NCT01443585UnknownNot Applicable
Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients
Ziv Hospital0 sites100 target enrollmentStarted: September 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Horizontal Intermediate Visual Field
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- 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
- •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
Outcomes
Primary Outcomes
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 Outcomes
- Subjective Evaluation of Visual Quality(2-3 weeks)
- Overall Subjective Feedback(2-3 weeks)
Investigators
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