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

NCT07696104 | Completed Phase 4

• 1 other identifier: MD-CATARACT-NSAID-2024
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pseudophakic Cystoid Macular Edema

Keywords

cataract; NSAID; PCME

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  6 weeks and 12 weeks after cataract surgery compare to baseline

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

  6 weeks and 12 weeks after cataract surgery

• Change in Central Subfield Thickness From Baseline

  Baseline, 6 weeks, and 12 weeks after cataract surgery

Study Arms (4)

Arm 1 Bromfenac 0.09% for 2 Weeks

EXPERIMENTAL

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

Arm 2 Bromfenac 0.09% for 4 Weeks

EXPERIMENTAL

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

Arm 3 - Diclofenac 0.1% for 4 Weeks

EXPERIMENTAL

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.

Arm 4 - Nepafenac 0.1% for 4 Weeks

EXPERIMENTAL

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

Interventions

Bromfenac 0.09 % Ophthalmic Solution DRUG

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

Arm 1 Bromfenac 0.09% for 2 Weeks

Nepafenac 0.1% eyedrops DRUG

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

Arm 4 - Nepafenac 0.1% for 4 Weeks

diclofenac 0.1% ophthalmic susp. DRUG

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

Arm 3 - Diclofenac 0.1% for 4 Weeks

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

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

Szczecin, 70-111, Poland

Location

MeSH Terms

Conditions

Cataract

Interventions

bromfenac; Ophthalmic Solutions; nepafenac; Diclofenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

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

Model Details: Participants were randomly assigned to one of four parallel treatment groups using a simple dice-based randomization procedure. Each participant received only one study treatment regimen and was followed for 12 weeks after cataract surgery.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 10, 2026
• Study Start: October 14, 2020
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: July 10, 2026

Record last verified: 2026-06

Locations

PL (1)