Comparison of Effect of Postoperative Cyclosporine A 2% Ophthalmic Emulsion and Betamethasone Eye Drop on Surgical Success of Trabeculectomy Procedure

Study Overview
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Brief Summary
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Glaucoma is one of the leading causes of blindness worldwide and trabeculectomy is the most commonly performed operation to slow-down the disease progression. In this study, we compare the effect of topical cyclosporine A and betamethasone eye drops on the postoperative course and surgical success of trabeculectomy.

Detailed Description
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Trabeculectomy is still the most popular filtering surgery for glaucomatous patients. In this type of surgery, postoperative care and management is highly important for surgical success. A principle component of postoperative regimen is anti-inflammatory medications. However, corticosteroid eye drops, the most frequently used agents, have some side effects, including raising intraocular pressure. Cyclosporine A could be an interesting alternative, because not only it has acceptable anti-inflammatory effect and could reduce some ocular surface problems, but also it has minimal direct effect on intraocular pressure. In this study, we will compare the effect of topical cyclosporine A and betamethasone on surgical outcome and postoperative course of trabeculectomy patients. The study is a prospective study to compare the effect of topical betamethasone and cyclosporine A on postoperative findings of glaucoma patients, undergoing trabeculectomy surgery. In this study, trabeculectomy patients, who fulfill the study criteria, will be randomized to either study group and follow-up visits will be done in a masked fashion. In each visit, a detailed history taking and eye examination will be done by an examiner unaware of study group. A third party would do data control for patient safety. At the conclusion of the study, the data of the two groups would be compared. All human research ethical codes are strictly respected and the Ethical Committee of the University has an ongoing inspection on all study steps. We hypothesize that cyclosporine A could provide better inflammation and intraocular pressure control and may enhance surgical success rate. However, our null hypothesis is that the result in study groups will not differ statistically significantly.

Official Title
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Comparison of Effect of Cyclosporine Ophthalmic Emulsion 2% and Betamethasone Eye Drop on Intraocular Pressure, Conjunctival Hyperemia and Subjective Dry Eye Symptoms Following Trabeculectomy in Open Angle Glaucoma Patients

Conditions
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Glaucoma, Open Angle

Intervention / Treatment
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* Drug: Cyclosporine
* Drug: Betamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: POAG patient with insufficient IOP control on maximal tolerable medical therapy (MTMT), undergoing primary trabeculectomy with MMC augmentation. Exclusion Criteria: Age <20 years History of previous ocular surgery in the same eye; Candidate for combined surgery; Pregnancy; Breast feeding; Monocular subject; Allergy to any topical antiglaucoma medication or cyclosporine

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclosporine<br>In the first postoperative day following a standard, fornix-based trabeculectomy, ophthalmic emulsion of Cyclosporine A, 2%, every 4 hours for the first postoperative week and every 6 hours for the next 3 weeks will be prescribed for the patients. | Drug: Cyclosporine<br>* In study arm, ophthalmic emulsion of cyclosporine A 2% will be prescribed in postoperative phase.<br>* Other names: Cyclosporine A (Sina Darou);|
| Active Comparator: Betamethasone<br>In the first postoperative day following a standard, fornix-based trabeculectomy, betamethasone eye drop, every 4 hours for the first postoperative week and every 6 hours for the next 3 weeks will be prescribed for the patients. | Drug: Betamethasone<br>* In control arm, betamethasone eye drop will be prescribed in postoperative period.<br>* Other names: Betasonate (Sina Darou);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Each month following trabeculectomy, intraocular pressure will be measured using Goldmann Applanation Tonometer. | Up to 6 months after surgery | 
| Bleb morphology | Bleb morphology according to IBAGS grading system, based on clinical examination and slit-lamp photography. | Up to 6 months after surgery | 
| Subjective dry eye symptoms | Subjective symptoms of dry eye, reported by patients, and gathered using a standardized questionnaire. | Up to 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical success rate | The surgical success rate of trabeculectomy in each study arm. | 6 month after surgery | 
| Complications | Any complication observed during study period, reported by patient or examiner. | Up to 6 months after surgery | 
| Visual acuity | LogMAR visual acuity, measured on every postoperative visit. | Up to 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, trabeculectomy, cyclosporine, betamethasone