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Clinical Evaluation of a Progressive Addition Lens (PAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Ziv Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients
Study Start Date : September 2012
Estimated Primary Completion Date : November 2013

Intervention Details:
  • Device: Progressive Addition Lens (Shamir PrimeIITM) Spectacles
    A pair of progressive addition lenses manufactured according to the subject's personal prescription.

Primary Outcome Measures :
  1. Horizontal Intermediate Visual Field [ Time Frame: Baseline ]
  2. Visual Acuity [ Time Frame: Baseline ]
  3. Horizontal Near Visual Field [ Time Frame: Baseline ]
  4. Field of comfortable reading on a computer screen [ Time Frame: Baseline ]
  5. Horizontal Far Visual Field [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Subjective Evaluation of Visual Quality [ Time Frame: 2-3 weeks ]
  2. Overall Subjective Feedback [ Time Frame: 2-3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01443585

Sponsors and Collaborators
Ziv Hospital
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Principal Investigator: Yosef Pikel, M.D Ziv Medical Center, Zefat, Israel

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Responsible Party: Ziv Hospital Identifier: NCT01443585     History of Changes
Other Study ID Numbers: PALsCTIL
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: September 2011
Keywords provided by Ziv Hospital:
Progressive Addition Lens
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases