Any Unique Identifier Assigned to the Protocol by the Sponsor

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neovascular Glaucoma
• Intervention / Treatment: Procedure: AGV implantation

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1445613131
    • Iran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AGV with intraoperation MMC; 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.	Procedure: AGV implantation; 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
Active Comparator: 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.	Procedure: AGV implantation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate (SR)	1. Reduction of at least 20% IOP after surgery 2. 21> IOP> 6 with or without medication	Sixth month
Hypertensive Phase (HP)	IOP>21 after surgery	Third month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of mediaction	Number of antiglauocoma medication after surgery	Sixth month

Collaborators and Investigators

• Sponsor: Iran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: MMC; 5FU; Neovascular Glaucoma (NVG); Ahmed Glaucoma Valve (AGV)
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Neovascular
• Other Study ID Numbers: 1400-2-86-21845

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes