NCT05316142

Effect of Subconjunctival 5-fluorouracil on the Outcome of Ahmed Valve in Neovascular Glaucoma

Evaluation of the Effect of Subconjunctival 5-fluorouracil on the Outcome of Ahmed Valve in Neovascular Glaucoma: Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Iran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Neovascular glaucoma is a common and severe type of secondary closed-angle glaucoma. Topical treatments have variable effects and unfortunately often require surgery to control IOP. Although Glaucoma Drainage Device (GDD) such as Ahmed Glaucoma Valve (AGV) are a surgical choice in these patients, their effectiveness decreases over time. One of the main causes of failure in AGV surgery is the formation of scar tissue and fibrosis around the shunt plate. So, the aim of this study was to evaluate the effect of using MMC Intraoperative and 5FU Postoperative with AGV surgery in neovascular glaucoma patients according to a specific protocol, on the incidence of Hypertensive Phase (HP) and surgical success rate.

Detailed description

All patients with neovascular glaucoma who need surgery for the first time are included in the study. Inclusion criteria include patients over 18 years of age with neovascular glaucoma whose IOP is not controlled by medical treatment. Exclusion criteria Study includes: No Light Perception patients, age less than 18 years, history of any type of eye surgery including previous glaucoma and retinal surgeries (except uncomplicated cataract surgery), history of cyclodestructive procedures, pregnant patients. Patients after obtaining a history, especially of drugs and underlying diseases, under complete ophthalmic examination including: visual acuity (VA) and BCVA with Snelln chart, examination with slit lamp and performing dynamic gonioscopy using, IOP measurement with Goldmann Applanation Tonometer and corneal thickness measurement (CCT). . Patients are then randomized using permuted block design computer and placed in two groups of AGV surgery with anti-fibrotic treatment and AGV surgery alone. In AGV surgery, the conjunctiva of the superotemporal area is first dissected. The plate shunt is then threaded 10 mm from the limbus to the sclera with non-absorbable proline thread. The tube insertion is then performed using a 23g needle, and after fixing the scleral patch, the conjugate is threaded with 8.0 vicryl thread and the shunt surgery is completed. In all patients during surgery and before fixing the shunt plate, MMC is used with a sponge at a dose of 0.2 mg / ml for 2 minutes and then washed with a large amount of BSS. All patients receive intraviteral bevacizumab at the end of the operation. In the postoperative anti-fibrotic group during F/U in the first, third and fifth weeks, 5FU subconjunctival injection is performed after local anesthesia with tetracaine behind the slit lamp for all patients with a pressure above 6 mm Hg. 5FU with a volume of 0.1 ml containing 5 mg of drug is injected in the area of the tendon adjacent to the shunt plate. After surgery, patients undergo regular examinations. Patients at least on the first day, first week, third week, fifth week, third month, sixth month, twelfth month in terms of visual acuity, refraction, IOP, various surgical complications, the number of drugs used to control IOP are evaluated.

Conditions

• Neovascular Glaucoma

Interventions

Type	Name	Description
PROCEDURE	AGV with intraoperation MMC and postoperative BSS	This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world
PROCEDURE	AGV with intraoperation MMC and post operation 5FU	This method will use Ahmad FP7 model valve shunt (New World Medical, LA). First, 5FU at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-04-07
• Last updated: 2025-05-06

Locations

1 site across 1 country: Iran