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

Presbyopia Clinical Trial

— CZV_PAL1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234207
• Other study ID #: CZV_PAL1
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: April 17, 2017
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: April 2017
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 39 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Clinical Research Center, School of Optometry, University of California, Berkeley	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	Carl Zeiss Meditec, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity, High Contrast, Distance Chart	Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.	Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Primary	Visual Acuity, Low Contrast, Distance Chart	Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.	Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Primary	Visual Acuity, High Contrast, Near Chart	Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.	Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Primary	Visual Acuity, Low Contrast, Near Chart	Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.	Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Primary	30-degree Off-axis Distance Visual Acuity, High Contrast Chart	Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart	Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Primary	30-degree Off-axis Distance Visual Acuity, Low Contrast Chart	Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart	Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Primary	Horizontal Extent of Undistorted Vision at Reading Distance	Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid	Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Primary	Questionnaire Battery	Forced-choice Likert scale preference questionnaire	At study exit, after both Test and Control spectacles had been worn for 1 week each