Proliferative Vitreoretinopathy, Retinal Detachment
Conditions
Keywords
pediatric retinal detachment, proliferative vitreoretinopathy, 5-Fluorouracil, Low molecular weight heparin
Brief summary
EVALUATION OF 5-FLOUROURACIL AND LOW MOLECULAR WEIGHT HEPARIN INTRAOPERATIVE INFUSION IN PREVENTING PROLIFERATIVE VITREORETINOPATHY IN HIGH RISK PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT
Detailed 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.
Interventions
DRUGIntraoperative 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).
DRUGPlacebo
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
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective randomized clinical trial of patients enrolled sequentially into group A (treatment) and group B (control)
Eligibility
Sex/Gender
ALL
Age
0 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent RD due to PVR | 12 weeks post operative | Clinical retinal detachment with any grade PVR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative PVR | 12 weeks post operative | Any grade or degree of PVR at 6 and 12 weeks in accordance with the updated classification of PVR of the Retina Society (1991). |
| Best corrected visual acuity | 12 weeks post operative | BCVA measured by Landolt's broken ring or illiterate E charts within 6 and 12 weeks in cooperative children. |
| Secondary procedures | 12 weeks post operative | Number and extent of surgical procedures necessary to achieve retinal re-attachment within 12 weeks. |
Countries
Egypt
Outcome results
None listed