NCT04805593

Clinical Investigation of the WaveLight® EX500 Excimer Laser

Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.

Detailed description

Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Month 12). Total expected duration of subject participation is approximately 1 year.

Conditions

• Hyperopia
• Hyperopic Astigmatism

Interventions

Type	Name	Description
DEVICE	WaveLight EX500 excimer laser system	FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.
PROCEDURE	LASIK	Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system.

Timeline

• Start date: 2021-04-28
• Primary completion: 2023-05-02
• Completion: 2023-05-02
• First posted: 2021-03-18
• Last updated: 2024-08-21
• Results posted: 2024-05-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study