Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJuly 19, 2017
July 1, 2017
2 months
July 10, 2017
July 17, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
4 months
Interventions
Refractive error measurement
Eligibility Criteria
Population with refractive error between -14.00 to +14.00 diopter of spherical error and astigmatism up to -7.00 diopters.
You may qualify if:
- 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.
You may not qualify if:
- 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
- years of age and younger
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Rosa Pham & Associates
Houston, Texas, 77056, United States
Related Publications (3)
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.
PMID: 26905537BACKGROUNDVitale 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.
PMID: 16684986BACKGROUNDCiuffreda 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.
PMID: 26540478BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2017
First Posted
July 19, 2017
Study Start
September 1, 2017
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
July 19, 2017
Record last verified: 2017-07