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Effect of Lens Presentation on the Clinical Oculomotor Assessment at Near

Primary Purpose

Vision Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phoropter
Sponsored by
State University of New York College of Optometry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vision Disorders

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SUNY College of Optometry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phoropter

Arm Description

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).

Outcomes

Primary Outcome Measures

Near horizontal heterophoria
Near horizontal heterophoria (measured in prism diopters) will be recorded using both the Von Graefe and Modified Thorington techniques using each of the three lens presentation devices. The single set of measurements will be recorded approximately 15 minutes after the start of the trial.
Accommodative convergence to accommodation (AC/A) ratio
The AC/A ratio will be calculated from measurements of near horizontal heterophoria (quantified in prism diopters) will be recorded using the Modified Thorington technique at 3 different accommodative stimulus levels (1.5D, 2.5D and 3.5D). Measurements will be obtained using each of the three lens presentation devices and calculated in units of prism diopter per diopter accommodation.The single set of measurements will be recorded approximately 15 minutes after the start of the trial.
Horizontal near vergence ranges
Near base-in and base-out vergence ranges will be measured (in prism diopters) while the subject fixates a near target. Measurements will be expressed in terms of the blur point, break point and recovery measurement .The single set of measurements will be recorded approximately 15 minutes after the start of the trial.
Minus lens amplitude of accommodation
Minus lens amplitude of accommodation (measured in diopters) will be recorded using each of the three lens presentation devices.The single set of measurements will be recorded approximately 15 minutes after the start of the trial.

Secondary Outcome Measures

Negative and Positive Relative Accommodation (NRA and PRA)
NRA and PRA (measured in diopters) will be recorded using each of the three lens presentation devices.The single set of measurements will be recorded approximately 15 minutes after the start of the trial.

Full Information

First Posted
February 1, 2016
Last Updated
May 16, 2017
Sponsor
State University of New York College of Optometry
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1. Study Identification

Unique Protocol Identification Number
NCT02679313
Brief Title
Effect of Lens Presentation on the Clinical Oculomotor Assessment at Near
Official Title
Effect of Lens Presentation on the Clinical Oculomotor Assessment at Near
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York College of Optometry

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phoropter
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Phoropter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Near horizontal heterophoria
Description
Near horizontal heterophoria (measured in prism diopters) will be recorded using both the Von Graefe and Modified Thorington techniques using each of the three lens presentation devices. The single set of measurements will be recorded approximately 15 minutes after the start of the trial.
Time Frame
approximately 15 minutes
Title
Accommodative convergence to accommodation (AC/A) ratio
Description
The AC/A ratio will be calculated from measurements of near horizontal heterophoria (quantified in prism diopters) will be recorded using the Modified Thorington technique at 3 different accommodative stimulus levels (1.5D, 2.5D and 3.5D). Measurements will be obtained using each of the three lens presentation devices and calculated in units of prism diopter per diopter accommodation.The single set of measurements will be recorded approximately 15 minutes after the start of the trial.
Time Frame
approximately 15 minutes
Title
Horizontal near vergence ranges
Description
Near base-in and base-out vergence ranges will be measured (in prism diopters) while the subject fixates a near target. Measurements will be expressed in terms of the blur point, break point and recovery measurement .The single set of measurements will be recorded approximately 15 minutes after the start of the trial.
Time Frame
approximately 15 minutes
Title
Minus lens amplitude of accommodation
Description
Minus lens amplitude of accommodation (measured in diopters) will be recorded using each of the three lens presentation devices.The single set of measurements will be recorded approximately 15 minutes after the start of the trial.
Time Frame
approximately 15 minutes
Secondary Outcome Measure Information:
Title
Negative and Positive Relative Accommodation (NRA and PRA)
Description
NRA and PRA (measured in diopters) will be recorded using each of the three lens presentation devices.The single set of measurements will be recorded approximately 15 minutes after the start of the trial.
Time Frame
approximately 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Rosenfield, MCOptom, PhD
Organizational Affiliation
State University of New York College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Lens Presentation on the Clinical Oculomotor Assessment at Near

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