Inverted T Trabeculectomy Primary Congenital Glaucoma (Inverte T trab)

Inverted T Trabeculectomy for Primary Congenital Glaucoma, A Novel Technique

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma, Congenital, Surgical Treatment
• Intervention / Treatment: Procedure: Inverted T trabeculectomy

Detailed Description

This study included patients from the glaucoma clinic at Benha University Hospital between April 2015 and October 2017. All were diagnosed with PCG based on an intraocular pressure (IOP) measurement of 21 mmHg or more at birth or shortly after, up to the age of 12 months. Patients with previous intraocular or conjunctival surgery, those with significant ocular trauma, and those with congenital glaucoma associated with other ocular anomalies that would affect IOP were excluded from the study.

The procedure principles and potential complications were discussed with the children's parents or legal guardians, and they gave written informed consent before surgery. This study was approved by the Benha Faculty of Medicine's ethical committee (Approval number RC 9-1-2025) and conducted according to Helsinki's declaration.

All patients underwent complete ophthalmic examination under general anaesthesia before surgery. IOP was measured 5 minutes after injecting intravenous Ketamine 1mg/kg for induction of anaesthesia. We used a Perkins tonometer (Haag-Streit, UK) to measure the IOP before applying the eyelid speculum. Corneal clarity was assessed under a surgical microscope, the corneal diameter was recorded using a surgical caliber, and fundus examination was done by indirect ophthalmoscope. A surgical Swan Jacob gonioprism assessed the anterior chamber angle when the cornea was clear enough to achieve a good view.

All surgeries were performed under general anaesthesia by the same surgeon (AEH).

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qualubia
    • Banhā, Qualubia, Egypt, 13111
      • Benha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• PCG based on an intraocular pressure (IOP) measurement of 21 mmHg or more at birth or shortly after, up to the age of 12 months

Exclusion Criteria:

• Patients with previous intraocular or conjunctival surgery, those with significant ocular trauma, and those with congenital glaucoma associated with other ocular anomalies that would affect IOP were excluded from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Primary congenital glaucoma surgey; Compare the Novel inverted T technique to the classic trabeculectomy in treatment of primary congenital glaucoma

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post op IOP	IOP lower than 21 mmHg or > 20% reduction from the baseline IOP in at least two consecutive follow-up visits without IOP-lowering medications and without vision-threatening complications	18 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Glaucoma, Open-Angle; Glaucoma; Hydrophthalmos
• Other Study ID Numbers: Inverted T trab PCG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data supporting this study's findings are available from the corresponding author, upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No