Clinical Evaluation of a Progressive Addition Lens (PAL)
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|ClinicalTrials.gov Identifier: NCT01443585|
Recruitment Status : Unknown
Verified September 2011 by Ziv Hospital.
Recruitment status was: Enrolling by invitation
First Posted : September 29, 2011
Last Update Posted : March 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Device: Progressive Addition Lens (Shamir PrimeIITM) Spectacles||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||November 2013|
- Device: Progressive Addition Lens (Shamir PrimeIITM) Spectacles
A pair of progressive addition lenses manufactured according to the subject's personal prescription.
- Horizontal Intermediate Visual Field [ Time Frame: Baseline ]
- Visual Acuity [ Time Frame: Baseline ]
- Horizontal Near Visual Field [ Time Frame: Baseline ]
- Field of comfortable reading on a computer screen [ Time Frame: Baseline ]
- Horizontal Far Visual Field [ Time Frame: Baseline ]
- Subjective Evaluation of Visual Quality [ Time Frame: 2-3 weeks ]
- Overall Subjective Feedback [ Time Frame: 2-3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443585
|Principal Investigator:||Yosef Pikel, M.D||Ziv Medical Center, Zefat, Israel|