Effect of Lens Presentation on the Clinical Oculomotor Assessment at Near

NCT ID: NCT02679313

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-09-30

Brief Summary

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This study will compare near clinical oculomotor parameters (heterophoria, vergence ranges, AC/A and accommodative findings) measured when lenses and/or prisms are introduced using three different instruments namely: (i) a standard manual phoropter, (ii) an electronic phoropter and (iii) a wearable adaptive refractor (VisionFit).

Detailed Description

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Previous studies have demonstrated differences in a number of near oculomotor parameters \[e.g., heterophoria, accommodative convergence to accommodation (AC/A) ratio\] when measured in a manual phoropter versus a trial frame. These differences may be due to variations in proximal vergence, differences in head and eye position and restriction of the peripheral visual field. Further, a number of standard clinical oculomotor procedures require the use of Risley rotary prisms. While prism is typically introduced in a smooth, ramp-like fashion with manual phoropters, step changes in prism are created with electronic phoropters. The precise effect of these variations on clinical measurements is unclear. Accordingly, after a routine refractive examination, a standard clinical near assessment (comprising near heterophoria, AC/A ratio, horizontal vergence ranges, amplitude of accommodation and negative and positive relative accommodation) will be carried out on the same individuals through: (i) a standard manual phoropter (American Optical model 11625), (ii) an electronic phoropter (Topcon CV-5000) and (iii) a wearable adaptive refractor (VisionFit). The latter resembles a trial frame mounted on a helmet carrier (similar to a binocular indirect ophthalmoscope headset) but includes adaptive lenses that can be changed electronically.

Conditions

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Vision Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Study Groups

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Phoropter

Each subject will be tested on 3 separate occasions using either the manual phoropter (American Optical 11625), electronic phoropter (Topcon CV-5000) or the wearable adaptive refractor (VisionFit).

Group Type EXPERIMENTAL

Phoropter

Intervention Type DEVICE

Each subject will be tested on 3 separate occasions using either the manual phoropter (American Optical 11625), electronic phoropter (Topcon CV-5000) or the wearable adaptive refractor (VisionFit). Oculomotor measurements, i.e., heterophoria, vergence ranges, AC/A and accommodative findings will be measured at each session using the different devices. Each session will be separated by a minimum of 24 hours and a maximum of 14 days.

Interventions

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Phoropter

Each subject will be tested on 3 separate occasions using either the manual phoropter (American Optical 11625), electronic phoropter (Topcon CV-5000) or the wearable adaptive refractor (VisionFit). Oculomotor measurements, i.e., heterophoria, vergence ranges, AC/A and accommodative findings will be measured at each session using the different devices. Each session will be separated by a minimum of 24 hours and a maximum of 14 days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Corrected visual acuity of at least 20/20 (logMAR = 0.0) or better in each eye

Exclusion Criteria

* Strabismus, amblyopia, manifest ocular disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York College of Optometry

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Rosenfield, MCOptom, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York College of Optometry

Locations

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SUNY College of Optometry

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Phoropter Study

Identifier Type: -

Identifier Source: org_study_id

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