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

Alexandria University

Status: Completed

Conditions: Proliferative Vitreoretinopathy; Retinal Detachment

Treatments: Drug: Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06166914

9163209

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

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

Treatment:

Drug: Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml)

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo