Clinical Investigation of the WaveLight® EX500 Excimer Laser

Alcon

Status: Completed

Conditions: Hyperopic Astigmatism; Hyperopia

Treatments: Device: WaveLight EX500 excimer laser system; Procedure: LASIK

Study type: Interventional

Funder types: Industry

Identifiers

NCT04805593

RFD530-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

WaveLight EX500 excimer laser system

Experimental group

Description:

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

Treatment:

Procedure: LASIK

Device: WaveLight EX500 excimer laser system