Evaluation of the effect of subconjunctival 5-fluorouracil on the outcome of Ahmed valve in neovascular glaucoma: Randomized Clinical Trial

Comparison of success rate of AGV surgery with and without Adjunctive 5-fluorouracil treatment in patients with neovascular glaucoma

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.

This study will be performed on patients with neovascular glaucoma requiring shunt surgery who are referred to the glaucoma clinic of Rasoul Akram Hospital. Patients after randomization are divided into two groups. In the shunt surgery group alone, Ahmed shunt implanted in the superotemporal area at a distance of 10 mm from the limbus. In the shunt surgery with 5FU injection group, In addition to the shunt implantation in the previous method, 5FU is injected in the first, third and fifth weeks of follow-up. Patients are then examined regularly to evaluate the success and complications of treatment.

Inclusion criteria: Patients with neovascular glaucoma who require implant Ahmed shunt to control ocular pressure. Exclusion criteria: 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 with neovascular glaucoma are divided into two groups. In one group, patients underwent Ahmed shunt surgery and in the other group, patients underwent Ahmed shunt surgery with 5FU injection.

Success rate, incidence of hypertensive phase, complications, intraocular pressure before and after surgery, number of medication used before and after surgery.

For randomization, we will use the random block method so that the number of samples in the two groups is the same. The blocks are considered as 4, with a and b representing the two study groups. All possible permutations for a block of 4 are as follows: aabb, abba, abab, bbaa, baab, baba. From these 6 permutations, one block will be selected at a simple random time. The reason for this is to reduce the likelihood that final allocations will be predictable. After selecting the block, the person will be assigned to group a or b in the same way.