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

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

Detailed Description
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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.

Official Title
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Evaluation of 5-fluorouracil and Low Molecular Weight Heparin Intraoperative Infusion in Preventing Proliferative Vitreoretinopathy in High Risk Pediatric Rhegmatogenous Retinal Detachment

Conditions
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Retinal Detachment, Proliferative Vitreoretinopathy

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized clinical trial of patients enrolled sequentially into group A (treatment) and group B (control)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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 | Drug: Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml)<br>* 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).<br>|
| Placebo Comparator: Control group<br>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 | Drug: Placebo<br>* 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 B received infusion of normal saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent RD due to PVR | Clinical retinal detachment with any grade PVR | 12 weeks post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 12 weeks post operative | 
| Secondary procedures | Number and extent of surgical procedures necessary to achieve retinal re-attachment within 12 weeks. | 12 weeks post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric retinal detachment, proliferative vitreoretinopathy, 5-Fluorouracil, Low molecular weight heparin