Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 10 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00366808
The ClinicalTrials.gov registry entry for NCT00366808 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LASIK surgery is the first listed.
NCT00366808 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.