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

Alexandria University42 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Retinal Detachment Proliferative Vitreoretinopathy

Interventions

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

PlaceboDRUG

Eligibility

Sex: ALLMin age: 0 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Recurrent RD due to PVR

Clinical retinal detachment with any grade PVR

Time frame: 12 weeks post operative

Secondary Outcomes

Post operative PVR

Any grade or degree of PVR at 6 and 12 weeks in accordance with the updated classification of PVR of the Retina Society (1991).

Time frame: 12 weeks post operative

Best corrected visual acuity

BCVA measured by Landolt's broken ring or illiterate E charts within 6 and 12 weeks in cooperative children.

Time frame: 12 weeks post operative

Secondary procedures

Number and extent of surgical procedures necessary to achieve retinal re-attachment within 12 weeks.

Time frame: 12 weeks post operative

Data from ClinicalTrials.gov

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