Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366808
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2006-08-17
Brief Title:
Mechanical vs Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Mechanical vs Alcohol Separation of the Corneal Epithelium During Surface Ablation Refractive Procedures
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 D1 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None