Inverted T Trabeculectomy Primary Congenital Glaucoma | NCT06837610 | Trialant

Inverted T Trabeculectomy Primary Congenital Glaucoma | NCT06837610 | Trialant

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary congenital glaucoma surgey	Other	Compare the Novel inverted T technique to the classic trabeculectomy in treatment of primary congenital glaucoma	Procedure: Inverted T trabeculectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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