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.

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.

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.