MedPath

Portable Autorefractor- InstaRef R20

Not Applicable
Registration Number
CTRI/2021/11/037869
Lead Sponsor
Diwakar Rao
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Subjects with BCVA 20/20 in each eye.

Subjects with refractive errors between Sph+/-10D, Cyl +/-5D.

Exclusion Criteria

Subjects with significant media opacity- corneal opacity, advanced cataract, vitreous hemorrhage. posterior segment pathology affecting visual acuity, amblyopia and inability to fixate, active eye infection, inflammation.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Demonstrate the performance of InstaRef R20 when compared against subjective refraction (gold standard). <br/ ><br>Timepoint: At the end of the study <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
Demonstrate the substantial equivalence in terms of performance and safety of a InstaRef R20 in measuring refractive errors when compared against a Open field AR, Plusoptic, Quicksee and standard tabletop autorefractor Topcon ARK 800. <br/ ><br>Timepoint: At the end of the trail
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