Perioperative Topical Nepafenac After Epiretinal Membrane Surgery

NCT07736690 — Phase 4, Completed, 60 participants, Ankara Yildirim Beyazıt University

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

RegistryNCT07736690, acronym NEPERM
StatusCompleted
PhasePhase 4
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment60 (Actual)
SponsorAnkara Yildirim Beyazıt University (Other)
ConditionsEpiretinal Membrane, Macular Pucker
InterventionsNepafenac 0.1% Ophthalmic Suspension, Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling (Drug, procedure)
Datesstart 2024-01-01, primary completion 2026-01-01, completion 2026-01-01, first posted 2026-07-30, last updated 2026-07-30
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Epiretinal Membrane All trials for Macular Pucker All trials of Nepafenac 0.1% Ophthalmic Suspension All trials of Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Arm 1: Nepafenac GroupExperimentalDrug: Nepafenac 0.1% Ophthalmic Suspension; Procedure: Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane PeelingParticipants received perioperative topical nepafenac in addition to pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling.
Arm 2: Control GroupActive comparatorProcedure: Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane PeelingParticipants underwent pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling without perioperative topical nepafenac.
  • 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.
  • 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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • Change in Central Macular Thickness (CMT) [6 months after surgery]: To compare postoperative central macular thickness measured by spectral-domain optical coherence tomography between the two groups.
  • Integrity of the Ellipsoid Zone [6 months after surgery]: To evaluate postoperative restoration of the ellipsoid zone using optical coherence tomography.
  • Postoperative Complications [6 months after surgery]: To compare the incidence of postoperative complications between the two treatment groups.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Ankara Bilkent City HospitalAnkara, AnkaraTurkey (Türkiye)