PresbyopiaCZV_PAL1NCT01234207
Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
A study testing Standard, non-free-form, non-customized PAL spectacles and Individually customized free-form surfaced PAL spectacles in people with Presbyopia, run by University of California, Berkeley at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 39 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Standard, non-free-form, non-customized PAL spectacles and Individually customized free-form surfaced PAL spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, School of Optometry, University of California, Berkeley
Berkeley, California, 94720-2020
About this study
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.
Read the 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
- Being tested
- Standard, non-free-form, non-customized PAL spectacles, Individually customized free-form surfaced PAL spectacles
- Keywords
- Progressive addition lenses, Customized free-form, Presbyopia, Bifocals, Subjective assessment, Visual performance, Visual acuity, Amsler grid
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard, non-free-form, non-customized PAL spectaclesDevice
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 spectaclesDevice
Also called Zeiss Individual, Carl Zeiss Vision, Inc., Germany
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Standard, non-free-form, non-customized PAL spectacles; Device: 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 Receives: Device: Standard, non-free-form, non-customized PAL spectacles; Device: Individually customized free-form surfaced PAL spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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
Measured: 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
Measured: 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
Measured: At study exit, after both Test and Control spectacles had been worn for 1 week each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Responsible party
- Principal investigator, Meng C. Lin, University of California, Berkeley
- Investigators
- Meng C. Lin, OD, PhD, Principal investigator, Clinical Research Center, School of Optometry, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234207
- Sponsor's protocol ID
- CZV_PAL1
- Acronym
- CZV_PAL1
- Status last verified
- Apr 2017
- First submitted
- 3 Nov 2010
- Last updated
- 18 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21217408
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
- ClinicalTrials.gov ID
- NCT01234207
- Acronym / sponsor ID
- CZV_PAL1 / CZV_PAL1
- Conditions
- Presbyopia
- Keywords
- Progressive addition lenses, Customized free-form, Presbyopia, Bifocals, Subjective assessment, Visual performance, Visual acuity, Amsler grid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Order of Interventions 1 | Active comparator | Device: Standard, non-free-form, non-customized PAL spectacles, Device: Individually customized free-form surfaced PAL spectaclesRandomized 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 | Device: Standard, non-free-form, non-customized PAL spectacles, Device: Individually customized free-form surfaced PAL spectaclesRandomized to first wear individually customized free-form surfaced PAL spectacles, then second, crossover to wear standard, non-free-form, non-customized PAL spectacles |
Who may qualify
- Ages
- 39 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard, non-free-form, non-customized PAL spectaclesControl 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 | Randomized Order of Interventions 1, Randomized Order of Interventions 2 |
| Individually customized free-form surfaced PAL spectaclesAlso: Zeiss Individual, Carl Zeiss Vision, Inc., GermanyTest 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 | Device | Randomized Order of Interventions 1, Randomized Order of Interventions 2 |
Primary outcome
Visual Acuity, High Contrast, Distance Chart
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid
Questionnaire Battery
Time frame: At study exit, after both Test and Control spectacles had been worn for 1 week each
Forced-choice Likert scale preference questionnaire
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21217408Han 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng C. Lin, OD, PhD principal investigator
Clinical Research Center, School of Optometry, University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard, non-free-form, non-customized PAL spectacles and Individually customized free-form surfaced PAL spectacles in people with Presbyopia, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity, High Contrast, Distance Chart (time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.