Ignite Creation Date:
2024-05-06 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05316142
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2022-03-30
Brief Title:
Any Unique Identifier Assigned to the Protocol by the Sponsor
Sponsor:
Iran University of Medical Sciences
Organization:
Iran University of Medical Sciences
Study Overview
Official Title:
Evaluation of the Effect of Subconjunctival 5-fluorouracil on the Outcome of Ahmed Valve in Neovascular Glaucoma Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 80 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 02 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 FU 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 01 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
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 80 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 02 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 FU 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 01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None