Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000122
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Fluorouracil Filtering Surgery Study FFSS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-09
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:
To determine whether postoperative subconjunctival injections of 5-fluorouracil 5-FU increase the success rate of filtering surgery in patients at high risk for failure after standard glaucoma filtering surgery
Detailed Description:
Filtering surgery adequately lowers intraocular pressure in most glaucoma patients However the prognosis is less favorable for aphakic patients with glaucoma or glaucoma in phakic eyes following unsuccessful filtering operations Failure of filtering surgery is usually attributed to the proliferation of fibroblasts at the filtering site The use of 5-FU an antimetabolite has been shown to inhibit the proliferation of fibroblasts in tissue culture and in preliminary studies it has increased the success of filtering surgery in a nonhuman primate model
The Fluorouracil Filtering Surgery Study FFSS was a randomized controlled clinical trial comparing the success rate of standard glaucoma filtering surgery to the success rate of standard surgery with adjunctive 5-FU treatment
Another element of this study was to evaluate the frequency and severity of possible adverse effects related to 5-FU injections Detailed preoperative and postoperative examinations of the cornea lens and retina were performed Systemic toxicity was assessed by preoperative and postoperative hematologic studies
After the investigators performed the filtering surgery and determined that the new outlet channel was working patients were randomized to receive either 5-FU injections or standard postsurgical care without 5-FU The patients treated with 5-FU received subconjunctival injections of 5 mg of 5-FU twice daily on postoperative days 1 through 7 and once daily on postoperative days 8 through 14 There were 213 patients recruited into the study 162 with previous cataract extraction and 51 with previous filtering surgery
All patients were examined at 1 month 3 months 6 months 1 year 18 months and 2 years postoperatively and at yearly intervals thereafter until 5 years postoperatively Possible concomitant risks of 5-FU treatment such as toxic effects to the cornea lens or retina were monitored
The Fluorouracil Filtering Surgery Study FFSS was a randomized controlled clinical trial comparing the success rate of standard glaucoma filtering surgery to the success rate of standard surgery with adjunctive 5-FU treatment
Another element of this study was to evaluate the frequency and severity of possible adverse effects related to 5-FU injections Detailed preoperative and postoperative examinations of the cornea lens and retina were performed Systemic toxicity was assessed by preoperative and postoperative hematologic studies
After the investigators performed the filtering surgery and determined that the new outlet channel was working patients were randomized to receive either 5-FU injections or standard postsurgical care without 5-FU The patients treated with 5-FU received subconjunctival injections of 5 mg of 5-FU twice daily on postoperative days 1 through 7 and once daily on postoperative days 8 through 14 There were 213 patients recruited into the study 162 with previous cataract extraction and 51 with previous filtering surgery
All patients were examined at 1 month 3 months 6 months 1 year 18 months and 2 years postoperatively and at yearly intervals thereafter until 5 years postoperatively Possible concomitant risks of 5-FU treatment such as toxic effects to the cornea lens or retina were monitored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None