Rhegmatogenous Retinal Detachment With Grade C Proliferative Vitreoretinopathy
Conditions
Keywords
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy, Grade C Proliferative Vitreoretinopathy, Pars Plana Vitrectomy, Enoxaparin Sodium
Brief summary
This interventional prospective study was conducted in the Department of Ophthalmology at Lahore General Hospital, Lahore. The study included 60 male and female patients aged 18-65 years who had rhegmatogenous retinal detachment associated with grade C proliferative vitreoretinopathy (PVR) and who met the predefined eligibility criteria. All participants underwent pars plana vitrectomy (PPV) for retinal detachment repair. Participants were treated either with enoxaparin sodium (Clexane) added during surgery or with the same surgical procedure without enoxaparin sodium. The study was designed to determine whether the use of enoxaparin sodium during PPV could improve postoperative visual outcome compared with PPV performed without enoxaparin. Enoxaparin was evaluated because of its anticoagulant and anti-inflammatory properties and its possible role in reducing postoperative inflammatory changes associated with proliferative vitreoretinopathy. Visual acuity was assessed before surgery and after surgery using a Snellen visual acuity chart. Relevant demographic and clinical information, ophthalmic examination findings, diagnosis, surgical procedure, preoperative visual acuity, postoperative visual acuity, and treatment outcome were recorded. The main comparison between the two study groups was the postoperative visual acuity following pars plana vitrectomy with versus without intraoperative enoxaparin sodium.
Interventions
DRUGEnoxaparin Sodium
Enoxaparin sodium 40 mg/0.04 mL was added to the infusion bottle used during pars plana vitrectomy.
PROCEDUREPars Plana Vitrectomy
Participants underwent pars plana vitrectomy for rhegmatogenous retinal detachment with grade C proliferative vitreoretinopathy.
Sponsors
Lahore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged 18-65 years. * Rhegmatogenous retinal detachment with grade C proliferative vitreoretinopathy in the study eye. * Patients with a clear crystalline lens or pseudophakia in the study eye.
Exclusion criteria
* Giant retinal tear in the study eye measuring more than 3 clock hours. * Patients scheduled for combined pars plana vitrectomy and cataract surgery for retinal detachment repair in the study eye. * Chronic inflammatory condition involving the study eye. * History of perforating or non-perforating ocular trauma in the study eye. * Cataract surgery within the preceding 3 months in the study eye. * Previous retinal procedures in the study eye within the preceding 6 months, including laserpexy, cryopexy, intravitreal gas injection, anti-vascular endothelial growth factor injection, or corticosteroid injection. * Single-eyed patients, defined in the synopsis as having best-corrected visual acuity in the fellow eye of \>1.0 logMAR, \<0.1 decimal, \<1/10, or \<6/60 Snellen fraction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Visual Acuity | 3 months after surgery | Postoperative distance visual acuity was assessed using a Snellen visual acuity chart and compared between participants undergoing pars plana vitrectomy with intraoperative enoxaparin sodium and those undergoing pars plana vitrectomy without enoxaparin sodium. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORAhmad Fauzan
Lahore General Hospital, Lahore
Outcome results
None listed