Trial Outcomes & Findings for Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle (NCT NCT01234207)

NCT ID: NCT01234207

Last Updated: 2017-04-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 95 participants
• Primary outcome timeframe: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
• Results posted on: 2017-04-18

Participant Flow

Presbyopic subjects were recruited from the population of patients who were purchasing non-free-form PAL spectacles with antireflective coating in new frames from the University of California, Berkeley School of Optometry Eyewear Center.

95 subjects were recruited, all of whom met the eligibility criteria and completed the study.

Participant milestones

Measure	Group 1 - Control Spectacles Worn First, Then Test Spectacles Crossover trial; 2 arms: subjects randomized to wear Control spectacles 1st, then Test spectacles 2nd	Group 2 - Test Spectacles Worn First, Then Control Spectacles Crossover trial; 2 arms: subjects randomized to wear Test spectacles 1st, then Control spectacles 2nd
First Intervention STARTED	47	48
First Intervention COMPLETED	47	48
First Intervention NOT COMPLETED	0	0
1-Week Washout Period STARTED	47	48
1-Week Washout Period COMPLETED	47	48
1-Week Washout Period NOT COMPLETED	0	0
Second Intervention STARTED	47	48
Second Intervention COMPLETED	47	48
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Study Participants n=95 Participants Crossover trial: all study participants received both Test and Control spectacles, in randomized order.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	58.1 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles

Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period

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.

Outcome measures

Measure	Control Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".	Test Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".
Visual Acuity, High Contrast, Distance Chart	-0.12 logMAR Standard Deviation 0.06	-0.11 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles

Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period

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.

Outcome measures

Measure	Control Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".	Test Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".
Visual Acuity, Low Contrast, Distance Chart	0.01 logMAR Standard Deviation 0.07	0.01 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles

Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period

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.

Outcome measures

Measure	Control Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".	Test Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".
Visual Acuity, High Contrast, Near Chart	-0.11 logMAR Standard Deviation 0.13	-0.09 logMAR Standard Deviation 0.09

PRIMARY outcome

Timeframe: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles

Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period

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.

Outcome measures

Measure	Control Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".	Test Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".
Visual Acuity, Low Contrast, Near Chart	0.05 logMAR Standard Deviation 0.09	0.12 logMAR Standard Deviation 0.64

PRIMARY outcome

Timeframe: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles

Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period

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

Outcome measures

Measure	Control Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".	Test Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".
30-degree Off-axis Distance Visual Acuity, High Contrast Chart Off-Axis Left	0.10 logMAR Standard Deviation 0.13	0.10 logMAR Standard Deviation 0.14
30-degree Off-axis Distance Visual Acuity, High Contrast Chart Off-Axis Right	0.05 logMAR Standard Deviation 0.09	0.04 logMAR Standard Deviation 0.10

PRIMARY outcome

Timeframe: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles

Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period

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

Outcome measures

Measure	Control Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".	Test Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".
30-degree Off-axis Distance Visual Acuity, Low Contrast Chart Off-Axis Left	0.24 logMAR Standard Deviation 0.12	0.24 logMAR Standard Deviation 0.12
30-degree Off-axis Distance Visual Acuity, Low Contrast Chart Off-Axis Right	0.19 logMAR Standard Deviation 0.10	0.16 logMAR Standard Deviation 0.11

PRIMARY outcome

Timeframe: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles

Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period

Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid

Outcome measures

Measure	Control Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".	Test Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".
Horizontal Extent of Undistorted Vision at Reading Distance	17.74 cm Standard Deviation 9.87	20.06 cm Standard Deviation 11.89

PRIMARY outcome

Timeframe: At study exit, after both Test and Control spectacles had been worn for 1 week each

Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period

Forced-choice Likert scale preference questionnaire

Outcome measures

Measure	Control Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".	Test Spectacles n=95 Participants Arm/Groups Outcome Measures are reported "per intervention".
Questionnaire Battery Overall Preference	45 percentage of participants	55 percentage of participants
Questionnaire Battery Preference for Distance Vision	40 percentage of participants	60 percentage of participants
Questionnaire Battery Preference for Active Vision	40 percentage of participants	60 percentage of participants
Questionnaire Battery Preference for Midrange Vision	45 percentage of participants	55 percentage of participants
Questionnaire Battery Preference for Transitional Vision	45 percentage of participants	55 percentage of participants
Questionnaire Battery Preference for Near Vision	50 percentage of participants	50 percentage of participants

Adverse Events

Control Spectacles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Spectacles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew D. Graham

UCaliforniaBerkeley

Phone: 510-643-9252

Email: agraham@berkeley.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place