Refractive ErrorNCT02028351
Vision Measured by the Vimetrics CVA Compared With Chart Testing Under Similar Luminance and Contrast Conditions
An observational study of Refractive Error and Cataract, run by Sinclair Technologies, LLC at 2 sites in 2 countries.
Trial summary
Purpose of The Study: The purpose of this study is the following: A)To gather age-related normative visual acuity data for the Vimetrics Central Vision Analyzer (CVA, Vimetrics, LLC, Media, Pa) B)To gather visual acuity data for patients with known ocular problems, including cataract and maculopathy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error, Cataract, Maculopathy
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Eye Clinic
General Exclusion Criteria:
those individuals whom the examiner determines cannot read the ETDRS letter chart to define vision and those individuals whom the examiner determines cannot respond to the computer presentation of the tumbled Landolt C by pressing one of the 4 buttons arranged in a diamond or by deflecting the joystick on the response pad held in the lap.
Normals:
Systemic Disease Exclusion Criteria: Persons with systemic disease that would interfere with vision will be excluded under the normal classification. Such diseases that would exclude a subject from this category would include diabetes, and other systemic diseases such as neurological disorders that the examiner determines may interfere with the vision of an eye.
Ocular Inclusion criteria:
For inclusion in the normal group an eye would have an ocular examination within three months that, in the least, included the following:
A visual acuity measured of 20/30 or better for which on examination the refractive error alone is determined to define the vision.
For individuals 65 years or greater, lens nuclear opalescence and brunescence that is less than or equal to NO3, NC3 according to the LOCS III grading system.
For individuals less than 65 years, lens nuclear opalescence and brunescence that is less than or equal to NO2, NC2, according to the LOCS III grading system.
Ocular Exclusion Criteria:
Media opacity or retinal or optic nerve pathology that the examiner determines would affect the measured vision.
For individuals aged 65 or greater, eyes with nuclear opalescence and brunescence, according to the LOCS III grading system greater than NO3, NC3 or with other opacities will be excluded.
Eyes with Cataracts:
General Inclusion Criteria:
Persons without systemic disease that would interfere with vision will be enrolled. Such diseases that would exclude a subject from this category would include diabetes, and other systemic diseases such as neurological disorders that the examiner determines may interfere with the vision of an eye.
Ocular Inclusion Criteria:
For inclusion an eye would have had an ocular examination within three months as per the stated protocol.
A visual acuity worse than 20/30. The determination on examination by the examiner that the lens opacity alone defines the vision. For individuals less than age 65 the nuclear cataract will be denser than NO2, NC2 or contain other components (posterior cortical or posterior sub capsular) that will be documented. For individuals 65 years of age or older, the nuclear cataract will be greater than NO3, NC3 or contain other components that define the vision.
Ocular Exclusion Criteria:
Eyes in which retinal or optic nerve pathology that the examiner determines would affect the measured vision.
Eyes with a best refracted chart acuity of 20/100 or worse because in such eyes the examiner will be prevented by the media opacity from adequately examining the fundus to determine if there is co-existent macular pathology.
Eyes with Maculopathy:
General Inclusion Criteria:
It is recognized that many individuals within this group will have diabetes or hypertension that may be the cause of the maculopathy or aggravate the maculopathy. However, such systemic diseases will not necessarily exclude such persons, unless the examiner determines that such diseases cause reduced vision in the eye that is not defined by the maculopathy.
Ocular Inclusion Criteria:
For inclusion an eye would have had an ocular examination within three months with components according to the protocol as stated.
A visual acuity with chart testing worse than 20/30 for which on examination the maculopathy alone is determined to define the vision.
Ocular Exclusion Criteria:
Eyes with a chart acuity of 20/400 or worse. Eyes having lens or optic nerve pathology that the examiner determines would affect the measured vision.
Eyes with dense cataract in which an adequate examination of the macula is prevented.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Pennsylvania College of Optometry
Elkins Park, Pennsylvania, 19027
About this study
Official title: Comparison of Vision Measured by the Vimetrics Central Vision Analyzer With That Measured by logMAR Acuity Chart Testing Under Similar Conditions of Luminance and Contrast
Purpose of The Study:
The purpose of this study is the following:
A)To gather age-related normative visual acuity data for the Vimetrics Central Vision Analyzer (CVA, Vimetrics, LLC, Media, Pa) B)To gather visual acuity data for patients with known ocular problems, including cataract and maculopathy.
C)To correlate and compare the CVA visual acuity findings with the acuity measured with standard LogMAR acuity charts viewed under similar conditions of contrast and lighting
Read the detailed description
The measurement of visual acuity involves the determination of the smallest high contrast target that can be resolved by the patient. Classically, this has been approached by the use of letter style optotypes, each having successively smaller stroke and gap resolution. More recently, the arrangements of letter charts have been redesigned with a logarithmic scale and with attention being paid to the uniformity of other effects such as crowding or of the choice of optotype. The resultant Ferris-Bailey-Lovie chart has become a standard for acuity testing, especially for clinical research. The letters of such acuity charts have a 0.1 logMAR step progression (1.26 X) between lines and have 5 letters per line. It has been noted that the logMAR chart could have greater resolution with finer steps between the lines and with improved repeatability by converting to a letter-by-letter scoring system.
While these advances have improved the resolution and reliability of acuity measures, they require relatively cumbersome wall charts and do not provide any of the advantages of an interactive program that would enable a threshold to be approached by stimulus presentation on both the seeing as well as non-seeing sides.
The Vimetrics CVA is an interactive computer device that measures threshold visual acuity by presenting a Landolt-C with the gap randomly tumbled in one of 4 positions to which the patient responds with a response pad. The threshold is approached in a logarithmic, staircase fashion to define the test subject's acuity threshold with a resolution similar to letter by letter scoring in chart testing but with the ability to rapidly test under a number of conditions of luminance and contrast that simulate activities of daily living.
The CVA determination of visual acuity under six conditions of contrast and lighting will be compared with that acquired by logMAR chart testing under similar conditions.
- Conditions
- Refractive Error, Cataract, Maculopathy
- Keywords
- visual acuity, contrast sensitivity, cataract, maculopathy
- Medical subject headings
- Refractive Errors, Cataract, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | No Intervention | |
| Cataract | No intervention | |
| Maculopathy | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of monocular Visual Acuity
Measured: Upon recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinclair Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Stephen H. Sinclair, MD, Sinclair Technologies, LLC
- Investigators
- Stephen H Sinclair, MD, Principal investigator, Sinclair Technologies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028351
- Sponsor's protocol ID
- VVS 001
- Status last verified
- Jan 2014
- First submitted
- 29 Dec 2012
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arditi A, Cagenello R. On the statistical reliability of letter-chart visual acuity measurements. Invest Ophthalmol Vis Sci. 1993 Jan;34(1):120-9.
PubMed 8425819Bourne RR, Rosser DA, Sukudom P, Dineen B, Laidlaw DA, Johnson GJ, Murdoch IE. Evaluating a new logMAR chart designed to improve visual acuity assessment in population-based surveys. Eye (Lond). 2003 Aug;17(6):754-8. doi: 10.1038/sj.eye.6700500.
PubMed 12928690Hazel CA, Elliott DB. The dependency of logMAR visual acuity measurements on chart design and scoring rule. Optom Vis Sci. 2002 Dec;79(12):788-92. doi: 10.1097/00006324-200212000-00011.
PubMed 12512687Raasch TW, Bailey IL, Bullimore MA. Repeatability of visual acuity measurement. Optom Vis Sci. 1998 May;75(5):342-8. doi: 10.1097/00006324-199805000-00024.
PubMed 9624699Bailey IL. New procedures for detecting early vision losses in the elderly. Optom Vis Sci. 1993 Apr;70(4):299-305. doi: 10.1097/00006324-199304000-00008.
PubMed 8502458Carkeet A. Modeling logMAR visual acuity scores: effects of termination rules and alternative forced-choice options. Optom Vis Sci. 2001 Jul;78(7):529-38. doi: 10.1097/00006324-200107000-00017.
PubMed 11503943
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vision Measured by the Vimetrics Central Vision Analyzer With That Measured by logMAR Acuity Chart Testing Under Similar Conditions of Luminance and Contrast
- ClinicalTrials.gov ID
- NCT02028351
- Acronym / sponsor ID
- VVS 001
- Conditions
- Refractive Error, Cataract, Maculopathy
- Keywords
- visual acuity, contrast sensitivity, cataract, maculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sinclair Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of The Study:
The purpose of this study is the following:
A)To gather age-related normative visual acuity data for the Vimetrics Central Vision Analyzer (CVA, Vimetrics, LLC, Media, Pa) B)To gather visual acuity data for patients with known ocular problems, including cataract and maculopathy.
C)To correlate and compare the CVA visual acuity findings with the acuity measured with standard LogMAR acuity charts viewed under similar conditions of contrast and lighting
Detailed description
The measurement of visual acuity involves the determination of the smallest high contrast target that can be resolved by the patient. Classically, this has been approached by the use of letter style optotypes, each having successively smaller stroke and gap resolution. More recently, the arrangements of letter charts have been redesigned with a logarithmic scale and with attention being paid to the uniformity of other effects such as crowding or of the choice of optotype. The resultant Ferris-Bailey-Lovie chart has become a standard for acuity testing, especially for clinical research. The letters of such acuity charts have a 0.1 logMAR step progression (1.26 X) between lines and have 5 letters per line. It has been noted that the logMAR chart could have greater resolution with finer steps between the lines and with improved repeatability by converting to a letter-by-letter scoring system.
While these advances have improved the resolution and reliability of acuity measures, they require relatively cumbersome wall charts and do not provide any of the advantages of an interactive program that would enable a threshold to be approached by stimulus presentation on both the seeing as well as non-seeing sides.
The Vimetrics CVA is an interactive computer device that measures threshold visual acuity by presenting a Landolt-C with the gap randomly tumbled in one of 4 positions to which the patient responds with a response pad. The threshold is approached in a logarithmic, staircase fashion to define the test subject's acuity threshold with a resolution similar to letter by letter scoring in chart testing but with the ability to rapidly test under a number of conditions of luminance and contrast that simulate activities of daily living.
The CVA determination of visual acuity under six conditions of contrast and lighting will be compared with that acquired by logMAR chart testing under similar conditions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –No Intervention |
| Cataract | – | –No intervention |
| Maculopathy | – | –No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Eye Clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of monocular Visual Acuity
Time frame: Upon recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
- Background: PubMed 8425819Arditi A, Cagenello R. On the statistical reliability of letter-chart visual acuity measurements. Invest Ophthalmol Vis Sci. 1993 Jan;34(1):120-9.
- Background: PubMed 12928690Bourne RR, Rosser DA, Sukudom P, Dineen B, Laidlaw DA, Johnson GJ, Murdoch IE. Evaluating a new logMAR chart designed to improve visual acuity assessment in population-based surveys. Eye (Lond). 2003 Aug;17(6):754-8. doi: 10.1038/sj.eye.6700500.
- Background: PubMed 12512687Hazel CA, Elliott DB. The dependency of logMAR visual acuity measurements on chart design and scoring rule. Optom Vis Sci. 2002 Dec;79(12):788-92. doi: 10.1097/00006324-200212000-00011.
- Background: PubMed 9624699Raasch TW, Bailey IL, Bullimore MA. Repeatability of visual acuity measurement. Optom Vis Sci. 1998 May;75(5):342-8. doi: 10.1097/00006324-199805000-00024.
- Background: PubMed 8502458Bailey IL. New procedures for detecting early vision losses in the elderly. Optom Vis Sci. 1993 Apr;70(4):299-305. doi: 10.1097/00006324-199304000-00008.
- Background: PubMed 11503943Carkeet A. Modeling logMAR visual acuity scores: effects of termination rules and alternative forced-choice options. Optom Vis Sci. 2001 Jul;78(7):529-38. doi: 10.1097/00006324-200107000-00017.
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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.
Stephen H Sinclair, MD principal investigator
Sinclair Technologies, LLC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Error and Cataract, run by Sinclair Technologies, LLC at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of monocular Visual Acuity (time frame: Upon recruitment). 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 NCT02028351, which also lists 6 linked publications.
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 7 Jan 2014; AzTrials last refreshed its copy on 28 Oct 2026.