Comparison of Visual Outcomes of Pars Plana Vitrectomy With and Without Injection Clexane for Rhegmatogenous Retinal Detachment Proliferative Vitreoretinopathy

NCT07787377 | Active Not Recruiting

• 1 other identifier: LahoreGeneralH18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhegmatogenous Retinal Detachment With Grade C Proliferative Vitreoretinopathy

Keywords

Rhegmatogenous Retinal Detachment; Proliferative Vitreoretinopathy; Grade C Proliferative Vitreoretinopathy; Pars Plana Vitrectomy; Enoxaparin Sodium

Outcome Measures

Primary Outcomes (1)

• Postoperative Visual Acuity

  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.

  3 months after surgery

Study Arms (2)

Group Enoxaparin Sodium

EXPERIMENTAL

Participants underwent pars plana vitrectomy for rhegmatogenous retinal detachment with grade C proliferative vitreoretinopathy. Enoxaparin sodium 40 mg/0.04 mL was admixed in the intraoperative infusion bottle during surgery.

Drug: Enoxaparin Sodium; Procedure: Pars Plana Vitrectomy

Group Without Enoxaparin Sodium

ACTIVE COMPARATOR

Participants underwent pars plana vitrectomy for rhegmatogenous retinal detachment with grade C proliferative vitreoretinopathy without enoxaparin sodium/Clexane in the intraoperative infusion bottle.

Procedure: Pars Plana Vitrectomy

Interventions

Enoxaparin Sodium DRUG

Enoxaparin sodium 40 mg/0.04 mL was added to the infusion bottle used during pars plana vitrectomy.

Group Enoxaparin Sodium

Pars Plana Vitrectomy PROCEDURE

Participants underwent pars plana vitrectomy for rhegmatogenous retinal detachment with grade C proliferative vitreoretinopathy.

Group Enoxaparin Sodium; Group Without Enoxaparin Sodium

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Interventions

enoxaparin sodium

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Ahmad Fauzan

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

PA (1)