Clinical Investigation of the Vision-R800 Device.

NCT ID: NCT04208750

Last Updated: 2022-03-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-02-01

Brief Summary

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Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.

Detailed Description

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Conditions

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Myopia Hyperopia Astigmatism Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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R-Refraction

Group Type EXPERIMENTAL

Vision R-800 Phoropter

Intervention Type DEVICE

Refraction utilizing the Vision R-800 Phoropter with resulting glasses

Standard Phoropter

Intervention Type DEVICE

Refraction utilizing the standard phoropter with resulting glasses

S-Refraction

Group Type ACTIVE_COMPARATOR

Vision R-800 Phoropter

Intervention Type DEVICE

Refraction utilizing the Vision R-800 Phoropter with resulting glasses

Standard Phoropter

Intervention Type DEVICE

Refraction utilizing the standard phoropter with resulting glasses

Interventions

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Vision R-800 Phoropter

Refraction utilizing the Vision R-800 Phoropter with resulting glasses

Intervention Type DEVICE

Standard Phoropter

Refraction utilizing the standard phoropter with resulting glasses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* current adaptated progressive addition lens wearer, if bifocal lens required
* wearable pair of glasses \< 2 years old
* wear glasses at least 6 hours per day

Exclusion Criteria

* Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report)
* Formal training in optometry, vision science or in the eyecare field
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pete Kollbaum, OD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Pete Kollbaum, OD, PhD

Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Indiana University Clinical Optics Research Lab

Bloomington, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Kollbaum003

Identifier Type: -

Identifier Source: org_study_id

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