Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05316142 |
| Other study ID # |
1400-2-86-21845 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2024 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
September 2023 |
| Source |
Iran University of Medical Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
