Rhegmatogenous Retinal Detachment With Grade C Proliferative VitreoretinopathyNCT07787377
Comparison of Visual Outcomes of Pars Plana Vitrectomy With and Without Injection Clexane for Rhegmatogenous Retinal Detachment Proliferative Vitreoretinopathy
A study testing Enoxaparin Sodium and Pars Plana Vitrectomy in people with Rhegmatogenous Retinal Detachment With Grade C Proliferative Vitreoretinopathy, run by Lahore General Hospital at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment With Grade C Proliferative Vitreoretinopathy
- What is being tested?
- Enoxaparin Sodium and Pars Plana Vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 30 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
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.
- Being tested
- Enoxaparin Sodium, Pars Plana Vitrectomy
- Keywords
- Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy, Grade C Proliferative Vitreoretinopathy, Pars Plana Vitrectomy, Enoxaparin Sodium
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin SodiumDrug
Enoxaparin sodium 40 mg/0.04 mL was added to the infusion bottle used during pars plana vitrectomy.
Pars Plana VitrectomyProcedure or surgery
Participants underwent pars plana vitrectomy for rhegmatogenous retinal detachment with grade C proliferative vitreoretinopathy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Pars Plana Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal Detachment With Grade C Proliferative VitreoretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Ahmad Fauzan, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787377
- Sponsor's protocol ID
- LahoreGeneralH18
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No