Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy for Primary Congenital Glaucoma

NCT07701278 | Completed

• 1 other identifier: PCG-TDS-2022
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Primary congenital glaucoma (PCG) is a vision-threatening disorder of childhood characterized by elevated intraocular pressure (IOP) resulting from developmental abnormalities of the anterior chamber angle. Early surgical intervention is the standard treatment to preserve visual function and prevent progressive optic nerve damage. This retrospective interventional case series evaluated the safety and efficacy of subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification) in children with PCG. Medical records of patients who underwent surgery between January 2022 and June 2025 at Benha University Hospital were reviewed. The primary outcome was reduction in intraocular pressure. Secondary outcomes included surgical success rates, reduction in antiglaucoma medication use, changes in corneal clarity and optic nerve status, postoperative complications, and the need for additional glaucoma surgery following a minimum follow-up of 12 months.

Conditions

Primary Congenital Glaucoma; Pediatric Glaucoma; Intraocular Pressure

Keywords

Primary congenital glaucoma; Pediatric glaucoma; Childhood glaucoma; Trabeculectomy; Intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP)

  Mean change in intraocular pressure (mmHg), measured by applanation tonometry or under anesthesia when necessary, from baseline to 12 months after subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy.

  Baseline and 12 months

Secondary Outcomes (1)

• Complete Surgical Success Rate

  Baseline to12 months

Study Arms (1)

Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy

EXPERIMENTAL

All participants underwent subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification) for the treatment of primary congenital glaucoma. Surgical outcomes were assessed retrospectively after a minimum postoperative follow-up of 12 months.

Procedure: Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep Sclerectomy

Interventions

Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep Sclerectomy PROCEDURE

Subscleral trabeculectomy was performed beneath a superficial scleral flap, followed by creation of an inverted T-shaped deep sclerectomy (El-Habbak modification). The modification consisted of a vertical deep scleral channel extending toward the limbus and a posterior horizontal extension to create an enlarged intrascleral filtration reservoir. Peripheral iridectomy was then performed, and the scleral flap and conjunctiva were closed in the standard fashion. The procedure was intended to enhance aqueous humor outflow while maintaining controlled filtration and reducing postoperative fibrosis.

Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy

Eligibility Criteria

• Age: 0 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of primary congenital glaucoma.
• Age 3 years or younger at the time of diagnosis.
• Underwent subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification).
• Availability of complete medical records.
• Minimum postoperative follow-up of 12 months.

You may not qualify if:

• Secondary childhood glaucomas.
• Associated ocular anomalies.
• Previous glaucoma surgery.
• Incomplete clinical records.
• Postoperative follow-up of less than 12 months.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

MeSH Terms

Conditions

Hydrophthalmos

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Glaucoma, Open-Angle; Glaucoma; Ocular Hypertension; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Model Details: All enrolled patients underwent subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification). Surgical outcomes were evaluated retrospectively following a minimum postoperative follow-up of 12 months.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: January 1, 2022
• Primary Completion: June 1, 2026
• Study Completion: June 15, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

EG (1)