Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma

Study Overview
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Brief Summary
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The aim of this study is to assess the results of subliminal subthreshold transscleral diode cyclophotocoagulation in refractory glaucoma using the standard technique of 360 degree application and to compare the outcome with a modified technique both in terms of efficacy and safety.

Detailed Description
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Refractory glaucoma is glaucoma that doesn't respond favorably to surgical and/or medical treatment to lower intraocular pressure. It can include primary open angle glaucoma, primary angle closure glaucoma, neovascular glaucoma or silicone oil-induced glaucoma. Cyclophotocoagulation (CPC) is a form of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. Transscleral cyclophotocoagulation using a continuous diode laser has been a treatment option in advanced glaucoma cases with s¬¬uboptimal IOP control, for a long time. High treatment energy used by diode laser cyclophotocoagulation was argued to be associated with increased frequency of serious complications such as vision loss, hypotony, and phthisis. These concerns necessitate modulation of the parameters of laser treatment used. Micropulse transscleral cyclophotocoagulation (MP-TSCPC), which is a variation of conventional continuous-wave CPC, has emerged as an attractive alternative for the treatment of many types of glaucoma. It breaks the continuous wave laser into multiple short and repetitive pulses that allow the tissue to cool down between applications, thus reducing thermal damage. This strategy delivers very short energy pulses followed by rest periods, which is known as duty cycle and is defined as the ratio of time that a laser is delivering energy vs resting (ON/OFF). For this procedure, an infrared diode laser is used to stimulate the ciliary body structures and the uveoscleral pathway. This way it reduces the production of the aqueous humour and facilitates the uveoscleral outflow, with IOP reduction as a final effect. Despite promising results, only few clinical studies are published on MP-TSCPC and most of them are retrospective studies refer to patients having previous continuous wave transscleral cyclophotocoagulation. Moreover, Several parameters and protocols have been studied in other reports in an attempt to refine the standard technique aiming to improve the outcomes without increasing the adverse effects.

Official Title
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Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma

Conditions
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Refractory Glaucoma

Intervention / Treatment
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* Device: 360 degrees subthreshold diode laser cyclophotocoagulation
* Device: 180 degrees subthreshold diode laser cyclophotocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with refractory glaucoma (IOP > 21 mmHg unresponsive to maximally tolerated antiglaucoma medications, previously failed surgical treatment, or both) Exclusion Criteria: Ocular inflammation. Ocular infection. Recent ocular surgery in the study eye in the 2 months prior to enrolment.
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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A the standard technique<br>cyclophotocoagulation is applied along the upper and lower hemispheres over pars plana -3 mm behind the limbus | Device: 360 degrees subthreshold diode laser cyclophotocoagulation<br>* cyclophotocoagulation is applied along 360 degrees over pars plana<br>|
| Active Comparator: Group B a modified technique<br>cyclophotocoagulation is applied over one hemisphere only (180 degrees) along pars plana-3 mm behind the limbus- followed by a second application over pars plicata-1.2 mm behind the limbus- along the same hemisphere (ie, in a double arc fashion). | Device: 180 degrees subthreshold diode laser cyclophotocoagulation<br>* cyclophotocoagulation is applied over one hemisphere only along 180 degrees in a double arc fashion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP reduction success rate | Success rate is defined as achieving an IOP between 5 and 21 mmHg or at least a 20% reduction in IOP at the final follow up with or without IOP lowering medications | 6 months |