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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
November 3, 2010
April 17, 2017
February 2009
October 2009   (Final data collection date for primary outcome measure)
  • 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
  • Visual Acuity, high and low contrast, distance and near charts [ Time Frame: At dispensing and post-1 week of wear for Test and Control spectacles ]
  • 30-degree off-axis visual acuity, high and low contrast, distance chart [ Time Frame: At dispensing and post-1 week of wear for Test and Control spectacles ]
  • Horizontal Extent of Undistorted Vision at Reading Distance [ Time Frame: At dispensing and post-1 week of wear for Test and 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 dispensing and post-1 week of wear for Test and Control spectacles ]
    Primary instrument assesses visual quality, visual comfort and awareness of having to locate the point of focus for different visual tasks, at different distances, and under different lighting conditions; other questionnaires for satisfaction, direct preference comparisons of Test v. Control, and adaptation time.
Complete list of historical versions of study NCT01234207 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Presbyopia
  • 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 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
    Interventions:
    • Device: Standard, non-free-form, non-customized PAL spectacles
    • Device: Individually customized free-form surfaced PAL spectacles
  • 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
    Interventions:
    • Device: Standard, non-free-form, non-customized PAL spectacles
    • Device: Individually customized free-form surfaced PAL spectacles
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
October 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
39 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01234207
CZV_PAL1
No
Not Provided
Not Provided
Meng C. Lin, University of California, Berkeley
University of California, Berkeley
Carl Zeiss Meditec, Inc.
Principal Investigator: Meng C. Lin, OD, PhD Clinical Research Center, School of Optometry, University of California, Berkeley
University of California, Berkeley
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP