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NCT Number: NCT07787377

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enoxaparin sodium

Drug

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

pars plana vitrectomy

Procedure

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

Primary outcomes

  1. Postoperative Visual Acuity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lahore General Hospital

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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