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Inverted T Trabeculectomy Primary Congenital Glaucoma

NCT06837610 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-02-20

No results posted yet for this study

Summary

This study aims to evaluate the safety and efficacy of novel Inverted T trabeculectomy in Primary Congenital Glaucoma (PCG). It enrolled 50 eyes of 25 children with PCG. The mean age at the time of surgery was 12±11 months, and the mean presenting IOP was 40±4 mmHg. Patients with previous intra-ocular or conjunctival surgery, those who had significant ocular trauma, and patients with congenital glaucoma associated with ocular anomalies diseases were excluded from the study. All patients had Inverted T trabeculectomy under general anesthesia. The IOP in the operated eyes was followed up for 36 months.

Conditions

  • Glaucoma, Congenital, Surgical Treatment

Interventions

PROCEDURE

Inverted T trabeculectomy

* Fornix-based conjunctival incision along with the opening of Tenon's capsule and dissection along the area of the potential bleb. * A 4 x 4 mm limbal-based scleral flap was fashioned using a crescent knife. Dissection was carried out up to the clear cornea. * A longitudinal tunnel was made through the scleral bed, starting from the limbus and extending 1 mm beyond the end of the scleral flap. Afterwards, the horizontal limb of the Inverted T was created. (Figure 2) * A paracentesis was made using an MVR blade. * The anterior chamber was entered using an MVR blade. Kelly's punch was used to excise 1.5 x 1.5 mm of scleral bed at the limbus at the base of the vertical limb of the figure (T), and then a peripheral iridectomy was performed using Vannas scissors. * The scleral flap was then closed using two fixed 10/0 Nylon sutures, one at each corner.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-07-01
Completion
2025-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06837610 on ClinicalTrials.gov