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

NCT ID: NCT06189326

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-02-01

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

Conditions

Congenital Glaucoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

non-penetrating deep sclerectomy

Group Type: ACTIVE_COMPARATOR

non-penetrating deep sclerectomy

Intervention Type: PROCEDURE

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

primary combined trabeculotomy-trabeculectomy

Group Type: ACTIVE_COMPARATOR

primary combined trabeculotomy-trabeculectomy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ehab Tharwat

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ehab tharwat

Damietta, New Damietta, Egypt

Countries

Egypt

Other Identifiers

primary congenital glaucoma

Identifier Type: -

Identifier Source: org_study_id