LASIK iDesign vs SMILE (TG-LASIK vs SM)

59th Medical Wing

Status

Active, not recruiting

Conditions

Myopia

Astigmatism

Treatments

Device: STAR S4 IR Excimer Laser System

Device: VisuMax 400 Surgical Laser

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT07126756

C.2024.066

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 estimated patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Nearsightedness (myopia) between -2.00 diopters and -8.00 diopters
Have similar levels of nearsightedness in each eye (2D or less difference between eyes)
Less than or equal to 3.00 diopters of astigmatism
Total spherical equivalent (SE) of no more than -8.0 D
Tricare Prime/Select Beneficiary (military health insurance)
Residing within 60 miles radius from Lackland AFB

Exclusion criteria

Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and volunteers whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (um) of corneal stroma from the corneal endothelium.
Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases
Pregnant or nursing females (pregnancy test will be performed on females subjects of childbearing potential)
Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy
Any ocular disease such as advanced/uncontrolled glaucoma, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection.
0.25 or 0.50 of manifest astigmatism in the eye randomized to SMILE
Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.
Potential candidate who cannot provide Informed Consent will not be allowed to participate.