Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-26 @ 9:25 PM
Study NCT ID:
NCT06745856
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2023-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative 5-fluorouracil Augmentation of Trabeculectomy
Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Organization:
Study Overview
Official Title:
A Trial of Intraoperative 5-fluorouracil in Primary Glaucoma Filtration Surgery: Effects on Long Term Intraocular Pressure Control and Disease Progression
Status:
COMPLETED
Status Verified Date:
2024-12
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:
MoreFlow
Brief Summary:
5-fluorouracil (5FU) is an antimetabolite that has been demonstrated to have beneficial effects when injected into the subconjunctival space after glaucoma surgery (trabeculectomy). The hypothesis of this study is that a similar beneficial effect can be achieved with a single intraoperative application of 5FU. This hypothesis is tested with a randomized control study.
Detailed Description:
Glaucoma is the commonest cause of irreversible blindness worldwide. Treatment is initially with topical medication, but when the intraocular pressure is still poorly controlled, surgical treatment is required. The surgical treatment of choice remains the trabeculectomy and this is often augmented with antimetabolite.
The choice of antimetabolite varies between surgeons, as does the indications for use. Postoperative delivery of the drug can be uncomfortable for the patient and time consuming. This study examines the potential benefits and side effect profile of intraoperative 5FU compared to unaugmented trabeculectomy.
The patients are recruited from Moorfields Eye Hospital and followed up by the staff from the glaucoma department.
The choice of antimetabolite varies between surgeons, as does the indications for use. Postoperative delivery of the drug can be uncomfortable for the patient and time consuming. This study examines the potential benefits and side effect profile of intraoperative 5FU compared to unaugmented trabeculectomy.
The patients are recruited from Moorfields Eye Hospital and followed up by the staff from the glaucoma department.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: