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Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle (CZV_PAL1)

This study has been completed.
Sponsor:
Collaborator:
Carl Zeiss Meditec, Inc.
Information provided by (Responsible Party):
Meng C. Lin, University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT01234207
First received: November 3, 2010
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Presbyopia Device: Standard, non-free-form, non-customized PAL spectacles Device: Individually customized free-form surfaced PAL spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle

Resource links provided by NLM:


Further study details as provided by Meng C. Lin, University of California, Berkeley:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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

  • 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

  • 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


Enrollment: 95
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: 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.
Device: Individually customized free-form surfaced PAL spectacles
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 Name: Zeiss Individual, Carl Zeiss Vision, Inc., Germany
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
Device: 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.
Device: Individually customized free-form surfaced PAL spectacles
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 Name: Zeiss Individual, Carl Zeiss Vision, Inc., Germany

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.
  Eligibility

Ages Eligible for Study:   39 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01234207

Locations
United States, California
Clinical Research Center, School of Optometry, University of California, Berkeley
Berkeley, California, United States, 94720-2020
Sponsors and Collaborators
University of California, Berkeley
Carl Zeiss Meditec, Inc.
Investigators
Principal Investigator: Meng C. Lin, OD, PhD Clinical Research Center, School of Optometry, University of California, Berkeley
  More Information

Publications:
Responsible Party: Meng C. Lin, Director, Clinical Research Center, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT01234207     History of Changes
Other Study ID Numbers: CZV_PAL1
Study First Received: November 3, 2010
Results First Received: June 27, 2013
Last Updated: April 17, 2017

Keywords provided by Meng C. Lin, University of California, Berkeley:
Progressive addition lenses
Customized free-form
Presbyopia
Bifocals
Subjective assessment
Visual performance
Visual acuity
Amsler grid

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 27, 2017