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

This study has been completed.
Sponsor:
Collaborator:
Carl Zeiss Vision, Inc., Germany
Information provided by:
University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT01234207
First received: November 3, 2010
Last updated: June 21, 2011
Last verified: November 2010
  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 Phase
Presbyopia
Device: Standard, non-free-form, non-customized PAL spectacles
Device: Individually customized free-form surfaced PAL spectacles
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 University of California, Berkeley:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Horizontal extent of undistorted vision at reading distance [ Time Frame: At dispensing and post-1 week of wear for Test and Control spectacles ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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)
Intervention Details:
    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 randomized, 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. 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
Genders Eligible for Study:   Both
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
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 Vision, Inc., Germany
Investigators
Principal Investigator: Meng C. Lin, OD, PhD Clinical Research Center, School of Optometry, University of California, Berkeley
  More Information

No publications provided

Responsible Party: Meng C. Lin, OD, PhD, FAAO, Clinical Research Center, School of Optometry, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT01234207     History of Changes
Other Study ID Numbers: CZV_PAL1
Study First Received: November 3, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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 April 17, 2014