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

NCT05316142 | Active Not Recruiting DMC

• 1 other identifier: 1400-2-86-21845
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Glaucoma

Keywords

Neovascular Glaucoma (NVG); Ahmed Glaucoma Valve (AGV); 5FU; MMC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of mediaction

  Sixth month

Study Arms (2)

AGV with intraoperation MMC and postoperative BSS

ACTIVE COMPARATOR

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.

Procedure: AGV with intraoperation MMC and postoperative BSS

AGV with intraoperation MMC and postoperation 5FU

ACTIVE COMPARATOR

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 with intraoperation MMC and post operation 5FU

Interventions

AGV with intraoperation MMC and postoperative BSS 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 postoperative BSS

AGV with intraoperation MMC and post operation 5FU 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.

AGV with intraoperation MMC and postoperation 5FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosis of neovascular glaucoma

You may not qualify if:

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

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (1)

Iran University of Medical Sciences

Tehran, 1445613131, Iran

Location

MeSH Terms

Conditions

Glaucoma, Neovascular

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial study with two parallel groups, randomized using computer permuted block randomization, 35 patients in each group are included and followed up for at least 6 months.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2024-09

Locations

IR (1)