Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal

Clinical Evaluation of the Biofinity Multifocal Lens Compared With the Air Optix Aqua Multifocal Lens and With PureVision Multifocal Lens (INNOVATION PRESBYOPIA Study)

This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.

This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.

Each subject will have 5 visits with the investigator:

• (V1) An inclusion visit during which the first pair of lenses are fitted;
• (V2) An optimization visit after 7 to 9 days of wearing the first lens;
• (V3) An evaluation visit after an additional 10 to 15 days of wearing the first lens (17 to 24 days) and at which time the second pair of lenses are fitted;
• (V4, V5) Visits are conducted as in V 2 and V3 with the second pair of lenses.

Inclusion Criteria:

• Male and female patients, aged 18 years or older
• Patients with proven presbyopia
• Patients who do not wear contact lenses or who wore spherical lenses before being included in the study
• Myopic patients whose spherical equivalent is less than or equal to 9.00 D (or a "lens" power less than or equal to -8,00 D) or hypermetropic patients whose spherical equivalent is less than or equal to +5.50 D (or a "lens" power less than or equal to +6,00 D) or emmetropic patients for distance vision (plan)
• Patient able to fill in a diary without help
• Patients who gave their informed consent to take part in the study

Exclusion Criteria:

• Patients with a contra-indication for wearing contact lenses
• Patients suffering from any ocular pathology that might interfere with the evaluation of the lenses
• Patients wearing multifocal lenses or spherical lenses for monovision before being included in the study
• Astigmatic patients whose cylinder is more than 0.75 D