Pseudophakic Cystoid Macular Edema
Conditions
Keywords
cataract, NSAID, PCME
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.
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.
Interventions
Bromfenac 0.09% ophthalmic solution administered twice daily for 2 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.
Sponsors
Pomeranian Medical University Szczecin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Central Subfield Thickness After Cataract Surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Central Subfield Thickness and Distance Best-Corrected Visual Acuity | 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. |
| Central Subfield Thickness by Postoperative Distance Best-Corrected Visual Acuity Group | 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. |
| Change in Central Subfield Thickness From Baseline | 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. |
Countries
Poland
Outcome results
None listed