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

Al-Azhar University

Status: Active, not recruiting

Conditions: Congenital Glaucoma

Treatments: Procedure: primary combined trabeculotomy-trabeculectomy; Procedure: non-penetrating deep sclerectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06189326

primary congenital glaucoma

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 1 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

non-penetrating deep sclerectomy

Active Comparator group

Treatment:

Procedure: non-penetrating deep sclerectomy

primary combined trabeculotomy-trabeculectomy

Active Comparator group

Treatment:

Procedure: primary combined trabeculotomy-trabeculectomy