Ignite Creation Date:
2025-12-18 @ 9:52 AM
Ignite Modification Date:
2025-12-23 @ 10:40 PM
Study NCT ID:
NCT06166914
Status:
None
Last Update Posted:
2023-12-19 00:00:00
First Post:
2023-12-04 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of 5-fluorouracil and Low Molecular Weight Heparin Intraoperative Infusion in Preventing Proliferative Vitreoretinopathy in High Risk Pediatric Rhegmatogenous Retinal Detachment
Status:
None
Status Verified Date:
2023-12
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:
None
Brief Summary:
After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml), group B received infusion of normal saline. Primary outcome was occurrence of recurrent PRRD within 12 weeks, secondary outcomes were occurrence of PVR, best corrected visual acuity (BCVA), number and timing of secondary procedures within 12 weeks.
Detailed Description:
None
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?: