Perioperative Topical Nepafenac After Epiretinal Membrane Surgery

NCT07736690 | Completed Phase 4

• 1 other identifier: E2-26-14982
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective comparative study evaluates whether perioperative topical nepafenac improves early anatomical and functional recovery after pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. The study compares postoperative visual acuity, central macular thickness, and other clinical outcomes between patients treated with perioperative nepafenac and those receiving standard postoperative care.

Conditions

Epiretinal Membrane; Macular Pucker

Keywords

Epiretinal Membrane; Pars Plana Vitrectomy; Nepafenac; Internal Limiting Membrane Peeling; Optical Coherence Tomography; Anti-inflammatory Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Best-Corrected Visual Acuity (BCVA)

  To compare the change in best-corrected visual acuity (logMAR) between the perioperative nepafenac group and the control group following epiretinal membrane surgery.

  6 months after surgery

Secondary Outcomes (3)

• Change in Central Macular Thickness (CMT)

  6 months after surgery

• Integrity of the Ellipsoid Zone

  6 months after surgery

• Postoperative Complications

  6 months after surgery

Study Arms (2)

Arm 1: Nepafenac Group

EXPERIMENTAL

Participants received perioperative topical nepafenac in addition to pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling.

Drug: Nepafenac 0.1% Ophthalmic Suspension; Procedure: Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling

Arm 2: Control Group

ACTIVE COMPARATOR

Participants underwent pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling without perioperative topical nepafenac.

Procedure: Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling

Interventions

Nepafenac 0.1% Ophthalmic Suspension DRUG

Topical nepafenac 0.1% administered three times daily beginning one week before surgery and continued for four weeks after surgery, in addition to standard postoperative treatment.

Arm 1: Nepafenac Group

Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling PROCEDURE

Standard pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling performed for epiretinal membrane.

Arm 1: Nepafenac Group; Arm 2: Control Group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older.
• Diagnosis of idiopathic epiretinal membrane requiring pars plana vitrectomy.
• Best-corrected visual acuity impairment and/or metamorphopsia attributed to epiretinal membrane.
• Ability to provide written informed consent.
• Willingness to complete the scheduled follow-up examinations for 6 months.

You may not qualify if:

• \- Previous vitreoretinal surgery in the study eye.
• Other retinal diseases that could affect visual or anatomical outcomes (e.g., diabetic retinopathy, retinal vein occlusion, age-related macular degeneration).
• Significant ocular trauma.
• Active ocular inflammation or infection.
• Advanced glaucoma or optic neuropathy affecting visual function.
• Media opacity preventing adequate retinal imaging.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

nepafenac

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were assigned to one of two parallel groups. One group received perioperative topical nepafenac in addition to standard surgical treatment, while the control group received standard surgical treatment without perioperative nepafenac. Outcomes were compared between the two groups during postoperative follow-up.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)