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Completed

NCT Number: NCT07696104

Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification

This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery. Eighty-eight eligible participants were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure: bromfenac 0.09% twice daily for 2 weeks, bromfenac 0.09% twice daily for 4 weeks, diclofenac 0.1% four times daily for 4 weeks, or nepafenac 0.1% three times daily for 4 weeks. All patients received the same standard perioperative care and adjunctive dexamethasone treatment. The primary outcome was central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT) at 6 and 12 weeks after surgery. Secondary outcomes included best-corrected distance visual acuity, refraction, and intraocular pressure.

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Key information

Conditions

Pseudophakic Cystoid Macular Edema Cataract Eye Diseases Lens Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Clinical Hospital No. 2, Pomeranian Medical University in Szczecin

Szczecin, 70-111, Poland

About this study

Cystoid macular edema remains one of the most important causes of suboptimal visual outcomes after cataract surgery. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to reduce postoperative inflammation and the risk of macular thickening; however, the optimal NSAID regimen remains uncertain.

This prospective randomized clinical study was designed to compare the effectiveness of different postoperative NSAID regimens following uncomplicated phacoemulsification cataract surgery. Eligible patients scheduled for elective cataract surgery were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure. Participants underwent ophthalmic examinations before surgery and at 6 and 12 weeks after surgery.

The primary objective was to evaluate changes in central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT). Secondary assessments included best-corrected distance visual acuity, refraction, and intraocular pressure. All participants received standard perioperative care, and postoperative treatment was administered according to the assigned study regimen.

The study was approved by the Bioethics Committee of the Pomeranian Medical University in Szczecin, and all participants provided written informed consent before enrollment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults scheduled for elective uncomplicated phacoemulsification cataract surgery.
  • Ability and willingness to provide written informed consent.
  • No abnormalities detected on preoperative anterior segment examination.
  • No abnormalities detected on preoperative posterior segment examination.
  • Willingness and ability to attend follow-up visits at 6 and 12 weeks after cataract surgery.

Exclusion criteria

The exclusion criteria for the study were:

  • Systemic diseases that could affect the macula (e.g. diabetes).
  • Topical or systemic medications that could affect the macula, e.g. chloroquine.
  • Intraoperative complications.
  • Coexisting ocular diseases.
  • Previous ocular surgery.
  • Patients who. for various reasons. declared unwillingness to attend follow-up visits 6 and 12 weeks after cataract surgery.

Treatment and study plan

Bromfenac 0.09 % Ophthalmic Solution

Drug

Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.

Nepafenac 0.1% eyedrops

Drug

Nepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery.

diclofenac 0.1% ophthalmic susp.

Drug

Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery.

Primary outcomes

  1. Changes in Central Subfield Thickness After Cataract Surgery

    Time frame: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery

    Central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), to compare postoperative macular thickness among treatment groups receiving different topical nonsteroidal anti-inflammatory drug (NSAID) regimens following uncomplicated cataract surgery.

Secondary outcomes

  1. Correlation Between Central Subfield Thickness and Distance Best-Corrected Visual Acuity

    Time frame: 6 weeks and 12 weeks after cataract surgery compare to baseline

    Correlation between central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), and distance best-corrected visual acuity (DBCVA), reported as decimal visual acuity, measured using a Snellen chart, at 6 and 12 weeks after uncomplicated cataract surgery.

  2. Central Subfield Thickness by Postoperative Distance Best-Corrected Visual Acuity Group

    Time frame: 6 weeks and 12 weeks after cataract surgery

    Central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), compared between eyes with postoperative distance best-corrected visual acuity (DBCVA) <0.9 and eyes with postoperative DBCVA of 0.9-1.0, measured using a Snellen chart and reported as decimal visual acuity, at 6 and 12 weeks after uncomplicated cataract surgery.

  3. Change in Central Subfield Thickness From Baseline

    Time frame: Baseline, 6 weeks, and 12 weeks after cataract surgery

    Change in central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), from baseline (preoperative assessment) to 6 and 12 weeks after uncomplicated cataract surgery in all study participants, regardless of the assigned topical nonsteroidal anti-inflammatory drug (NSAID) regimen.

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2026
Registry last updated
Jul 10, 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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