Clinical Investigation of the WaveLight® EX500 Excimer Laser

Not Applicable

Completed

• Conditions: Hyperopic Astigmatism; Hyperopia
• Interventions: Device: WaveLight EX500 excimer laser system; Procedure: LASIK

• Registration Number: NCT04805593
• Lead Sponsor: Alcon Research

Brief 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.

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-04-28
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-02
• Results First Submitted: 2024-04-26
• Results First Submitted QC: 2024-04-26
• Results First Posted: 2024-05-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WaveLight EX500 excimer laser system	LASIK	Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
WaveLight EX500 excimer laser system	WaveLight EX500 excimer laser system	Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability	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)	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.
Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability	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)	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.
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)	Up to Month 12 postoperative	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.

Trial Locations

Locations (5)

Durrie Vision; 🇺🇸 Overland Park, Kansas, United States

Vance Thompson Vision ND; 🇺🇸 W. Fargo, North Dakota, United States

Physicians Protocol; 🇺🇸 Greensboro, North Carolina, United States

Mann Eye Institute; 🇺🇸 Houston, Texas, United States

Moyes Eye Center; 🇺🇸 Kansas City, Missouri, United States