Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT01556893
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2012-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creating LASIK Flaps With the LenSx Femtosecond Laser
Sponsor:
Alcon LenSx, Inc.
Organization:
Study Overview
Official Title:
Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.
Status:
COMPLETED
Status Verified Date:
2014-10
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:
This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.
Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.
Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.
Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.
Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: