Clinical trial NCT01234207: Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
Official title: Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Progressive addition lenses
Customized free-form
Presbyopia
Bifocals
Subjective assessment
Visual performance
Visual acuity
Amsler grid
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Carl Zeiss Meditec, Inc.
First posted: 2010-11-04
Enrollment: 95
Sex: ALL
Minimum age (years): 39
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Acuity, High Contrast, Distance Chart
timeFrame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
measure: Visual Acuity, Low Contrast, Distance Chart
timeFrame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
measure: Visual Acuity, High Contrast, Near Chart
timeFrame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
measure: Visual Acuity, Low Contrast, Near Chart
timeFrame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
measure: 30-degree Off-axis Distance Visual Acuity, High Contrast Chart
timeFrame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
measure: 30-degree Off-axis Distance Visual Acuity, Low Contrast Chart
timeFrame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
measure: Horizontal Extent of Undistorted Vision at Reading Distance
timeFrame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
measure: Questionnaire Battery
timeFrame: At study exit, after both Test and Control spectacles had been worn for 1 week each
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, School of Optometry, University of California, Berkeley
state: California
Study officials:
affiliation: Clinical Research Center, School of Optometry, University of California, Berkeley
name: Meng C. Lin, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.