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Clinical Evaluation of a Progressive Addition Lens (PAL)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Ziv Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01443585
First Posted: September 29, 2011
Last Update Posted: March 15, 2013
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.
Information provided by (Responsible Party):
Ziv Hospital
  Purpose

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 Intervention
Presbyopia Device: Progressive Addition Lens (Shamir PrimeIITM) Spectacles

Study Type: Interventional
Study Design: 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

Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Progressive Addition Lens (Shamir PrimeIITM) Spectacles
    A pair of progressive addition lenses manufactured according to the subject's personal prescription.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01443585


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

Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT01443585     History of Changes
Other Study ID Numbers: PALsCTIL
First Submitted: September 14, 2011
First Posted: September 29, 2011
Last Update Posted: March 15, 2013
Last Verified: September 2011

Keywords provided by Ziv Hospital:
Progressive Addition Lens
Multifocal
Presbyopia

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases