LASIK iDesign vs SMILE

NCT ID: NCT07126756

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2026-01-31

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.

Conditions

Myopia; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LASIK using iDesign

LASIK guided by iDesign

Group Type: ACTIVE_COMPARATOR

STAR S4 IR Excimer Laser System

Intervention Type: DEVICE

LASIK with iDesign

SMILE

SMILE Refractive Surgery

Group Type: EXPERIMENTAL

VisuMax 400 Surgical Laser

Intervention Type: DEVICE

small incision lenticule extraction technique

Interventions

STAR S4 IR Excimer Laser System

LASIK with iDesign

Intervention Type: DEVICE

VisuMax 400 Surgical Laser

small incision lenticule extraction technique

Intervention Type: DEVICE

Other Intervention Names

iDesign Refractive Studio

Eligibility Criteria

Inclusion Criteria

1. Nearsightedness (myopia) between -2.00 diopters and -8.00 diopters

2. Have similar levels of nearsightedness in each eye (2D or less difference between eyes)

3. Less than or equal to 3.00 diopters of astigmatism

4. Total spherical equivalent (SE) of no more than -8.0 D

5. Tricare Prime/Select Beneficiary (military health insurance)

6. Residing within 60 miles radius from Lackland AFB

Exclusion Criteria

1. 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.

2. Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases

3. Pregnant or nursing females (pregnancy test will be performed on females subjects of childbearing potential)

4. Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy

5. 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.

6. 0.25 or 0.50 of manifest astigmatism in the eye randomized to SMILE

7. Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.

8. Potential candidate who cannot provide Informed Consent will not be allowed to participate.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Army Aeromedical Research Laboratory

FED

Sponsor Role: collaborator

59th Medical Wing

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charisma B Evangelista, MD

Role: PRINCIPAL_INVESTIGATOR

Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center

Locations

Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, United States

Countries

United States

References

Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127.

Reference Type: BACKGROUND

PMID: 36539217 (View on PubMed)

Bharti S, Bains HS. Active cyclotorsion error correction during LASIK for myopia and myopic astigmatism with the NIDEK EC-5000 CX III laser. J Refract Surg. 2007 Nov;23(9 Suppl):S1041-5. doi: 10.3928/1081-597X-20071102-11.

Reference Type: BACKGROUND

PMID: 18047004 (View on PubMed)

Other Identifiers

C.2024.066

Identifier Type: -

Identifier Source: org_study_id