Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05611294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
Sponsor:
Hoopes Vision
Organization:
Study Overview
Official Title:
A Visual Outcome Comparison of Topography Guided LASIK Versus Small Incision Lenticule Extraction: A Prospective Contralateral Eye Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.
Detailed Description:
This is a prospective, randomized, simultaneous, contralateral eye study including at least 42 patients undergoing refractive correction surgery. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. Randomization will ensure 50% of Right Eyes will receive Topography-Guided LASIK and 50% of Right Eyes will receive Small Incision Lenticule Extraction. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: