Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle - Full Text View

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:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

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:

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 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 May 16, 2013

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