Skip to content

Perioperative Topical Nepafenac After Epiretinal Membrane Surgery

Perioperative Topical Nepafenac Enhances Early Anatomical and Functional Recovery After Epiretinal Membrane Surgery: A Prospective Comparative Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07736690
Acronym
NEPERM
Enrollment
60
Registered
2026-07-30
Start date
2024-01-01
Completion date
2026-01-01
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane, Macular Pucker

Keywords

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

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.

Detailed description

Epiretinal membrane (ERM) surgery generally results in favorable anatomical outcomes; however, postoperative retinal inflammation may delay visual and structural recovery. Nepafenac is a topical nonsteroidal anti-inflammatory drug with excellent intraocular penetration and may reduce postoperative inflammation. This prospective comparative study investigates the effect of perioperative topical nepafenac on early postoperative recovery following pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. Participants were assigned to receive either perioperative topical nepafenac or standard postoperative treatment. The primary objective is to compare anatomical recovery, measured by optical coherence tomography, and functional recovery, assessed by best-corrected visual acuity. Secondary outcomes include changes in central macular thickness and postoperative complications. The findings may help determine whether perioperative topical nepafenac provides additional benefit in improving early postoperative outcomes after epiretinal membrane surgery.

Interventions

DRUGNepafenac 0.1% Ophthalmic Suspension

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.

PROCEDUREPars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling

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

Sponsors

Ankara Yildirim Beyazıt University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- * 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.

Exclusion criteria

* \- 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Best-Corrected Visual Acuity (BCVA)6 months after surgeryTo compare the change in best-corrected visual acuity (logMAR) between the perioperative nepafenac group and the control group following epiretinal membrane surgery.

Secondary

MeasureTime frameDescription
Change in Central Macular Thickness (CMT)6 months after surgeryTo compare postoperative central macular thickness measured by spectral-domain optical coherence tomography between the two groups.
Integrity of the Ellipsoid Zone6 months after surgeryTo evaluate postoperative restoration of the ellipsoid zone using optical coherence tomography.
Postoperative Complications6 months after surgeryTo compare the incidence of postoperative complications between the two treatment groups.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026