15.5 µm and 82.6±15.8 µm, respectively; P=0.33) regardless of treatment diagnosis, magnitude of IOP spike, or history of glaucoma. In the prospective group, mean RNFL thicknesses before and after IOP spikes ≥22 mmHg were similar (78.0±14.8 µm and 75.6±13.6 µm, respectively; P=0.13). Conclusion and relevance: Temporary elevation of IOP after DEX implantation when treated with topical IOP lowering drops does not appear to lead to a meaningful change in RNFL thickness.

11.
Ophthalmic Surg Lasers Imaging Retina ; 50(2): e23-e25, 2019 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-30768225

RESUMEN

BACKGROUND AND OBJECTIVES: Ozurdex intravitreal injection is performed via a patented injection device. However, there is a common misconception among ophthalmologists regarding the relation between the speed of applicator button depression and the speed of pellet injection. PATIENTS AND METHODS: Six dexamethasone intravitreal implants were injected into a calibrated ex vivo water bath. Three of the pellets were injected via rapid compression, whereas the other three implants were injected using a 3-second compression technique. The procedures were recorded using high-speed photography followed by calculation of pellet velocity and impact force. RESULTS: The mean impact velocity and force of the pellet insertion is significantly higher in the fast injection group compared to the slow injection group. CONCLUSIONS: By depressing the Ozurdex implant injector during a 3-second time interval, the impact force of the implant pellet is reduced by about 95%. This new technique will theoretically reduce the risk of retinal injury and vitreous hemorrhage from Ozurdex injections. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:e23-e25.].


Asunto(s)
Dexametasona/administración & dosificación , Implantes de Medicamentos , Glucocorticoides/administración & dosificación , Inyecciones Intravítreas/métodos , Humanos , Inyecciones Intravítreas/instrumentación , Edema Macular/tratamiento farmacológico
12.
Ocul Oncol Pathol ; 4(6): 375-380, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-30574490

RESUMEN

OBJECTIVE: To determine whether increased choroidal thickness (CT) is associated with circumscribed choroidal hemangioma (CCH) and whether patients with CCH are predisposed to central serous chorioretinopathy (CSCR). METHODS: We performed a retrospective consecutive observational study of 15 fellow eyes of 15 patients who had CCH. A- and B-scan ultrasonography, fluorescein angiography (FA), and optical coherence tomography (OCT) findings were reviewed to confirm the diagnosis of CCH. Fellow eye CT was measured using enhanced depth imaging OCT. FA, indocyanine green angiography, and OCT images of fellow eyes were reviewed for signs of CSCR. RESULTS: Mean subfoveal CT was significantly greater in the fellow eyes of patients with CCH than in age-matched normal eyes (p = 0.004). Three of 15 (20.0%) fellow eyes of CCH patients had retinal pigment epithelium disruptions and/or pigment epithelial detachments indicative of previous asymptomatic CSCR. CONCLUSION: In this pilot study, elevated CT was associated with a risk of developing CCH as well as CSCR in patients of varying ages. Patients diagnosed with CCH should be screened for CSCR in the fellow eye. Further exploration of this association may reveal useful clues about the biology of abnormally elevated choroidal hyperpermeability and its various clinical manifestations.

13.
Ophthalmic Surg Lasers Imaging Retina ; 49(9): 698-706, 2018 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-30222805

RESUMEN

BACKGROUND AND OBJECTIVE: Visual outcomes of the FAME study (0.2 µg/day fluocinolone acetonide [FAc]) and Protocol I (0.5 mg ranibizumab plus deferred laser) were compared using the area under the curve (AUC) analysis method. PATIENTS AND METHODS: Best-corrected visual acuity (BCVA) data collected during a period of 3 years of follow-up for patients enrolled in FAME or Protocol I were used to calculate AUC of the change in BCVA over a time curve. RESULTS: In the overall population, there was a greater treatment effect for ranibizumab plus deferred laser compared with FAc. However, for subgroups of pseudophakic eyes, eyes with chronic diabetic macular edema (DME), and pseudophakic eyes with chronic DME, ranibizumab plus deferred laser and FAc were not found to be significantly different. The ranibizumab group received a median of 14 injections during a 36-month period compared with a mean of 1.3 injections in the FAc group. CONCLUSION: In pseudophakic and chronic DME subgroups, FAc was comparable to ranibizumab plus deferred laser with fewer injections. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:698-706.].


Asunto(s)
Retinopatía Diabética/terapia , Fluocinolona Acetonida/administración & dosificación , Coagulación con Láser/métodos , Edema Macular/terapia , Ranibizumab/administración & dosificación , Agudeza Visual , Inhibidores de la Angiogénesis/administración & dosificación , Retinopatía Diabética/complicaciones , Retinopatía Diabética/diagnóstico , Femenino , Estudios de Seguimiento , Glucocorticoides/administración & dosificación , Humanos , Inyecciones Intravítreas , Edema Macular/diagnóstico , Edema Macular/etiología , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
14.
Ophthalmic Surg Lasers Imaging Retina ; 49(6): 425-435, 2018 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-29927470

RESUMEN

BACKGROUND AND OBJECTIVE: Dexamethasone intravitreal implant (DEX) (Ozurdex; Allergan plc, Dublin, Ireland) is approved for the treatment of diabetic macular edema (DME). This study assessed the real-world effectiveness, safety, and reinjection interval of DEX in adult patients with DME. PATIENTS AND METHODS: This was a phase 4, prospective, multicenter (18 U.S. sites), observational study. RESULTS: The study population comprised 177 patients (180 eyes; 93.8% previously treated). Baseline mean best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were 54.4 letters and 424.6 µm, respectively. DEX was administered as monotherapy or with other DME therapy (55%/45%). The mean reinjection interval was 5.0 months. Mean maximum BCVA change from baseline after the first three DEX injections was +9.1 letters, +7.7 letters, and +7.0 letters, respectively (P < .001); 36.0% of eyes achieved 15-letter or greater BCVA improvement. Mean maximum CRT change from baseline was -137.7 µm (P < .001). CONCLUSION: DEX used alone or with other DME therapy improved visual and anatomic outcomes in DME patients in clinical practice, with no new safety concerns. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:425-435.].


Asunto(s)
Antiinflamatorios/administración & dosificación , Dexametasona/administración & dosificación , Retinopatía Diabética/tratamiento farmacológico , Implantes de Medicamentos , Glucocorticoides/administración & dosificación , Edema Macular/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Tomografía de Coherencia Óptica , Agudeza Visual
15.
Clin Ophthalmol ; 12: 677-681, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29670328

RESUMEN

PURPOSE: To evaluate the efficacy of cryopreserved amniotic membrane (CAM) in reducing signs and symptoms of dry eye disease (DED) in a large patient population. METHODS: A retrospective chart review at 10 clinical sites was done of patients with refractory DED who received CAM and completed at least 3 months of follow-up. Data collected were demographics; medical history including previous and current ocular treatment, diagnosis, clinical presentations, comorbidity, duration and frequency of treatment with CAM; and concomitant medications. The primary outcome was the change in dry eye workshop (DEWS) score after treatment. RESULTS: A total of 97 eyes of 84 patients exhibited severe dry eye despite maximal medical treatments including topical artificial tears, cyclosporine-A, serum, antibiotics, and steroids. Patients manifested with superficial punctate keratitis (86%), filamentary keratitis (13%), exposure keratitis (19%), neurotrophic keratitis (2%), and corneal epithelial defect (7%). After CAM treatment for 5.4±2.8 days, 74 (88%) patients demonstrated an improved ocular surface along with a notable reduction of the severity as the overall DEWS score was significantly reduced from 3.25±0.5 at baseline to 1.44±0.6 at 1 week, 1.45±0.6 at 1 month, and 1.47±0.6 at 3 months (p<0.001). Ten eyes (10%) required repeated treatment to complete healing. Apart from discomfort during CAM placement, there were no adverse events. CONCLUSION: Placement of CAM is promising to enhance the recovery of ocular surface health and reduce signs and symptoms in patients with moderate-to-severe DED.

16.
Clin Ophthalmol ; 12: 639-642, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29662300

RESUMEN

PURPOSE: The purpose of this study was to correlate the degree of ocular hypertension with the number of Ozurdex injections. METHODS: Intraocular pressure (IOP) fluctuations for a total of 183 injections were studied over a period of at least 12 months. The main indications for treatment were uveitis, diabetic macular edema, and retinal vein occlusion. RESULTS: Results of the study demonstrate that repeated Ozurdex injections do not increase the frequency of IOP spikes beyond 30 mmHg. For lower IOPs, however, a positive correlation exists. Furthermore, patients with primary open angle glaucoma and uveitis had the highest IOP response to repeated injections. On average, patients with an IOP of ≥28.6 mmHg received pressure lowering medications, after which their IOP reached a stable level (16.7 mmHg) without the need for additional interventions. CONCLUSION: The data support the conclusion that multiple Ozurdex injections does not increase the frequency of IOP spikes beyond 30 mmHg, but patients still must be closely monitored if they have a history of primary open angle glaucoma.

17.
Ophthalmic Surg Lasers Imaging Retina ; 49(3): 186-190, 2018 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-29554386

RESUMEN

BACKGROUND AND OBJECTIVE: The purpose of this study is to compare cancellation and no-show rates in patients with diabetic macular edema (DME) and exudative macular degeneration (wet AMD). PATIENTS AND METHODS: An anonymous survey was sent to 1,726 retina specialists inquiring as to the number of appointments their patients with DME and wet AMD attended, cancelled, or did not show up for in 2014 and 2015. RESULTS: Data were obtained on 109,599 appointments. Patients with DME in the U.S. had a 1.591-times increased odds of cancelling or no-showing to their appointments than patients with wet AMD (P < .0001). Patients with DME in Europe had a 1.918-times increased odds of cancelling or no showing to their appointments than patients with wet AMD (P < .0001). CONCLUSION: Patients with DME in the U.S. and Europe cancelled and no-showed to their appointments significantly more often than patients with wet AMD. These findings can be taken into consideration when establishing treatment plans for patients with DME. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:186-190.].


Asunto(s)
Inhibidores de la Angiogénesis/administración & dosificación , Citas y Horarios , Retinopatía Diabética/tratamiento farmacológico , Edema Macular/tratamiento farmacológico , Cooperación del Paciente , Agudeza Visual , Degeneración Macular Húmeda/tratamiento farmacológico , Anciano , Retinopatía Diabética/diagnóstico , Femenino , Humanos , Inyecciones Intravítreas , Edema Macular/diagnóstico , Masculino , Tomografía de Coherencia Óptica , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Degeneración Macular Húmeda/diagnóstico
18.
Cell ; 172(5): 1122-1131.e9, 2018 02 22.
Artículo en Inglés | MEDLINE | ID: mdl-29474911

RESUMEN

The implementation of clinical-decision support algorithms for medical imaging faces challenges with reliability and interpretability. Here, we establish a diagnostic tool based on a deep-learning framework for the screening of patients with common treatable blinding retinal diseases. Our framework utilizes transfer learning, which trains a neural network with a fraction of the data of conventional approaches. Applying this approach to a dataset of optical coherence tomography images, we demonstrate performance comparable to that of human experts in classifying age-related macular degeneration and diabetic macular edema. We also provide a more transparent and interpretable diagnosis by highlighting the regions recognized by the neural network. We further demonstrate the general applicability of our AI system for diagnosis of pediatric pneumonia using chest X-ray images. This tool may ultimately aid in expediting the diagnosis and referral of these treatable conditions, thereby facilitating earlier treatment, resulting in improved clinical outcomes. VIDEO ABSTRACT.


Asunto(s)
Aprendizaje Profundo , Diagnóstico por Imagen , Neumonía/diagnóstico , Niño , Humanos , Redes Neurales de la Computación , Neumonía/diagnóstico por imagen , Curva ROC , Reproducibilidad de los Resultados , Tomografía de Coherencia Óptica
19.
Ophthalmic Surg Lasers Imaging Retina ; 48(4): 291-301, 2017 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-28419394

RESUMEN

BACKGROUND AND OBJECTIVE: Guidance on the use of corticosteroids in the treatment of diabetic macular edema (DME) is lacking. This study aimed to develop a clinically recommended treatment paradigm for DME with emphasis on the role of corticosteroids. PATIENTS AND METHODS: An expert panel of nine retinal specialists in the United States developed consensus recommendations for DME treatment through a modified Delphi process. RESULTS: The panelists typically use intravitreal injections of vascular endothelial growth factor (VEGF) antagonists as first-line treatment of DME and switch patients with an inadequate response to anti-VEGF therapy (failure of best-corrected visual acuity to improve to 20/40 or better because of edema after three to six monthly injections, or a less-than-50% reduction in excess macular thickness after three to four monthly injections) to intravitreal corticosteroid treatment. CONCLUSION: Intravitreal corticosteroids have a potentially useful role in the treatment of patients with DME who have an inadequate response to intravitreal anti-VEGF therapy. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:291-301.].


Asunto(s)
Toma de Decisiones , Retinopatía Diabética/tratamiento farmacológico , Testimonio de Experto/métodos , Glucocorticoides/administración & dosificación , Edema Macular/tratamiento farmacológico , Encuestas y Cuestionarios , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Inhibidores de la Angiogénesis/administración & dosificación , Técnica Delphi , Retinopatía Diabética/complicaciones , Retinopatía Diabética/diagnóstico , Estudios de Seguimiento , Humanos , Inyecciones Intravítreas , Edema Macular/diagnóstico , Edema Macular/etiología , Estudios Retrospectivos , Tomografía de Coherencia Óptica , Agudeza Visual
20.
Clin Ophthalmol ; 11: 31-38, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28031700

RESUMEN

BACKGROUND: One limitation of anti-VEGF therapy is the need for monthly retreatment to maintain efficacy. The purpose of this study was to determine the duration of effect in eyes with macular edema (ME) secondary to branch or central retinal vein occlusion (BRVO or CRVO) treated with anti-VEGF therapy plus sustained-release dexamethasone (DEX implant; Ozurdex). MATERIALS AND METHODS: This open-label, interventional case series included 62 eyes with ME due to RVO, central foveal thickness (CFT) >300 µm, and best-corrected visual acuity (BCVA) of 20/40 or worse. Each treatment cycle included an anti-VEGF injection followed 2 weeks later with DEX implant. Patients were eligible for retreatment if CFT increased to >290 µm or increased by >50 µm from the lowest measurement, or if BCVA decreased by six or more Snellen letters. Efficacy and safety were evaluated 2 and 4-6 weeks after the beginning of each treatment cycle and every 4 weeks thereafter until retreatment criteria were met. The primary outcome measure was time to retreatment. Secondary outcome measures included BCVA, CFT, and safety parameters. RESULTS: The mean reinjection interval for all patients was 135.5±36.4 days. There was no statistically significant difference in mean intertreatment interval for up to six cycles of treatment or between eyes with BRVO or CRVO (P≥0.058). Mean peak change in BCVA was 13.8 letters, and 47.6% of eyes gained three or more lines of BCVA. The mean peak decrease in CFT across all treatment cycles was 200.9 µm for eyes with BRVO and 219.2 µm for eyes with CRVO. The percentage of patients with CFT ≤300 µm at any time during a given treatment cycle ranged from 78% to 94% among eyes with BRVO and from 85% to 100% among eyes with CRVO. Intraocular pressure increased in 19 of 62 eyes, and 26 of 44 phakic eyes underwent cataract surgery. CONCLUSION: In eyes with ME due to RVO, treatment with an anti-VEGF agent plus DEX implant provided a predictable duration of effect, as well as significant improvements in BCVA and CFT.

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