Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment

Not Applicable

Completed

• Conditions: Proliferative Vitreoretinopathy; Retinal Detachment
• Interventions: Drug: Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml); Drug: Placebo

• Registration Number: NCT06166914
• Lead Sponsor: Alexandria University

Brief Summary

EVALUATION OF 5-FLOUROURACIL AND LOW MOLECULAR WEIGHT HEPARIN INTRAOPERATIVE INFUSION IN PREVENTING PROLIFERATIVE VITREORETINOPATHY IN HIGH RISK PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT

Detailed Description

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.

Study Timeline

• Study Start: 2021-10-21
• Primary Completion: 2022-10-21
• Study Completion: 2023-05-21
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Children under 14 years of age with RRD undergoing primary repair Preoperative PVR grade B or higher High risk RRD: uveitis; large, giant, or multiple tears; vitreous hemorrhage; preoperative choroidal detachments; aphakia; and large detachments involving greater than two quadrants of the eye

Exclusion Criteria

Children with RRD related to penetrating ocular trauma involving the posterior segment Previous RD repair surgery Uncontrolled glaucoma or other concomitant ocular morbidities Patients with bleeding diathesis, hepatic and renal failure Corneal opacity sufficient to impair surgical view No light perception vision Inability to complete follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml)	Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml) during pars plana vitrectomy and silicone oil injection with scleral buckle in children under 14 years of age with high-risk PRRD
Control group	Placebo	Group B received infusion of normal saline during pars plana vitrectomy and silicone oil injection with scleral buckle in children under 14 years of age with high-risk PRRD

Primary Outcome Measures

Name	Time	Method
Recurrent RD due to PVR	12 weeks post operative	Clinical retinal detachment with any grade PVR

Secondary Outcome Measures

Name	Time	Method
Secondary procedures	12 weeks post operative	Number and extent of surgical procedures necessary to achieve retinal re-attachment within 12 weeks.
Post operative PVR	12 weeks post operative	Any grade or degree of PVR at 6 and 12 weeks in accordance with the updated classification of PVR of the Retina Society (1991).
Best corrected visual acuity	12 weeks post operative	BCVA measured by Landolt's broken ring or illiterate E charts within 6 and 12 weeks in cooperative children.

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria University; 🇪🇬 Alexandria, Egypt