Clinical Investigation of the WaveLight® EX500 Excimer Laser

NCT04805593 | Completed Results FDA Device

• 1 other identifier: RFD530-P001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

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.

Conditions

Hyperopia; Hyperopic Astigmatism

Keywords

LASIK; Refractive errors

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

WaveLight EX500 excimer laser system

EXPERIMENTAL

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

Device: WaveLight EX500 excimer laser system; Procedure: LASIK

Interventions

WaveLight EX500 excimer laser system DEVICE

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.

WaveLight EX500 excimer laser system

LASIK PROCEDURE

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.

WaveLight EX500 excimer laser system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intended to treat bilaterally;
• Hyperopia with or without astigmatism as specified in the protocol;
• Stable vision as specified in the protocol;

You may not qualify if:

• Glaucoma;
• Cataracts;
• Previous eye surgery;
• Intent to have monovision treatment;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

Durrie Vision

Overland Park, Kansas, 66210, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Physicians Protocol

Greensboro, North Carolina, 27401, United States

Location

Vance Thompson Vision ND

West Fargo, North Dakota, 58078, United States

Location

Mann Eye Institute

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Hyperopia; Astigmatism; Refractive Errors

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Results Point of Contact

• Title: Clinical Projects Director, Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

18884513937

Study Officials

• Sr. Clinical Trial Lead, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: April 28, 2021
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: August 21, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)