Clinical Investigation of the WaveLight® EX500 Excimer Laser

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperopia; Hyperopic Astigmatism
• Intervention / Treatment: Device: WaveLight EX500 excimer laser system; Procedure: LASIK

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Durrie Vision
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Moyes Eye Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Physicians Protocol
  • North Dakota
    • W. Fargo, North Dakota, United States, 58078
      • Vance Thompson Vision ND
  • Texas
    • Houston, Texas, United States, 77004
      • Mann Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: WaveLight EX500 excimer laser system; Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: LASIK; Refractive errors
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia
• Other Study ID Numbers: RFD530-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No