NCT05844397

SMILE vs. LASIK Using Contoura With Phorcides

Comparison of Clinical Outcomes of SMILE vs. LASIK Using Contoura With Phorcides

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: 59th Medical Wing · Federal
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.

Detailed description

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 Contoura with Phorcides on the contralateral eye to correct myopia.The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using Contoura with Phorcides and SMILE surgery. 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 week 2, month 1, month 3, and month 6.

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	WaveLight EX500 Excimer Laser System	LASIK Refractive Surgery Using Contura with Phorcides
DEVICE	VisuMax Surgical Laser	SMILE Refractive Surgery

Timeline

• Start date: 2023-05-09
• Primary completion: 2024-05-14
• Completion: 2024-05-14
• First posted: 2023-05-06
• Last updated: 2025-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study