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

NCT ID: NCT01234207

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-10-31

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.

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard, non-free-form, non-customized PAL spectacles

Intervention Type: DEVICE

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.

Individually customized free-form surfaced PAL spectacles

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Standard, non-free-form, non-customized PAL spectacles

Intervention Type: DEVICE

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.

Individually customized free-form surfaced PAL spectacles

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Zeiss Individual, Carl Zeiss Vision, Inc., Germany

Eligibility 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

• Minimum Eligible Age: 39 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carl Zeiss Meditec, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Meng C. Lin

Director, Clinical Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meng C. Lin, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center, School of Optometry, University of California, Berkeley

Locations

Clinical Research Center, School of Optometry, University of California, Berkeley

Berkeley, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21217408 (View on PubMed)

Other Identifiers

CZV_PAL1

Identifier Type: -

Identifier Source: org_study_id