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Completed
NCT07696104
Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification
Conditions: Pseudophakic Cystoid Macular Edema
Sex: All
Ages: 30 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 88
Sponsor: Pomeranian Medical University Szczecin
Location: University Clinical Hospital No. 2, Pomeranian Medical University in Szczecin Szczecin
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07696104). StuddyBuddy aggregates publicly available trial information.