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

NCT06166914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-12-19

No results posted yet for this study

Summary

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

Conditions

  • Retinal Detachment
  • Proliferative Vitreoretinopathy

Interventions

DRUG

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

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).

DRUG

Placebo

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.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2022-10-21
Completion
2023-05-21

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06166914 on ClinicalTrials.gov