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Completed

NCT Number: NCT07701278

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

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.

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Key information

Age range

0 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Benha, 13111, Egypt

About this study

Primary congenital glaucoma (PCG) is a rare developmental glaucoma caused by trabeculodysgenesis, leading to impaired aqueous humor outflow, elevated intraocular pressure (IOP), corneal enlargement and edema, optic nerve damage, and irreversible visual loss if untreated. Surgical management remains the primary treatment because medical therapy alone is generally insufficient for long-term IOP control.

Trabeculectomy is an established filtration procedure for pediatric glaucoma; however, its long-term success may be limited by aggressive postoperative wound healing and subconjunctival fibrosis. Deep sclerectomy and other non-penetrating glaucoma procedures were developed to improve aqueous drainage while reducing complications associated with conventional penetrating filtration surgery.

This study evaluated a modified surgical technique consisting of subscleral trabeculectomy combined with an inverted T-shaped deep sclerectomy (El-Habbak modification). The modification involves creating a vertical deep scleral channel directed toward the limbus together with a posterior horizontal extension, forming an enlarged intrascleral filtration reservoir intended to facilitate aqueous humor drainage while maintaining controlled filtration.

This was a retrospective interventional case series conducted at the Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt. Medical records of children with primary congenital glaucoma who underwent this surgical procedure between January 2022 and June 2025 and completed at least 12 months of postoperative follow-up were reviewed.

The primary objective was to evaluate postoperative reduction in intraocular pressure. Secondary objectives included assessment of complete and qualified surgical success, reduction in the number of antiglaucoma medications, improvement in corneal clarity, changes in cup-to-disc ratio, postoperative complications, and the need for additional glaucoma surgery.

The study was performed in accordance with the Declaration of Helsinki and received approval from the Institutional Review Board of the Faculty of Medicine, Benha University. All data were analyzed retrospectively after completion of patient follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Intraocular Pressure (IOP)

    Time frame: Baseline and 12 months

    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.

Secondary outcomes

  1. Complete Surgical Success Rate

    Time frame: Baseline to12 months

    Proportion of eyes achieving an intraocular pressure between 6 and 21 mmHg with at least a 30% reduction from baseline without antiglaucoma medications.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Safety and Efficacy of Subscleral Trabeculectomy Combined With an Inverted T-Shaped Deep Sclerectomy for the Treatment of Primary Congenital Glaucoma

Acronym: TDS-PCG

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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