Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy for Primary Congenital Glaucoma (TDS-PCG)
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Benha
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Banhā, Benha, Egipt, 13111
- Benha University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Subscleral Trabeculectomy With Inverted T-Shaped Deep Sclerectomy
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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Intraocular Pressure (IOP)
Ramy czasowe: Baseline and 12 months
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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.
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Baseline and 12 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Complete Surgical Success Rate
Ramy czasowe: Baseline to12 months
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Proportion of eyes achieving an intraocular pressure between 6 and 21 mmHg with at least a 30% reduction from baseline without antiglaucoma medications.
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Baseline to12 months
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PCG-TDS-2022
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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