Phase 4
Completed N=79
Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery
Source: ClinicalTrials.gov NCT00494494 ↗Enrolled (actual)
79
Serious AEs
—
Results posted
Jul 2011
Primary outcomePrimary: Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) — 2.78; 5.6 microns — p=0.7029
Summary
Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative cystoid macular edema following uncomplicated cataract surgery
Participants: Patients having cataract surgery at UNC who meet eligibility criteria
Procedures (methods): Patients will have pre and post-operative vision measured and optical coherence tomography (OCT) testing, also cataract density and intraoperative phacoemulsification parameters including ultrasound power and ultrasound time will be measured. Patients will be randomized into two groups. Group 1 will be treated with standard post-operative cataract management. Group 2 will be treated with standard post-operative cataract management plus topical nepafenac for one month. Post-operative macular thickness will be studied by analyzing the visual acuity and OCT measurements at two months post surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) |
2.78; 5.6 | 0.7029 |
| PRIMARY Pre-operative Best Corrected Visual Acuity (BCVA) |
38.48; 40.49 | 0.1937 |
| PRIMARY Foveal Thickness |
-2.0; 4.7 | 0.5066 |
| PRIMARY Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups) |
0.05; 0.10 | 0.5099 |
| PRIMARY Post-operative Best Corrected Visual Acuity (BCVA) |
54.46; 55.49 | 0.5005 |
Eligibility Criteria
Inclusion Criteria
- over age 50
- having cataract surgery at UNC
Exclusion Criteria
- medically controlled diabetes
- history of intraocular surgery
- abnormal pre-op optical coherence tomography scan
- history of ocular inflammation
- have age related macular degeneration
Data sourced from ClinicalTrials.gov (NCT00494494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.