N/A
N=30
Clinical Investigation of the WaveLight® EX500 Excimer Laser
Hyperopia · Hyperopic Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT04805593 ↗Enrolled (actual)
30
Serious AEs
1.7%
Results posted
May 2024
Primary outcome: Primary: Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability — 98.3 percentage of eyes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WaveLight EX500 excimer laser system (Device); LASIK (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability |
98.3 | <0.0001 sig |
| PRIMARY Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability |
100.0 | <0.0001 sig |
| PRIMARY Percentage of Eyes Experiencing Ocular Adverse Events (AEs) |
11.7; 6.7; 3.3; 1.7 | — |
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.
Eligibility Criteria
Key Inclusion Criteria
- Intended to treat bilaterally;
- Hyperopia with or without astigmatism as specified in the protocol;
- Stable vision as specified in the protocol;
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Glaucoma;
- Cataracts;
- Previous eye surgery;
- Intent to have monovision treatment;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04805593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.