A Phase 4 interventional study of Bromfenac 0.09 % Ophthalmic Solution and Bromfenac 0.09 % Ophthalmic Solution in Pseudophakic Cystoid Macular Edema, sponsored by Pomeranian Medical University Szczecin. Completed at 1 site in Poland. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Pomeranian Medical University Szczecin · Phase 4, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
The exclusion criteria for the study were:
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 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 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 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
Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.
Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
Nepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery.
Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery.
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.
Time frame: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks, and 12 weeks after cataract surgery
Plan to share: Undecided — A decision regarding the future sharing of individual participant data has not yet been made
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Pomeranian Medical University Szczecin