Proliferative Vitreoretinopathy This is a scarring process that occurs in patients who have developed a retinal detachment. It is the primary cause of failure in retinal detachment surgery and occurs in 5-10% cases.
Conditions
Sponsors
Moorfields Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary retinal detachment complicated by proliferative vitreoretinopathy with grade equal to or greater than C1. Classification of PVR as described in: An updated classification of retinal detachment with proliferative vitreoretinopathy. Machemer R, Aarberg TM, Freeman HM et al. Am J Ophthalmol 1991;112(2):158-165. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Clinically significant coexisting ocular pathology other than retinal detachment. 2) Glaucoma, ocular hypertension, steroid responsive glaucoma. 3) Enrolment in other studies. 4) Inability to attend regular follow up. 5) Contraindication to any of the IMP's
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of administering a combination of pre, per and post operative anti-inflammatory adjuncts in patients undergoing vitrectomy and silicone oil for established proliferative vitreoretinopathy (PVR). The main outcome measure is anatomical success following retinal detachment surgery and the subsequent development of PVR. Anatomical success is defined as the absence of retinal detachment.;Secondary Objective: 1) Visual outcomes of patients (using LogMAR visual acuities) following the initial surgery and then following removal of silicone oil. 2) Number of operations required to achieve anatomical success. ;Primary end point(s): This will be the anatomical result at 6 months following removal of silicone oil. | — |
Countries
United Kingdom
Outcome results
None listed