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.

Any Unique Identifier Assigned to the Protocol by the Sponsor

Neovascular Glaucoma

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.

AGV implantation

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

1. Reduction of at least 20% IOP after surgery 2. 21> IOP> 6 with or without medication

Number of antiglauocoma medication after surgery

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.

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.

Any Unique Identifier Assigned to the Protocol by the Sponsor

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status