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

University of California (UC), Berkeley

Status: Completed

Conditions: Presbyopia

Treatments: Device: Standard, non-free-form, non-customized PAL spectacles; Device: Individually customized free-form surfaced PAL spectacles

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01234207

CZV_PAL1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 39 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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95 participants in 2 patient groups

Randomized Order of Interventions 1

Active Comparator group

Description:

Randomized to first wear standard, non-free-form, non-customized PAL spectacles, then second, crossover to wear individually customized free-form surfaced PAL spectacles

Treatment:

Device: Individually customized free-form surfaced PAL spectacles

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

Randomized Order of Interventions 2

Active Comparator group

Description:

Randomized to first wear individually customized free-form surfaced PAL spectacles, then second, crossover to wear standard, non-free-form, non-customized PAL spectacles

Treatment:

Device: Individually customized free-form surfaced PAL spectacles

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