Non-penetrating Deep Sclerectomy Versus Trabeculotomy- Trabeculectomy Operation in Treatment of Primary Congenital Glaucoma

Not Applicable

Active, not recruiting

• Conditions: Congenital Glaucoma
• Interventions: Procedure: primary combined trabeculotomy-trabeculectomy; Procedure: non-penetrating deep sclerectomy

• Registration Number: NCT06189326
• Lead Sponsor: Al-Azhar University

Brief Summary

The high success rate of the non-penetrating deep sclerectomy (NPDS) procedure in adult glaucomatous patients motivated some glaucoma specialists to try it as an alternative procedure in childhood PCG. In deep sclerectomy, the surgeon fashions a partial-thickness scleral flap and excises the outer parts of both Schlemm's canal and trabecular meshwork without opening the eye, leaving a thin trabeculo-descemetic membrane. This membrane will guard against early postoperative hypotony due to the non-penetrating nature of the procedure.

The aim of this study is to assess the safety and efficacy outcomes of non-penetrating deep sclerectomy versus combined trabeculotomy-trabeculectomy in the treatment of congenital primary glaucoma

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients with PCG younger than 6 years old with a HCD between 12-14 mm ware

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Exclusion Criteria

• patients with anterior segment anomalies,
• secondary glaucoma
• previous anterior segment surgeries
• patients more than 6 years old

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
primary combined trabeculotomy-trabeculectomy	primary combined trabeculotomy-trabeculectomy	-
non-penetrating deep sclerectomy	non-penetrating deep sclerectomy	-

Primary Outcome Measures

Name	Time	Method
Intra Occular Pressure	Post 6 month	Intraocular pressure (IOP) is the fluid pressure of the eye. As pressure is a measure of force per area, IOP is a measurement involving the magnitude of the force exerted by the aqueous humor on the internal surface area of the anterior eye.; It is measured by applanation tonometer its unite is mmHg

Trial Locations

Locations (1)

Ehab tharwat; 🇪🇬 Damieta, New Damietta, Egypt