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NCT00366808 · ClinicalTrials.gov registry record · Phase 4
Mechanical vs. Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT00366808: Completed Phase 4 study, sponsored by Medical University of South Carolina.
NCT00366808 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00366808, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
A recent survey of trends among the members of the American Society of Cataract and Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading surgical procedure for photorefractive corrections ranging from -0 to 3 diopters (D).1 The same survey, however, showed a clear trend of participating refractive surgeons toward surface ablation. Photorefractive keratectomy (PRK) was the first refractive surgery procedure approved and performed using the excimer laser. Several techniques of epithelial debridement have been tried with PRK-type surgery including mechanical debridement, laser transepithelial ablation, a rotating brush, and alcohol debridement. The Amadeus II microkeratome (Advanced Medical Optics Inc, Irvine, CA, USA) used for the creation of a LASIK flap has an upgradeable platform that will allow the user to perform mechanical separation of the corneal epithelium before photorefractive treatments. With the use of this device, the corneal epithelium can be separated from the underlying stroma without previous preparation of the corneal surface with alcohol. The separated epithelial sheet can either be removed or replaced on the operated cornea after photoablation. This surgical procedure, which has been called Epi-LASIK, represents an advanced alternative surface ablation photorefractive procedure for the correction of ametropia. The purpose of this study is to evaluate the clinical visual outcomes, healing rates, and patient satisfaction when performing surface ablation procedures using mechanical vs. alcohol separation of the epithelium.
Interventions
- PROCEDURE LASIK surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
What the finished NCT00366808 record still lists
NCT00366808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which LASIK surgery is the first listed.
NCT00366808 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00366808 about?
NCT00366808 is a clinical study titled "Mechanical vs. Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures". A recent survey of trends among the members of the American Society of Cataract and Refractive Surgery determined that laser in situ keratomileusis (LASIK) is the leading surgical procedure for photorefractive corrections ranging from -0 to 3 diopters (D).1 The same survey, however, showed a clear t...
What is the current status of trial NCT00366808?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2006-02. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00366808?
The interventions under investigation include: LASIK surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00366808?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00366808's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 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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