Clinical Evaluation of a Progressive Addition Lens (PAL)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01443585
First received: September 14, 2011
Last updated: March 14, 2013
Last verified: September 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Visual Acuity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Horizontal Near Visual Field [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Field of comfortable reading on a computer screen [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Horizontal Far Visual Field [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective Evaluation of Visual Quality [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
  • Overall Subjective Feedback [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443585

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

No publications provided

Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT01443585     History of Changes
Other Study ID Numbers: PALsCTIL
Study First Received: September 14, 2011
Last Updated: March 14, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
Progressive Addition Lens
Multifocal
Presbyopia

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014