NCT05611294

Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

A Visual Outcome Comparison of Topography Guided LASIK Versus Small Incision Lenticule Extraction: A Prospective Contralateral Eye Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Hoopes Vision · Academic / Other
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.

Detailed description

This is a prospective, randomized, simultaneous, contralateral eye study including at least 42 patients undergoing refractive correction surgery. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. Randomization will ensure 50% of Right Eyes will receive Topography-Guided LASIK and 50% of Right Eyes will receive Small Incision Lenticule Extraction. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Topography Guided LASIK Surgery	LASIK surgery, using corneal topography data in treatment profile, to correct myopia or myopia with astigmatism refractive error.
DEVICE	Small Incision Lenticule Extraction Surgery	Corneal lenticule formation using a femtosecond laser, with subsequent lenticule extraction, to correct myopia or myopia with astigmatism refractive error.

Timeline

• Start date: 2022-09-27
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2022-11-10
• Last updated: 2024-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study