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.

Study Overview

• Status: Completed
• Conditions: Pseudophakic Cystoid Macular Edema
• Intervention / Treatment: Drug: Bromfenac 0.09 % Ophthalmic Solution; Drug: Bromfenac 0.09 % Ophthalmic Solution; Drug: diclofenac 0.1% ophthalmic susp.; Drug: Nepafenac 0.1% eyedrops

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Szczecin, Poland, 70-111
    • University Clinical Hospital No. 2, Pomeranian Medical University in Szczecin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults scheduled for elective uncomplicated phacoemulsification cataract surgery.
2. Ability and willingness to provide written informed consent.
3. No abnormalities detected on preoperative anterior segment examination.
4. No abnormalities detected on preoperative posterior segment examination.
5. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 Bromfenac 0.09% for 2 Weeks; Arm 1 - Bromfenac 0.09% for 2 Weeks Participants received bromfenac 0.09% ophthalmic solution twice daily for 2 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment.	Drug: Bromfenac 0.09 % Ophthalmic Solution; Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.; Drug: Bromfenac 0.09 % Ophthalmic Solution; Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
Experimental: Arm 2 Bromfenac 0.09% for 4 Weeks; Arm 2 - Bromfenac 0.09% for 4 Weeks Participants received bromfenac 0.09% ophthalmic solution twice daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment.	Drug: Bromfenac 0.09 % Ophthalmic Solution; Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.; Drug: Bromfenac 0.09 % Ophthalmic Solution; Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
Experimental: Arm 3 - Diclofenac 0.1% for 4 Weeks; Arm 3 - Diclofenac 0.1% for 4 Weeks Participants received diclofenac 0.1% ophthalmic solution four times daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment.	Drug: diclofenac 0.1% ophthalmic susp.; Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery.
Experimental: Arm 4 - Nepafenac 0.1% for 4 Weeks; Arm 4 - Nepafenac 0.1% for 4 Weeks Participants received nepafenac 0.1% ophthalmic solution three times daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment.	Drug: Nepafenac 0.1% eyedrops; Nepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Central Subfield Thickness After 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.	Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Central Subfield Thickness and Distance Best-Corrected Visual Acuity	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.	6 weeks and 12 weeks after cataract surgery compare to baseline
Central Subfield Thickness by Postoperative Distance Best-Corrected Visual Acuity Group	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.	6 weeks and 12 weeks after cataract surgery
Change in Central Subfield Thickness From Baseline	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.	Baseline, 6 weeks, and 12 weeks after cataract surgery

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cataract; NSAID; PCME
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Pharmaceutical Solutions; Organic Chemicals; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Carboxylic Acids; Solutions; Specialty Uses of Chemicals; Acids, Carbocyclic; Phenylacetates; Ophthalmic Solutions; Diclofenac; nepafenac; bromfenac
• Other Study ID Numbers: MD-CATARACT-NSAID-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision regarding the future sharing of individual participant data has not yet been made

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No