Inverted T Trabeculectomy Primary Congenital Glaucoma

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.

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Key information

Conditions

Glaucoma, Congenital, Surgical Treatment Eye Diseases Glaucoma Ocular Hypertension

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qualubia, 13111, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Inverted T trabeculectomy

Procedure

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.

Primary outcomes

Post op IOP

Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Inverted T Trabeculectomy for Primary Congenital Glaucoma, A Novel Technique

Acronym: Inverte T trab

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Feb 20, 2025
Registry last updated: Feb 20, 2025

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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