Clinical Evaluation of a Progressive Addition Lens (PAL)

Ziv Hospital

Status: Unknown

Conditions: Presbyopia

Treatments: Device: Progressive Addition Lens (Shamir PrimeIITM) Spectacles

Study type: Interventional

Funder types: Other

Identifiers

NCT01443585

PALsCTIL

Details and patient eligibility

About

The purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients.

This evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An ability to comprehend and give an informed consent for participation in the trial
• Presbyopia

Exclusion criteria

• Concurrent participation in another clinical trial
• Age<18
• For female subjects: pregnancy \ planning a pregnancy \ lactating at the time of enrollment
• Imbalanced diabetes \ high blood pressure \ thyroid disease
• Infectious disease
• Inability (cognitively) to comprehend the instructions given during the trial and to comply with them

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)