NCT01234207

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: University of California, Berkeley · Academic / Other
• Sex: All
• Age: 39 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2010-11-04
• Last updated: 2017-04-18
• Results posted: 2017-04-18

Locations

1 site across 1 country: United States