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NCT00494494 · ClinicalTrials.gov registry record · Phase 4
Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT00494494: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT00494494 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 82 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00494494, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study 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.
Primary Outcome
The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)
Interventions
- DRUG Standard Care
- DRUG nepafenac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
What the finished NCT00494494 record still lists
NCT00494494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT00494494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00494494 about?
NCT00494494 is a clinical study titled "Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery". 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-opera...
What is the current status of trial NCT00494494?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2007-06. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00494494?
The interventions under investigation include: Standard Care (DRUG), nepafenac (DRUG).
Who is sponsoring clinical trial NCT00494494?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00494494's enrollment target sits among peer trials
82 939th of 2000 higher than 1,061 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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