Clinical Investigation of the WaveLight® EX500 Excimer Laser

Hyperopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805593
• Other study ID #: RFD530-P001
• Status: Completed
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: May 2, 2023

Study information

• Verified date: April 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Hyperopic Astigmatism

Intervention

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.

Locations

Country	Name	City	State
United States	Physicians Protocol	Greensboro	North Carolina
United States	Mann Eye Institute	Houston	Texas
United States	Moyes Eye Center	Kansas City	Missouri
United States	Durrie Vision	Overland Park	Kansas
United States	Vance Thompson Vision ND	W. Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability	A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.	Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
Primary	Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability	A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis.	Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
Primary	Percentage of Eyes Experiencing Ocular Adverse Events (AEs)	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint.	Up to Month 12 postoperative