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| Name | Class |
|---|---|
| Carl Zeiss Meditec, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Order of Interventions 1 | Active Comparator | 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 Order of Interventions 2 | Active Comparator | Randomized to first wear individually customized free-form surfaced PAL spectacles, then second, crossover to wear standard, non-free-form, non-customized PAL spectacles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard, non-free-form, non-customized PAL spectacles | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng C. Lin, OD, PhD | Clinical Research Center, School of Optometry, University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, School of Optometry, University of California, Berkeley | Berkeley | California | 94720-2020 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21217408 | Result | 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. |
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95 subjects were recruited, all of whom met the eligibility criteria and completed the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Control Spectacles Worn First, Then Test Spectacles | Crossover trial; 2 arms: subjects randomized to wear Control spectacles 1st, then Test spectacles 2nd |
| FG001 | Group 2 - Test Spectacles Worn First, Then Control Spectacles | Crossover trial; 2 arms: subjects randomized to wear Test spectacles 1st, then Control spectacles 2nd |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| 1-Week Washout Period |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Crossover trial: all study participants received both Test and Control spectacles, in randomized order. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | logMAR | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles |
|
9 months (study duration)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Spectacles | Arm/Groups Adverse Events are reported "per intervention" |
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Possibility of insufficient head immobilization during off-axis VA measurement on left side only for some subjects. May explain difference of off-axis VA results between right and left sides.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew D. Graham | UCaliforniaBerkeley | 510-643-9252 | agraham@berkeley.edu |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Individually customized free-form surfaced PAL spectacles | Device | 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 |
|
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| 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 |
| 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 |
| Questionnaire Battery | Forced-choice Likert scale preference questionnaire | At study exit, after both Test and Control spectacles had been worn for 1 week each |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Arm/Groups Outcome Measures are reported "per intervention". |
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | logMAR | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles |
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|
|
| 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. | 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 | Posted | Mean | Standard Deviation | logMAR | 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. | 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 | Posted | Mean | Standard Deviation | logMAR | 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 | 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 | Posted | Mean | Standard Deviation | logMAR | 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 | 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 | Posted | Mean | Standard Deviation | logMAR | 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 | 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 | Posted | Mean | Standard Deviation | cm | 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 | 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 | Posted | Number | percentage of participants | At study exit, after both Test and Control spectacles had been worn for 1 week each |
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|
| 0 |
| 95 |
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | Test Spectacles | Arm/Groups Adverse Events are reported "per intervention" | 0 | 95 | 0 | 95 | 0 | 95 |
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| Preference for Active Vision |
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| Preference for Midrange Vision |
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| Preference for Transitional Vision |
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| Preference for Near Vision |
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