Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 9:08 PM
Study NCT ID:
NCT07126756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LASIK iDesign vs SMILE
Sponsor:
59th Medical Wing
Organization:
Study Overview
Official Title:
Visual Outcomes Comparison of LASIK Using Wavefront Optimized and SMILE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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:
TG-LASIK vs SM
Brief Summary:
The study will compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, higher order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using iDesign and SMILE surgery.
Detailed Description:
Both SMILE and LASIK treatments are FDA-approved and are both performed routinely as standard of care surgery in the US Military. However, there is limited literature comparing quality of vision after LASIK using iDesign and SMILE refractive surgery. Our objective is to study the 6-month visual outcomes (high and 5% low contrast visual acuity, refractive error, higher order aberrations) and subject reported quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms using the PROWL and SPEED questionnaires following contralateral LASIK using iDesign and SMILE surgery. This is a prospective randomized contralateral study, including 57 subjects. Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo simultaneous SMILE surgery in one eye and LASIK using iDesign on the contralateral eye to correct myopia. Surgical treatment will be randomized so there is a 50% chance to receive SMILE on the right eye and LASIK on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. Visual outcomes and patient self-reported symptoms will be assessed at day 1, week 2, month 1, month 3, and month 6.
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?:
True
Is an FDA AA801 Violation?: