Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma

Study Overview
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Brief Summary
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The aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma.

Detailed Description
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End-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. A common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. This study specifically aims to compare the intraocular pressure (IOP) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.The hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.

Official Title
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A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma

Conditions
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Advanced Glaucoma, Refractory Glaucoma

Intervention / Treatment
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* Procedure: Micropulse Transscleral Cyclophotocoagulation
* Procedure: Conventional Transscleral Cyclophotocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: · More than 21 years old Advanced glaucoma refractory to maximum tolerated medical and surgical treatment Visual acuity worse than 6/60 Poor candidates for additional filtration surgery Exclusion Criteria: · Any eye surgery done within 2 months of enrolment Any ocular infection or inflammation Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Micropulse Transscleral Cyclophotocoagulation|nan|
|Procedure: Conventional Transscleral Cyclophotocoagulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with complications, such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced glaucoma, Refractory glaucoma, Cyclophotocoagulation, Transscleral cyclophotocoagulation, Micropulse transscleral cyclophotocoagulation