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

NCT06189326 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-03

No results posted yet for this study

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

Conditions

  • Congenital Glaucoma

Interventions

PROCEDURE

non-penetrating deep sclerectomy

Non-penetrating deep sclerectomy (NPDS) is a non-perforating filtration procedure used for the surgical treatment of medically uncontrolled open angle glaucoma. This procedure was developed in an attempt to avoid many of the postoperative complications of trabeculectomy

PROCEDURE

primary combined trabeculotomy-trabeculectomy

Combining trabeculotomy with trabeculectomy is one of the preferred surgical options, which showed favorable results in congenital glaucoma, and is advised mainly for treating moderate to severe forms of the disease, as the procedure provides dual pathways for aqueous drainage

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-12-01
Completion
2024-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06189326 on ClinicalTrials.gov