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

NCT ID: NCT06166914

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-21

Study Completion Date

2023-05-21

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.

Conditions

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Retinal Detachment Proliferative Vitreoretinopathy

Keywords

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pediatric retinal detachment proliferative vitreoretinopathy 5-Fluorouracil Low molecular weight heparin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized clinical trial of patients enrolled sequentially into group A (treatment) and group B (control)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment group

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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).

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

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
Minimum Eligible Age

0 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Nasr M, Abdelhadi A, Bessa A, Ibrahim TM. Efficacy of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) in high-risk pediatric retinal detachment; randomized clinical trial. BMC Ophthalmol. 2024 Mar 4;24(1):97. doi: 10.1186/s12886-024-03362-4.

Reference Type DERIVED
PMID: 38433191 (View on PubMed)

Other Identifiers

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9163209

Identifier Type: -

Identifier Source: org_study_id