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1.
Artigo em Inglês | MEDLINE | ID: mdl-38574678

RESUMO

PURPOSE: Comparison of safety and clinical results of Descemet membrane endothelial keratoplasty (DMEK) in topical, peribulbar, or general anesthesia. METHODS: Retrospective, post hoc matched study of 346 patients who received DMEK surgery with different types of anesthesia (n = 54 topical, n = 137 peribulbar, n = 155 general anesthesia). Outcome criteria were intraoperative complications, endothelial cell count (ECC), central corneal thickness (CCT) and graft rejection rate, rebubbling rate, and visual acuity (VA). Mean follow-up time was 9.4 ± 2.8 months. RESULTS: The group with topical anesthesia showed intraoperative difficulties such as vitreous pressure (p = 0.01) and difficult graft unfolding (p = 0.4), possibly leading to a higher rebubbling rate (p = 0.03) and therefore graft failure (p = 0.39). However, rebubbling and graft failure occurred more often when the graft preparation was more difficult (p = 0.2, p = 0.13, respectively), which was independent of anesthesia. All three groups achieved comparable functional results regarding VA, ECC, and CCT after 6 months. CONCLUSION: DMEK under topical anesthesia is feasible and shows comparable final visual outcomes but should be limited to selected cooperative patients and performed by experienced surgeons due to the potential for increased intraoperative challenges.

3.
Artigo em Inglês | MEDLINE | ID: mdl-38662577

RESUMO

PURPOSE: To investigate the long-term astigmatism after combined non-penetrating glaucoma surgery (NPGS) and implantation of the first miniaturized suprachoroidal intraocular pressure (IOP) sensor EYEMATE-SC. SETTING: The study was conducted in five medical centers in two different countries. DESIGN: Retrospective multicenter clinical study. METHODS: Astigmatism of patients instrumented with the EYEMATE-SC IOP sensor was assessed over a follow-up period of three years. Refraction and corrected distance visual acuity (CDVA) were obtained preoperatively, after 6 months, 1, 2, and 3 years. A canaloplasty-operated patient cohort served as control. Astigmatism was evaluated using 3-dimensional power vector analysis involving the spherical equivalent M, and the Jackson crossed cylinder projections J0 and J45. Exclusion criteria included neovascular and angle-closure glaucoma, myopia, axial length outside 22 to 26 mm, other ocular diseases, prior glaucoma surgery, other ocular surgery within 6 months (cataract surgery within 3 months) prior to NPGS, serious generalized conditions, and other active medical head/neck implants. RESULTS: Multivariate analysis indicated no changes in astigmatism along the observation period in both the EYEMATE-SC (n = 24) and the canaloplasty (n = 24) group (P > 0.05 or nonsignificant after Bonferroni correction). Astigmatism was unchanged between the EYEMATE-SC and the canaloplasty group at all time points (P > 0.05). CDVA didn't change along the observation period of three years in each of both groups (P > 0.05). CONCLUSIONS: Despite its suprachoroidal localization, the present study indicates that the miniaturized EYEMATE-SC IOP sensor doesn't negatively affect the long-term astigmatism after combined implantation with NPGS.

5.
Pathologie (Heidelb) ; 44(Suppl 3): 150-154, 2023 Dec.
Artigo em Alemão | MEDLINE | ID: mdl-37947807

RESUMO

Primary vitreoretinal lymphoma (PVRL) represents a subtype of intraocular lymphomas, which are a subgroup of malignant lymphomas of the eye. PVRL is considered a special form of primary diffuse large cell lymphoma (DLBCL) of the CNS (central nervous system) (PCNSL) and arises primary or secondary to PCNSL. According to the cell of origin (COO) classification of DLBCL, PVRL largely belongs to the activated B­cell (ABC) type of DLBCL. Based on a recently established genetic-biological classification of DLBCL, PCNSL and thus also PVRL belong to a group of DLBCL of the MYD88/CD79B-mutated (MCD) or cluster 5 subtype, which often shows extranodal manifestations and MYD88 and CD79A mutations as well as CDKN2A deletions.PVRL diagnostics is often complicated as it represents a classic masquerade syndrome. Due to the usually limited material with often large numbers of reactive lymphocytes and/or degenerative changes in the cells, the results of diagnostic tests are difficult to interpret. Classic diagnostic tests include cytology on vitreous aspirates, immunocytochemistry, and clonality analysis.New insights into the spectrum of genetic alterations of vitreoretinal lymphomas (VRL) confirm the close relationship to PCNSL and could significantly improve pathological diagnosis. Next-generation sequencing panel-based diagnostics allow VRL diagnosis confirmation with little DNA in almost 100% of patients in cases with insufficient cytological evidence or lack of clonality detection. PVRL, as well as secondary vitreoretinal lymphomas after PCNSL or extracerebral DLBCL, have high mutation frequencies in characteristically mutated genes in PCNSL or MCD/cluster 5 type DLBCL. Supporting diagnostics, mutation detection can also be performed on cell-free DNA from the vitreous supernatant.


Assuntos
Neoplasias do Sistema Nervoso Central , Neoplasias Oculares , Linfoma Difuso de Grandes Células B , Neoplasias da Retina , Humanos , Neoplasias da Retina/diagnóstico , Fator 88 de Diferenciação Mieloide/genética , Patologia Molecular , Corpo Vítreo/metabolismo , Neoplasias Oculares/diagnóstico , Linfoma Difuso de Grandes Células B/diagnóstico , Neoplasias do Sistema Nervoso Central/metabolismo
6.
J Clin Med ; 12(8)2023 Apr 21.
Artigo em Inglês | MEDLINE | ID: mdl-37109367

RESUMO

For decades, trabeculectomy (TE) was considered the gold standard for surgical treatment of open-angle glaucoma owing to its powerful intraocular pressure (IOP)-lowering potency. However, owing to the invasive nature and high-risk profile of TE, this standard is changing, and minimally invasive procedures are becoming more preferable. In particular, canaloplasty (CP) has been established as a much gentler alternative in everyday life and is under development as a full-fledged replacement. This technique involves probing Schlemm's canal with a microcatheter and inserting a pouch suture that places the trabecular meshwork under permanent tension. It aims to restore the natural outflow pathways of the aqueous humor and is independent of external wound healing. This physiological approach results in a significantly lower complication rate and allows considerably simplified perioperative management. There is now extensive evidence that canaloplasty achieves sufficient pressure reduction as well as a significant reduction in postoperative glaucoma medications. Unlike MIGS procedures, the indication is not only mild to moderate glaucoma; today, even advanced glaucoma benefits from the very low hypotony rate, which largely avoids a wipeout phenomenon. However, approximately half of patients are not completely medication-free after canaloplasty. As a consequence, a number of canaloplasty modifications have been developed with the goal of further enhancing the IOP-lowering effect while avoiding the risk of serious complications. By combining canaloplasty with the newly developed suprachoroidal drainage procedure, the individual improvements in trabecular facility and uveoscleral outflow facility appear to have an additive effect. Thus, for the first time, an IOP-lowering effect comparable to a successful trabeculectomy can be achieved. Other implant modifications also enhance the potential of canaloplasty or offer additional benefits such as the possibility of telemetric IOP self-measurement by the patient. This article reviews the modifications of canaloplasty, which has the potential to become a new gold standard in glaucoma surgery via stepwise refinement.

7.
Acta Ophthalmol ; 101(6): 687-695, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36912796

RESUMO

PURPOSE: To assess the safety and performance of hyaluronic acid-based vitreous substitutes in phthitic eyes. METHODS: In this retrospective interventional study a total of 21 eyes from 21 patients with phthisis bulbi were treated at the Eye Clinic Sulzbach between August 2011 and June 2021. Patients who underwent a 23G pars plana vitrectomy received a vitreous substitute composed of (I) a non-crosslinked hyaluronic acid (Healon GV), (II) a crosslinked hyaluronic acid-based hydrogel (UVHA), or (III) silicone oil (SO-5000). Main outcome measures were the intraocular pressure (IOP), the visual acuity and the structural integrity of the retina and choroid assessed by optical coherence tomography. RESULTS: An increase in IOP ≥ 5 mmHg was achieved with SO-5000 in 5/8 eyes (6/10 interventions, 60.0%) for 36.4 ± 39.5 days, with Healon GV in 4/8 eyes (7/11 interventions, 63.6%) for 82.6 ± 92.5 days and with UVHA in 4/5 eyes (5/6 interventions, 83.3%) for 93.6 ± 92.5 days. Visual acuity increased in 5/21 eyes (23.8%), remained constant in 12/21 eyes (57.1%) and decreased in 4/21 eyes (19.0%). No enucleations were required during the mean follow-up time of 192 ± 182 days. The OCT images indicated the preservation of retinal structures, while choroidal folds were only diminished in UVHA eyes. CONCLUSIONS: Hyaluronic acid-based hydrogels are biocompatible vitreous substitutes in humans and can increase and stabilize IOP in patients with phthisis bulbi for about 3 months.


Assuntos
Ácido Hialurônico , Descolamento Retiniano , Humanos , Descolamento Retiniano/cirurgia , Estudos Retrospectivos , Retina , Vitrectomia/métodos , Cegueira
8.
Graefes Arch Clin Exp Ophthalmol ; 261(8): 2265-2280, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36976356

RESUMO

PURPOSE: We aimed to establish a rabbit model with retinal atrophy induced by an iatrogenic retinal pigment epithelium (RPE) removal, for future testing of the efficacy and safety of cell therapy strategies. METHODS: A localized detachment of the retina from the RPE/choroid layer was created in 18 pigmented rabbits. The RPE was removed by scraping with a custom-made extendable loop instrument. The resulting RPE wound was observed over a time course of 12 weeks with optical coherence tomography and angiography. After 4 days (group 1) and 12 weeks (group 2), histology was done and staining with hematoxylin and eosin, as well as immunofluorescence performed to further investigate the effects of debridement on the RPE and the overlying retina. RESULTS: Already after 4 days, we observed a closure of the RPE wound by proliferating RPE and microglia/macrophage cells forming a multilayered clump. This pattern continued over the observation time course of 12 weeks, whereby the inner and outer nuclear layer of the retina became atrophic. No neovascularization was observed in the angiograms or histology. The observed changes were limited to the site of the former RPE wound. CONCLUSIONS: Localized surgical RPE removal induced an adjacent progressive retinal atrophy. Altering the natural course of this model may serve as a basis to test RPE cell therapeutics.


Assuntos
Degeneração Retiniana , Epitélio Pigmentado da Retina , Animais , Coelhos , Epitélio Pigmentado da Retina/patologia , Retina/patologia , Corioide/patologia , Tomografia de Coerência Óptica/métodos , Atrofia , Angiofluoresceinografia/métodos
9.
J Glaucoma ; 32(5): 414-419, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-36795529

RESUMO

PRCIS: The Preserflo MicroShunt is an effective method to achieve a satisfying intraocular pressure (IOP) reduction in patients with complicated forms of glaucoma. PURPOSE: To evaluate the efficacy and safety of the Preserflo MicroShunt with mitomycin C in patients with complicated glaucoma. METHODS: This prospective interventional study included all patients that underwent Preserflo MicroShunt Implantation between April 2019 and January 2021 to treat severe and therapy refractory glaucoma. The patients either suffered from primary open angle glaucoma with already failed incisional glaucoma surgery or presented severe forms of secondary glaucoma (eg, after penetrating keratoplasty or globe penetrating injury). Primary endpoint was the IOP-lowering effect and the success rate after 12 months. Secondary endpoint was the occurrence of intraoperative or postoperative complications. Complete success was defined as reaching the target IOP (>6 mm Hg and <14 mm Hg) without additional IOP-lowering medication whereas qualified success was attained with the same IOP target regardless of the medication. RESULTS: A total of 40 eyes of 38 patients were enrolled. After 12 months 85.7% of the eyes achieved complete success with an average IOP of 10.5 ± 2.0 mm Hg, without the use of glaucoma eye drops. The average IOP reduction was 58.4% from baseline. In 5 cases (12.5%) failure occurred as revisional surgery was required. CONCLUSION: The Preserflo MicroShunt for refractory glaucoma cases achieved a high complete success rate without additional medication at 1 year. Revisional surgery was needed in some cases and long-term studies are needed.


Assuntos
Glaucoma de Ângulo Aberto , Glaucoma , Humanos , Glaucoma de Ângulo Aberto/cirurgia , Pressão Intraocular , Estudos Prospectivos , Mitomicina , Resultado do Tratamento
10.
Int Ophthalmol ; 43(7): 2237-2245, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36781625

RESUMO

PURPOSE: To determine the efficacy of different fragmentation patterns in femtosecond laser-assisted cataract surgery (FLACS) using Ziemer FEMTO LDV Z8. METHODS: We compared three different types of surgery: conventional cataract surgery (CCS), FLACS with conventional radial slices (named No-Spiderweb), and FLACS with a novel fragmentation pattern (radial slices combined with one or two rings) called "Spiderweb." Visual acuity (VA), nuclear opacity (NO) according to the Lens Opacities Classification System (LOCS lll), effective phacoemulsification time (EPT) and vacuum time were obtained for 845 eyes. RESULTS: Using FLACS (Spiderweb + No-Spiderweb), EPT was significantly reduced by 26% compared to CCS (FLACS: 2.46 ± 2.60 s; CCS: 3.34 ± 2.89 s; ΔM = - 0.88 s, p < .001). Furthermore, EPT as a function of progression of lens opacity was found to be not only lower in Spiderweb compared to CCS, but also in comparison with No-Spiderweb. At NO3, a significant reduction of 65% in EPT was observed by using Spiderweb compared to CCS (Spiderweb: 0.68 ± 1.23 s; CCS: 1.96 ± 1.53 s; ΔM = - 1.28 s, p <.001). Interestingly, EPT at NO3 was also significantly reduced by 57% in Spiderweb compared to No-Spiderweb (Spiderweb: 0.68 ± 1.23 s; No-Spiderweb: 1.57 ± 1 .59 s; ΔM = - 0.90 s, p <.001). The use of Spiderweb only marginally extends the vacuum time compared to No-Spiderweb by 11 s (Spiderweb: 209.13 ± 35.83 s; No-Spiderweb: 198.35 ± 36.84 s; p = .003) and the postoperative improved VA showed no significant difference among the different types of surgery (all ps ≥ .05). CONCLUSION: FLACS significantly reduces EPT compared to CCS. Furthermore, the novel Spiderweb pattern significantly reduces EPT in patients with a cataract of NO3 compared to CCS, but also to FLACS with the existing radial pattern (No-Spiderweb).


Assuntos
Extração de Catarata , Catarata , Terapia a Laser , Facoemulsificação , Humanos , Estudos Prospectivos , Lasers
11.
Am J Ophthalmol Case Rep ; 29: 101787, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36605184

RESUMO

Purpose: To report the case of a patient who presented with recurrent corneal erosions caused by an undetected plastic foreign body in the upper eyelid, which had remained asymptomatic for nearly 15 years following an ocular injury. Observations: A 39-year-old patient presented with recurrent corneal erosions and frontal headaches of unknown aetiology over the preceding eight months. The patient had previously been seen by twelve different ophthalmologists and had been treated over a 6-month period with a bandage contact lens, and therapeutic corneal scraping had been performed twice. However, the corneal erosion had repeatedly reappeared after removal of the bandage contact lens. On clinical examination prior to a planned phototherapeutic keratectomy, we extracted a 1.5 cm plastic foreign body, localised in the subtarsal area of the upper conjunctival fornix. Upon specific questioning, the patient denied any recent trauma, but reported a work-related accident with an accompanying eye injury 15 years before presentation. Conclusions and importance: Posttraumatic foreign bodies in the eye may remain asymptomatic for prolonged periods before giving rise to clinical signs such as recurrent corneal erosions. Hence, a thorough clinical examination with meticulous eyelid eversion should always be performed in such patients.

12.
Br J Ophthalmol ; 107(7): 941-945, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35443998

RESUMO

PURPOSE: To evaluate long-term intraocular temperature (IOT) variations in eyes with primary open-angle glaucoma (POAG) using an intraocular telemetric sensor. METHODS: This prospective, open-label, multicentre observational study analysed the IOT variations in 22 eyes of 22 patients with POAG. All enrolled patients underwent implantation of an intraocular pressure (IOP) sensor during cataract surgery. The telemetric system uses a built-in temperature sensor to control measured IOP for temperature. Each time a patient measures their IOP, both the IOP and IOT are recorded in the reader device. Patients were instructed to self-measure their IOP as often as desired, but at least four times daily. Recorded readings were retrieved and analysed using mixed effect models and pairwise comparisons using Bonferroni correction to assess the statistical significance of average IOT variations between each individual weekday and calendar month. RESULTS: The mean age of patients was 67.8±6.8 years and 36.4% were women. A total of 132 745 readings over 21 102 measurement-days were obtained. On average, IOT was significantly higher on Sundays (34.57°C; 95% CI 34.37 to 34.78) than on any other day of the week (p<0.001). Mean IOT on other weekdays ranged from 34.48°C to 34.51°C. Over the year, IOT followed a clear seasonal pattern, reaching its maximum in July (34.8°C; 95% CI 34.56 to 34.97) and its minimum in January (34.4°C; 95% CI 34.15 to 34.56; p<0.001). CONCLUSIONS: This study demonstrates the feasibility of continual and long-term measurement of IOT using intraocular sensors. The results show significant short-term and long-term fluctuations of IOT. Research is warranted to understand the impact of IOT variations on IOP, ocular perfusion and glaucoma progression.


Assuntos
Glaucoma de Ângulo Aberto , Glaucoma , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Glaucoma de Ângulo Aberto/diagnóstico , Estudos Prospectivos , Estações do Ano , Temperatura , Pressão Intraocular , Tonometria Ocular
13.
Br J Ophthalmol ; 107(4): 518-524, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-34772665

RESUMO

AIM: To investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS). METHODS: Prospective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor's safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tonometry (GAT). RESULTS: The eyes underwent canaloplasty (n=15) or deep sclerectomy (n=9) and achieved successful implantation of the sensor. No device migration, dislocation or serious device-related complications occurred. A total of 367 comparisons were included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 1.31 mm Hg (lower limit of agreement (LoA) 7.55 mm Hg; upper LoA -4.92 mm Hg). The maximum difference of 2.5 mm Hg ±3.96 (LoA 0.30-2.29) was reached on day 10 and continuously improved to an agreement of -0.15 mm Hg ±2.28 (LoA -1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of ±5 mm Hg improved from 78% (day 3) to 100% (6 months). CONCLUSIONS: After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring. TRIAL REGISTRATION NUMBER: NCT03756662.


Assuntos
Glaucoma de Ângulo Aberto , Pressão Intraocular , Humanos , Glaucoma de Ângulo Aberto/diagnóstico , Glaucoma de Ângulo Aberto/cirurgia , Estudos Prospectivos , Tonometria Ocular
14.
Retina ; 43(10): 1802-1806, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34050099

RESUMO

BACKGROUND/PURPOSE: To demonstrate possible complications of a new intraocular lens for sutureless secondary scleral implantation and modifications of the surgical technique to optimize outcomes. METHODS: A retrospective study of 16 eyes (16 patients) who underwent a secondary intraocular lens implantation using the Carlevale intraocular lens (Soleko, Italy) with two anchor haptics for intrascleral implantation (mean follow-up 2.2 months). RESULTS: The visual acuity did not improve statistically significantly postoperatively ( P = 0.601). Seven (44%) patients suffered from postoperative hypotonia (intraocular pressure <5 mmHg) during the first three postoperative days. CONCLUSION: Owing to the early postoperative hypotony, we decided to modify the surgical technique. We present several suggestions to optimize the technique and outcome such as positioning the sclerotomies at the 2 and 8 o'clock positions, using 27 G trocars alone and suturing the frown incisions using self-resorbing sutures.


Assuntos
Implante de Lente Intraocular , Lentes Intraoculares , Humanos , Implante de Lente Intraocular/métodos , Projetos Piloto , Estudos Retrospectivos , Complicações Pós-Operatórias/cirurgia , Esclera/cirurgia
15.
Eye (Lond) ; 37(8): 1553-1557, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-35864162

RESUMO

OBJECTIVES: To investigate the safety and effectiveness of pre-emptive vitrectomy in eyes with severe non-fibrotic proliferative diabetic retinopathy. METHODS: A multi-centre, retrospective, observational study. Pre-emptive vitrectomy was performed in non-fibrotic diabetic eyes with a visual acuity (VA) of 20/50 or better, where there was extensive persistent neovascularisation despite prior panretinal photocoagulation, and where the fellow eye had established sight loss despite vitrectomy for tractional complications. The primary outcome measure was the VA at last visit. RESULTS: Twenty patients were included. The mean age was 39 ± 14 years. Fifteen patients were Type 1 diabetic. The median baseline VA was 20/30 and remained stable at 20/28 at last visit (median follow-up period: 24 months). Eight eyes (40.0%) developed post-operative vitreous cavity haemorrhage; 4 of which required a vitreous cavity washout procedure. There were no post-operative retinal detachments. The index eye remained the significantly better eye at all time points bar one month post-surgery. Regression of retinopathy grading was observed in all eyes. CONCLUSION: In this pilot study, we found no sight loss with pre-emptive diabetic vitrectomy. Better eye status was maintained in this high-risk group. Further study with larger number of patients and longer-term follow-up is indicated.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Neovascularização Retiniana , Humanos , Adulto , Pessoa de Meia-Idade , Vitrectomia , Neovascularização Retiniana/cirurgia , Estudos Retrospectivos , Projetos Piloto , Retinopatia Diabética/complicações , Retinopatia Diabética/cirurgia , Fotocoagulação a Laser/métodos
16.
Ophthalmology ; 130(3): 304-312, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36202141

RESUMO

PURPOSE: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS). DESIGN: Prospective, multicenter, open-label, single-arm, interventional clinical trial. PARTICIPANTS: Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy). METHODS: An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months. MAIN OUTCOME MEASURES: Device position and adverse events. RESULTS: Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT. CONCLUSIONS: The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.


Assuntos
Glaucoma de Ângulo Aberto , Pressão Intraocular , Humanos , Estudos Prospectivos , Reprodutibilidade dos Testes , Tonometria Ocular
17.
Acta Ophthalmol ; 101(4): 422-432, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36457299

RESUMO

PURPOSE: Hydrogel-based vitreous substitutes have the potential to overcome the limitations of current clinically used endotamponades. With the goal of entering clinical trials, the present study aimed to (I) transfer the material synthesis of hyaluronic acid-based hydrogels into a routine, pharmaceutical-appropriate production and (II) evaluate the properties of the vitreous substitutes in terms of the current regulations for medical devices (MDR/ISO standards). METHODS: The multistep manufacturing process of the vitreous substitutes, including the modification of hyaluronic acid with glycidyl methacrylate, photocopolymerization with N-vinylpyrrolidone, and successive hydrogel purification, was developed under laboratory conditions, characterized using 1 H-NMR, FT-IR and UV/Vis spectroscopies and HPLC, and transferred towards a pharmaceutical production environment considering GMP standards. The optical and viscoelastic characteristics of the hyaluronic acid-based hydrogels were compared with those of extracted human vitreous and silicone oil. The effect of the hydrogels on the metabolic activity, proliferation and apoptosis of fibroblast (MRC-5, BJ, L929), retinal pigment epithelial (ARPE-19, hiPSC-derived RPE) and photoreceptor cells (661W) was studied as well as their mucosal tolerance via a HET-CAM assay. RESULTS: Hyaluronic acid-based hydrogels having a suitable purity, sterility, high transparency (>90%), appropriate refractive index (1.3365) and viscoelasticity (G' > G″) were prepared in a standardized manner under controlled process conditions. The metabolic activity, proliferation and apoptosis of various cell types as well as egg choroid were unaffected by the hyaluronic acid-based vitreous substitutes, demonstrating their biocompatibility. CONCLUSIONS: The present study demonstrates the successful transferability of the crucial synthesis steps of hyaluronic acid-based hydrogels into a routine, GMP-compliant production process while achieving the optical and viscoelastic properties, biocompatibility and purity required for their clinical use as vitreous substitutes.


Assuntos
Ácido Hialurônico , Corpo Vítreo , Humanos , Corpo Vítreo/cirurgia , Ácido Hialurônico/farmacologia , Espectroscopia de Infravermelho com Transformada de Fourier , Hidrogéis/química , Hidrogéis/uso terapêutico
19.
Transl Vis Sci Technol ; 11(9): 14, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-36125790

RESUMO

Vitreous substitutes are traditionally used to stabilize the retina after vitrectomy. In recent years, various approaches have been developed for using the vitreous substitute not only as a tamponade but also as a drug release system to tackle ocular diseases. This review provides an overview of the requirements for vitreous substitutes and discusses the current clinically applied as well as novel polymer-based vitreous substitutes as drug delivery systems, including their release mechanisms, efficiencies, challenges, and future perspectives.


Assuntos
Vitrectomia , Corpo Vítreo , Liberação Controlada de Fármacos , Polímeros , Retina , Corpo Vítreo/cirurgia
20.
Am J Ophthalmol Case Rep ; 28: 101688, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36046519

RESUMO

Purpose: Presenting a simple technique using an inversely implanted contact lens to create a temporary diaphragm to assist DMEK surgery in aphakic, partially aniridic and vitrectomized eyes. Observations: The postoperative course was without pressure abnormalities and the anterior chamber remained deep. The cornea completely cleared within 3 weeks and remained clear after removal of the contact lens showing a corneal thickness of 544 µm and an intact endothelial cell pattern on endothelial cell microscopy after 3 months. Conclusion and Importance: The inversely implanted contact lens provides an easily accessible temporary diaphragm, making DMEK surgery a safer procedure even in complex eyes without an adequate posterior barrier.

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