Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

Not Applicable

Completed

• Conditions: Ophthalmopathy; Glaucoma, Angle-Closure; Glaucoma
• Interventions: Procedure: Phacoemulsification combined with trabeculectomy; Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy

• Registration Number: NCT04683055
• Lead Sponsor: Assiut University

Brief Summary

A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma.

Detailed Description

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.

Study Timeline

• Study Start: 2020-10-28
• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2020-12-20
• Study First Posted: 2020-12-24
• Primary Completion: 2020-12-31
• Study Completion: 2021-05-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phacoemulsification combined with trabeculectomy	Phacoemulsification combined with trabeculectomy	Patients will undergo Two site phacoemulsification combined with trabeculectomy with Mitomycin C
Phacoemulsificaiton combined with ab-externo trabeculotomy	Phacoemulsificaiton combined with ab-externo trabeculotomy	Patients will undergo two phacoemulsification combined with deep sclerectomy and ab-externo trabeculotomy

Primary Outcome Measures

Name	Time	Method
Absolute Success	1,3,6 months	Reduction of IOP more than 30% on no glaucoma drops
Visual outcome	1,3,6 month	Uncorrected visual acuity by Snellen's chart

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 week, 1 month, 3 months, 6 months	all intraoperative and postoperative adverse events witt be recorded

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt