LASIK iDesign vs SMILE

NCT07126756 | Active Not Recruiting FDA Device

• 1 other identifier: C.2024.066
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Percentage of Eyes With Uncorrected Visual Acuity of 20/16 or Better at 6-month Post-Op

  Post-operative uncorrected visual acuity of 20/16 or better measure using the ETDRS chart reported as percentage of subjects; unit = percentage eyes with Uncorrected Visual Acuity

  6-month Post-Op

Secondary Outcomes (6)

• Difference in High Contrast Visual Acuity at 6-month Post-Op

  6-month Post-Op

• Difference in residual Refractive Error at 6-month Post-Op

  6-month Post-Op

• Difference in Low Contrast Visual Acuity at 6-month Post-Op

  6-month Post-Op

• Difference in residual Higher Order Aberrations at 6-month Post-Op

  6-month Post-Op

• Difference in overall satisfaction questionnaire score at 6-month Post-Op

  6-month Post-Op

Study Arms (2)

LASIK using iDesign

ACTIVE COMPARATOR

LASIK guided by iDesign

Device: STAR S4 IR Excimer Laser System

SMILE

EXPERIMENTAL

SMILE Refractive Surgery

Device: VisuMax 400 Surgical Laser

Interventions

STAR S4 IR Excimer Laser System DEVICE

LASIK with iDesign

Also known as: iDesign Refractive Studio

LASIK using iDesign

VisuMax 400 Surgical Laser DEVICE

small incision lenticule extraction technique

SMILE

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• 59th Medical Wing: lead
• United States Army Aeromedical Research Laboratory: collaborator

Study Sites (1)

Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, 78009, United States

Location

Related Publications (2)

• 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.

  PMID: 36539217 BACKGROUND

• 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.

  PMID: 18047004 BACKGROUND

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Charisma B Evangelista, MD

  Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective randomized contralateral study

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: June 10, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)