Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
CZV_PAL1
1 other identifier
interventional
95
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 3, 2010
CompletedFirst Posted
Study publicly available on registry
November 4, 2010
CompletedResults Posted
Study results publicly available
April 18, 2017
CompletedApril 18, 2017
April 1, 2017
8 months
November 3, 2010
June 27, 2013
April 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Visual Acuity, High Contrast, Distance Chart
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
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
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
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
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
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
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
Forced-choice Likert scale preference questionnaire
At study exit, after both Test and Control spectacles had been worn for 1 week each
Study Arms (2)
Randomized Order of Interventions 1
ACTIVE COMPARATORRandomized to first wear standard, non-free-form, non-customized PAL spectacles, then second, crossover to wear individually customized free-form surfaced PAL spectacles
Randomized Order of Interventions 2
ACTIVE COMPARATORRandomized to first wear individually customized free-form surfaced PAL spectacles, then second, crossover to wear standard, non-free-form, non-customized PAL spectacles
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Berkeleylead
- Carl Zeiss Meditec, Inc.collaborator
Study Sites (1)
Clinical Research Center, School of Optometry, University of California, Berkeley
Berkeley, California, 94720-2020, United States
Related Publications (1)
Han SC, Graham AD, Lin MC. Clinical assessment of a customized free-form progressive add lens spectacle. Optom Vis Sci. 2011 Feb;88(2):234-43. doi: 10.1097/OPX.0b013e31820846ac.
PMID: 21217408RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Possibility of insufficient head immobilization during off-axis VA measurement on left side only for some subjects. May explain difference of off-axis VA results between right and left sides.
Results Point of Contact
- Title
- Andrew D. Graham
- Organization
- UCaliforniaBerkeley
Study Officials
- PRINCIPAL INVESTIGATOR
Meng C. Lin, OD, PhD
Clinical Research Center, School of Optometry, University of California, Berkeley
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Research Center
Study Record Dates
First Submitted
November 3, 2010
First Posted
November 4, 2010
Study Start
February 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
April 18, 2017
Results First Posted
April 18, 2017
Record last verified: 2017-04