Primary Congenital GlaucomaTDS-PCGNCT07701278
Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy for Primary Congenital Glaucoma
A study testing Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep Sclerectomy in people with Primary Congenital Glaucoma and Pediatric Glaucoma, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 3 years
- Conditions the study is for
- Primary Congenital Glaucoma, Pediatric Glaucoma, Intraocular Pressure
- What is being tested?
- Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep Sclerectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Secondary childhood glaucomas.
- Associated ocular anomalies.
- Previous glaucoma surgery.
- Incomplete clinical records.
- Postoperative follow-up of less than 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Subscleral Trabeculectomy Combined With an Inverted T-Shaped Deep Sclerectomy for the Treatment of 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.
Read the detailed description
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.
- Being tested
- Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep Sclerectomy
- Keywords
- Primary congenital glaucoma, Pediatric glaucoma, Childhood glaucoma, Trabeculectomy, Intraocular pressure
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep SclerectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep Sclerectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (1)
Complete Surgical Success Rate
Proportion of eyes achieving an intraocular pressure between 6 and 21 mmHg with at least a 30% reduction from baseline without antiglaucoma medications.
Measured: Baseline to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jan 2022
- Primary completion1 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Congenital GlaucomaStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701278
- Sponsor's protocol ID
- PCG-TDS-2022
- Acronym
- TDS-PCG
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Subscleral Trabeculectomy Combined With an Inverted T-Shaped Deep Sclerectomy for the Treatment of Primary Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT07701278
- Acronym / sponsor ID
- TDS-PCG / PCG-TDS-2022
- Keywords
- Primary congenital glaucoma, Pediatric glaucoma, Childhood glaucoma, Trabeculectomy, Intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy | Experimental | Procedure: Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep SclerectomyAll 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. |
Who may qualify
- Ages
- 0 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Secondary childhood glaucomas.
- Associated ocular anomalies.
- Previous glaucoma surgery.
- Incomplete clinical records.
- Postoperative follow-up of less than 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep SclerectomySubscleral 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. | Procedure or surgery | Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy |
Primary outcome
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.
1 secondary outcome
Complete Surgical Success Rate
Time frame: Baseline to12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subscleral Trabeculectomy Combined With Inverted T-Shaped Deep Sclerectomy in people with Primary Congenital Glaucoma and Pediatric Glaucoma, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (IOP) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.