Clinical Investigation of the WaveLight® EX500 Excimer Laser

Not Applicable

Completed

• Conditions: Hyperopia; Hyperopic Astigmatism

• Registration Number: NCT04805593
• Lead Sponsor: Alcon Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-3-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Key Inclusion Criteria:<br><br> - Intended to treat bilaterally;<br><br> - Hyperopia with or without astigmatism as specified in the protocol;<br><br> - Stable vision as specified in the protocol;<br><br> - Other protocol-defined inclusion criteria may apply.<br><br>Key Exclusion Criteria:<br><br> - Glaucoma;<br><br> - Cataracts;<br><br> - Previous eye surgery;<br><br> - Intent to have monovision treatment;<br><br> - Other protocol-defined exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability;Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability;Percentage of Eyes Experiencing Ocular Adverse Events (AEs)