Portable Autorefractor- InstaRef R20

Not yet recruiting

• Conditions: to assess refractive error

• Registration Number: CTRI/2021/11/037869
• Lead Sponsor: Diwakar Rao

Brief Summary

This is a Prospective Study, which is validating a Portable Autorefractor (InstaRef R20) comparing against Subjective refraction (gold standard),Open field AR, Plusoptix, Quciksee, Standard tabletop autorefractor Topcon ARK 800 and Cycloplegic refraction. This device uses a Shack Hartmann aberrometer technology, which is used to find a Refractive error,and has a distinct advantage of not only being affordable and portable but can also be used as a standalone device.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-11
• Last Update Posted: 2021-12-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 132

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

Name	Time	Method
Demonstrate the performance of InstaRef R20 when compared against subjective refraction (gold standard).	At the end of the study

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sankara Eye Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sankara Eye Hospital

🇮🇳Bangalore, KARNATAKA, India

Diwakar Rao

Principal investigator

9972015862

dot_diwakar@yahoo.co.in