Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

Study Overview
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Brief Summary
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A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma.

Detailed Description
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Patients were randomized into two groups: group A : patients will undergo two site phacoemulfication combined with trabeculectomy Group B with Phacoemulsification combined with ab-externo trabeculotomy. Preoperative assessments including full ophthalmic examination, anterior segment Optical Coherence Tomography (OCT) of the angle , endothelial cell count , visual fiend Perimetry and Biometry. Patients were followed up: first day, first week and every two months for 6 month. We will compare adverse effects and outcomes in both groups.

Official Title
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Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma

Conditions
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Ophthalmopathy, Glaucoma, Glaucoma, Angle-Closure

Intervention / Treatment
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* Procedure: Phacoemulsification combined with trabeculectomy
* Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic angle closure glaucoma, with or without peripheral anterior synechiae, age more than 18 Exclusion Criteria: Patient unable for follow up Patients with corneal or retinal disease that affects visual outcome of surgery Patients with previous glaucoma procedure in the eye of study

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phacoemulsification combined with trabeculectomy<br>Patients will undergo Two site phacoemulsification combined with trabeculectomy with Mitomycin C | Procedure: Phacoemulsification combined with trabeculectomy<br>* Patients with chronic angle closure glaucoma assigned to this group will have fornex based trabeculectomy at superior limbus and then phacoemulsification via temporal incision<br>|
| Active Comparator: Phacoemulsificaiton combined with ab-externo trabeculotomy<br>Patients will undergo two phacoemulsification combined with deep sclerectomy and ab-externo trabeculotomy | Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy<br>* Patients with chronic angle closure glaucoma assigned to this group will have Deep Sclerectomy with ab externo trabeculotomy at superior limbus and then phacoemulsification via temporal incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Success | Reduction of IOP more than 30% on no glaucoma drops | 1,3,6 months | 
| Visual outcome | Uncorrected visual acuity by Snellen's chart | 1,3,6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | all intraoperative and postoperative adverse events witt be recorded | 1 week, 1 month, 3 months, 6 months |