- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01234207
Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle (CZV_PAL1)
April 17, 2017 updated by: Meng C. Lin, University of California, Berkeley
The purpose of this study was to compare objective clinical measures of visual performance and subjective measures of satisfaction and preference between standard progressive addition lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL spectacle.
Study Overview
Status
Completed
Conditions
Detailed Description
In a double-masked crossover trial, 95 experienced wearers wore customized free-form PAL spectacles (Test) and standard non-free-form PAL spectacles (Control) for one week each.
All subjects wore both Test and Control spectacles, and the pair to be worn first was randomly assigned.
At dispensing and after 1 week of wear, subjects were tested for distance and near visual acuity (VA) under both high and low contrast; in addition, 30 degree off-axis VA was measured using a novel apparatus, as was the horizontal extent of undistorted vision at reading distance.
Subjects also completed a set of questionnaires detailing their satisfaction levels, adaptation times, and preferences for Test or Control spectacles for different visual tasks.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Berkeley, California, United States, 94720-2020
- Clinical Research Center, School of Optometry, University of California, Berkeley
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
39 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Presbyope
- Experienced PAL spectacle wearer
- Correctable to at least 20/25 in both eyes
- Able and willing to use Test and Control spectacles for 1 week each as primary form of presbyopia correction
- Able and willing to complete all laboratory measurements and questionnaire batteries
Exclusion Criteria:
- Purchasing free-form PAL spectacles from the UC Berkeley Eyewear Center
- Having eye conditions or diseases that could potentially cause a decrease in visual acuity over the course of participation in the study
- Having eye conditions or diseases that could potentially interfere with ability to use Test and Control spectacles as primary form of presbyopia correction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Randomized Order of Interventions 1
Randomized to first wear standard, non-free-form, non-customized PAL spectacles, then second, crossover to wear individually customized free-form surfaced PAL spectacles
|
Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Other Names:
|
Active Comparator: Randomized Order of Interventions 2
Randomized to first wear individually customized free-form surfaced PAL spectacles, then second, crossover to wear standard, non-free-form, non-customized PAL spectacles
|
Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity, High Contrast, Distance Chart
Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Visual Acuity, Low Contrast, Distance Chart
Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Visual Acuity, High Contrast, Near Chart
Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Visual Acuity, Low Contrast, Near Chart
Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
30-degree Off-axis Distance Visual Acuity, High Contrast Chart
Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
30-degree Off-axis Distance Visual Acuity, Low Contrast Chart
Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Horizontal Extent of Undistorted Vision at Reading Distance
Time Frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Questionnaire Battery
Time Frame: At study exit, after both Test and Control spectacles had been worn for 1 week each
|
Forced-choice Likert scale preference questionnaire
|
At study exit, after both Test and Control spectacles had been worn for 1 week each
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Meng C. Lin, OD, PhD, Clinical Research Center, School of Optometry, University of California, Berkeley
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
November 3, 2010
First Submitted That Met QC Criteria
November 3, 2010
First Posted (Estimate)
November 4, 2010
Study Record Updates
Last Update Posted (Actual)
April 18, 2017
Last Update Submitted That Met QC Criteria
April 17, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CZV_PAL1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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