Refractive ErrorsNCT03222661
Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction
An observational study of Refractive Errors, run by Smart Vision Labs at 1 site in United States.
Trial summary
The purpose of the study is to compare the final glasses prescription based on refraction obtained with SVOne device to the final prescription obtained via subjective manifest refraction. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Refraction
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2017to Nov 2017
- 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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Population with refractive error between -14.00 to +14.00 diopter of spherical error and astigmatism up to -7.00 diopters.
Who may be able to join
- Subjects must be 12 (under 18 with parental consent) years of age and older up to 65 years of age.
- No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.
Who cannot join
- Refractive error greater than +/- 14.00 diopters, or astigmatism greater than -7.00 diopters.
- Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
- Best corrected visual acuity with spectacles of 20/25 or worse.
- Any previous surgical or laser procedures that may limit BCVA
- 11 years of age and younger
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Rosa Pham & Associates
Houston, Texas, 77056
Tihomira Petkova, OD, PhD, 713-963-0021, tihomira.p@me.com
Tihomira Petkova, OD, PhD
About this study
The purpose of the study is to compare the final glasses prescription based on refraction obtained with SVOne device to the final prescription obtained via subjective manifest refraction.
Read the detailed description
Uncorrected refractive error is the leading cause of vision impairment and the second leading cause of blindness worldwide, affecting 1 in 90 individuals (1). In the US population approximately 14 million individuals aged 12 years or older have visual impairment (defined as distance visual acuity of 20/50 or worse), of which more than 11 million individuals (2) could have their vision improved to 20/40 or better with refractive correction.
Uncorrected refractive error impacts all aspects of life, including, but not limited to, loss of employment opportunities, inability to care for family, and inability to receive an education. SVOne is smartphone-based autorefractor, powered by wavefront aberrometry, due to its portability and accuracy it presents as an effective and accessible method of detecting refractive error and dispensing spectacles for better vision (3).
In this study, for each patient, a single clinician will determine final prescription through manifest refraction, while a different clinician will determine final prescription using SVOne exam protocol. Sphere, cylinder and axis will be converted to power vectors and compared by linear regression analysis.
- Conditions
- Refractive Errors
- Being tested
- Refraction
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RefractionDiagnostic test
Refractive error measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Sphere, cylinder and axis measurement for each patient
the outcome includes sphere, cylinder and axis measurement (in diopter) by using both SVOne wave-guided autorefractor and subjective manifest refraction
Measured: 4 months
Comparison of two measurements on the same patient
the outcome will include comparison of two sphere, cylinder and axis measurements (in power vectors) for each patient obtained with SVOne wave-guided autorefractor and subjective manifest refraction.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startSep 2017 (estimated)
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Vision Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222661
- Sponsor's protocol ID
- SVOne01
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Naidoo KS, Leasher J, Bourne RR, Flaxman SR, Jonas JB, Keeffe J, Limburg H, Pesudovs K, Price H, White RA, Wong TY, Taylor HR, Resnikoff S; Vision Loss Expert Group of the Global Burden of Disease Study. Global Vision Impairment and Blindness Due to Uncorrected Refractive Error, 1990-2010. Optom Vis Sci. 2016 Mar;93(3):227-34. doi: 10.1097/OPX.0000000000000796.
PubMed 26905537Vitale S, Cotch MF, Sperduto RD. Prevalence of visual impairment in the United States. JAMA. 2006 May 10;295(18):2158-63. doi: 10.1001/jama.295.18.2158.
PubMed 16684986Ciuffreda KJ, Rosenfield M. Evaluation of the SVOne: A Handheld, Smartphone-Based Autorefractor. Optom Vis Sci. 2015 Dec;92(12):1133-9. doi: 10.1097/OPX.0000000000000726.
PubMed 26540478
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction
- ClinicalTrials.gov ID
- NCT03222661
- Acronym / sponsor ID
- SVOne01
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Smart Vision LabsIndustry (pharma, biotech, devices)
- Study start
- Sep 2017 (estimated)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 19 Jul 2017 (actual)
- 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.
The purpose of the study is to compare the final glasses prescription based on refraction obtained with SVOne device to the final prescription obtained via subjective manifest refraction.
Detailed description
Uncorrected refractive error is the leading cause of vision impairment and the second leading cause of blindness worldwide, affecting 1 in 90 individuals (1). In the US population approximately 14 million individuals aged 12 years or older have visual impairment (defined as distance visual acuity of 20/50 or worse), of which more than 11 million individuals (2) could have their vision improved to 20/40 or better with refractive correction.
Uncorrected refractive error impacts all aspects of life, including, but not limited to, loss of employment opportunities, inability to care for family, and inability to receive an education. SVOne is smartphone-based autorefractor, powered by wavefront aberrometry, due to its portability and accuracy it presents as an effective and accessible method of detecting refractive error and dispensing spectacles for better vision (3).
In this study, for each patient, a single clinician will determine final prescription through manifest refraction, while a different clinician will determine final prescription using SVOne exam protocol. Sphere, cylinder and axis will be converted to power vectors and compared by linear regression analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population with refractive error between -14.00 to +14.00 diopter of spherical error and astigmatism up to -7.00 diopters.
Key inclusion criteria (2 listed)
- Subjects must be 12 (under 18 with parental consent) years of age and older up to 65 years of age.
- No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.
Key exclusion criteria (5 listed)
- Refractive error greater than +/- 14.00 diopters, or astigmatism greater than -7.00 diopters.
- Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
- Best corrected visual acuity with spectacles of 20/25 or worse.
- Any previous surgical or laser procedures that may limit BCVA
- 11 years of age and younger
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 |
|---|---|---|
| RefractionRefractive error measurement | Diagnostic test | – |
Primary outcome
Sphere, cylinder and axis measurement for each patient
Time frame: 4 months
the outcome includes sphere, cylinder and axis measurement (in diopter) by using both SVOne wave-guided autorefractor and subjective manifest refraction
Comparison of two measurements on the same patient
Time frame: 4 months
the outcome will include comparison of two sphere, cylinder and axis measurements (in power vectors) for each patient obtained with SVOne wave-guided autorefractor and subjective manifest refraction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 26905537Naidoo KS, Leasher J, Bourne RR, Flaxman SR, Jonas JB, Keeffe J, Limburg H, Pesudovs K, Price H, White RA, Wong TY, Taylor HR, Resnikoff S; Vision Loss Expert Group of the Global Burden of Disease Study. Global Vision Impairment and Blindness Due to Uncorrected Refractive Error, 1990-2010. Optom Vis Sci. 2016 Mar;93(3):227-34. doi: 10.1097/OPX.0000000000000796.
- Background: PubMed 16684986Vitale S, Cotch MF, Sperduto RD. Prevalence of visual impairment in the United States. JAMA. 2006 May 10;295(18):2158-63. doi: 10.1001/jama.295.18.2158.
- Background: PubMed 26540478Ciuffreda KJ, Rosenfield M. Evaluation of the SVOne: A Handheld, Smartphone-Based Autorefractor. Optom Vis Sci. 2015 Dec;92(12):1133-9. doi: 10.1097/OPX.0000000000000726.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by Smart Vision Labs 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tihomira Petkova, OD, PhD (832-202-4780, tihomira.p@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sphere, cylinder and axis measurement for each patient (time frame: 4 months). The study lists 2 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 NCT03222661, which also lists 3 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 19 Jul 2017.