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

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06166914
• Other study ID #: 9163209
• Status: Completed
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: May 21, 2023

Study information

• Verified date: December 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 21, 2023
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Proliferative Vitreoretinopathy
• Retinal Detachment

Intervention

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).
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent RD due to PVR	Clinical retinal detachment with any grade PVR	12 weeks post operative
Secondary	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
Secondary	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	Secondary procedures	Number and extent of surgical procedures necessary to achieve retinal re-attachment within 12 weeks.	12 weeks post operative