Back to results

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

Primary Purpose

Presbyopia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Individually customized free-form surfaced PAL spectacles

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Progressive addition lenses, Customized free-form, Presbyopia, Bifocals, Subjective assessment, Visual performance, Visual acuity, Amsler grid

Eligibility Criteria

39 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Randomized Order of Interventions 1

Randomized Order of Interventions 2

Arm 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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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

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

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

Questionnaire Battery

Forced-choice Likert scale preference questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT01234207

First Posted

November 3, 2010

Last Updated

April 17, 2017

Sponsor

University of California, Berkeley

Collaborators

Carl Zeiss Meditec, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01234207

Brief Title

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

Acronym

CZV_PAL1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Berkeley

Collaborators

Carl Zeiss Meditec, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyopia

Keywords

Progressive addition lenses, Customized free-form, Presbyopia, Bifocals, Subjective assessment, Visual performance, Visual acuity, Amsler grid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Randomized Order of Interventions 1

Arm Type

Active Comparator

Arm 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

Arm Title

Randomized Order of Interventions 2

Arm Type

Active Comparator

Arm 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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Individually customized free-form surfaced PAL spectacles

Other Intervention Name(s)

Zeiss Individual, Carl Zeiss Vision, Inc., Germany

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Acuity, High Contrast, Distance Chart

Description

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.

Time Frame