LASIK iDesign vs SMILE

NCT07126756 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-08-17

No results posted yet for this study

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

Interventions

DEVICE

STAR S4 IR Excimer Laser System

LASIK with iDesign

DEVICE

VisuMax 400 Surgical Laser

small incision lenticule extraction technique

Sponsors & Collaborators

  • United States Army Aeromedical Research Laboratory

    collaborator FED
  • 59th Medical Wing

    lead FED

Principal Investigators

  • Charisma B Evangelista, MD · Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2025-12-31
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07126756 on ClinicalTrials.gov