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Safety and Efficacy of Second Ahmed Valve Implant in Refractory Glaucoma.

ABSTRACT: BACKGROUND:Refractory glaucoma still represents a challenge for ophthalmologists to manage intraocular pressure. The present study aimed to evaluate long term efficacy and safety of a second Ahmed valve implantation after the failure of a first implant in patients with refractory glaucoma and elevated intraocular pressure (IOP). METHODS:Retrospective, multicenter non-comparative case series. Twenty-eight patients were retrospectively recruited between January 2011 and December 2017. Demographic data, glaucoma type, visual acuity, intraocular pressure, medical therapy, and complications were registered. Three criteria of success were established: Type 1 surgical success: IOP ? 15 mmHg and a reduction of IOP ? 40% from baseline; Type 2 surgical success: IOP ? 18 mmHg and a reduction of IOP ? 30% from baseline; and Type 3 surgical success: IOP ? 21 mmHg and a reduction of IOP ? 20% from baseline. Surgical failure has been established as IOP less than 5 mmHg or over 21 mmHg and less than a 20% reduction of IOP from baseline despite medications in two consecutive visits, light perception loss referable to glaucoma, and the necessity for further glaucoma surgery. Failure was observed in six (21%) patients. (3) Results: Mean IOP and mean glaucoma medication number significantly reduced from baseline after the second implantation, and the surgical success rate at 72 months ranged from 10% to 78% based on the different criteria of success. Failure was observed in six (21%) patients. CONCLUSIONS:This study confirmed the safety and efficacy of a second Ahmed valve implantation in patients with refractory glaucoma and elevated IOP at baseline.

SUBMITTER: Posarelli C

PROVIDER: S-EPMC7408983 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Safety and Efficacy of Second Ahmed Valve Implant in Refractory Glaucoma.

Posarelli Chiara C Toro Mario Damiano MD Rejdak Robert R Żarnowski Tomasz T Pożarowska Dorota D Longo Antonio A Miccoli Mario M Nardi Marco M Figus Michele M

Journal of clinical medicine 20200629 7

<h4>Background</h4>Refractory glaucoma still represents a challenge for ophthalmologists to manage intraocular pressure. The present study aimed to evaluate long term efficacy and safety of a second Ahmed valve implantation after the failure of a first implant in patients with refractory glaucoma and elevated intraocular pressure (IOP).<h4>Methods</h4>Retrospective, multicenter non-comparative case series. Twenty-eight patients were retrospectively recruited between January 2011 and December 201 ...[more]

PMID: 32610602

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Project description:AimTo compare a range of clinical outcome variables (intraocular pressure, glaucoma medications, visual acuity, and complications) between two Ahmed glaucoma valve (AGV) models (S2 and FP7).MethodsThis was a prospective and randomized clinical trial. Fifty-six patients with refractory glaucoma were randomly assigned to be implanted with either a polypropylene (S2) or silicone (FP7) Ahmed glaucoma valve. The primary outcome measure was a surgical success, defined as an IOP ≤ 16 mm Hg (without medication), and guarded success, defined as a controlled IOP ≤ 16 mmHg (with medication). Failure was defined as when the IOP lay outside of the successful range on two consecutive visits (>16 mmHg, despite medication).ResultsMean follow-up period was 398.42 ± 12.34 days (range, 380-420 days) for the S2 group and 401.75 ± 9.78 days (range, 385-420 days) for the FP7 group; these values were not significantly different (P = 0.27). After 12 months of follow-up, the baseline IOP (45.42 mmHg) fell significantly to 16.14 mmHg in the S2 group (p < 0.000); there was also a significant reduction in IOP in the FP7 group (from 44.17 mmHg to 15.18 mmHg in FP7 group, p < 0.000). At the last follow-up examination, the mean IOP in the S2 group was 16.14 ± 3.18 mmHg, while that of the FP7 group was 15.18 ± 2.75 mmHg; there was no significant difference between the two groups with this respect (p = 0.23). The mean number of medications used by patients in the S2 and FP7 groups was 2.92 ± 1.27 and 2.75 ± 1.43, respectively; there was no significant difference between the two groups with this respect (p = 0.32). There was no significant difference between the FP7 and S2 groups with regard to their relative success rate (17.89% [5/28] versus 10.7% [3/28], respectively; p = 0.38).ConclusionOur data show that the S2 and FP7 models of AGV were both effective in lowering IOP and reducing the need for glaucoma medications. Although these two AGV models had similar dimensions, they were constructed from different materials. However, there were no significant clinical differences between the S2 and FP7 AGV groups after 12 months of follow-up. Furthermore, our data indicate that bleb encapsulation was the primary factor responsible for failure rate and the need for glaucoma medication in both the S2 and FP7 groups. Our analysis further indicates that the S2 and FP7 Ahmed valves are associated with a high risk of failure when considered as a first-line therapy for cases experiencing trabeculectomy.Clinical trial registrationNCT04214847.

Dataset Information

Safety and Efficacy of Second Ahmed Valve Implant in Refractory Glaucoma.

Publications

Safety and Efficacy of Second Ahmed Valve Implant in Refractory Glaucoma.

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