An interventional study of Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml) and Placebo in Retinal Detachment and Proliferative Vitreoretinopathy, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 0 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Alexandria University · Not applicable, Interventional, and Prevention
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.
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's enrollment of 42 is below the median of 50 across 132 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
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)
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
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).
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.
Recurrent RD due to PVR
Clinical retinal detachment with any grade PVR
Time frame: 12 weeks post operative
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
Plan to share: Undecided
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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