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

NCT ID: NCT05316142

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

AGV with intraoperation MMC and postoperative BSS

Patients with neovascular glaucoma undergoing shunt implant surgery with MMC during surgery. 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. First, MMC at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications.

Also in the first, third and fifth weeks, BSS injections are given as a subconjugate with a volume of 0.1 ml.

Group Type: ACTIVE_COMPARATOR

AGV with intraoperation MMC and postoperative BSS

Intervention Type: PROCEDURE

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

AGV with intraoperation MMC and postoperation 5FU

Patients with neovascular glaucoma undergoing shunt implant surgery with MMC during and 5FU after surgery .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. First, 5FU at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Also in the first, third and fifth weeks, 5FU injections are given as a subconjugate with a volume of 0.1 ml containing 5 mg of the drug.

Group Type: ACTIVE_COMPARATOR

AGV with intraoperation MMC and post operation 5FU

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with diagnosis of neovascular glaucoma

Exclusion Criteria

• Patients with no light perception
• Patients aged less than 18 years old
• History of previous GDD implantation
• History of cyclodestructive procedures
• Pregnant patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Iran University of Medical Sciences

Tehran, , Iran

Countries

Iran

Other Identifiers

1400-2-86-21845

Identifier Type: -

Identifier Source: org_study_id