Effect of Lens Presentation on the Clinical Oculomotor Assessment at Near

NCT02679313 | Withdrawn

• 1 other identifier: Phoropter Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Vision Disorders

Outcome Measures

Primary Outcomes (4)

• 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.

  approximately 15 minutes

• 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.

  approximately 15 minutes

• 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.

  approximately 15 minutes

• 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.

  approximately 15 minutes

Secondary Outcomes (1)

• Negative and Positive Relative Accommodation (NRA and PRA)

  approximately 15 minutes

Study Arms (1)

Phoropter

EXPERIMENTAL

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).

Device: Phoropter

Interventions

Phoropter 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.

Phoropter

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Strabismus, amblyopia, manifest ocular disease.

Sponsors & Collaborators

• State University of New York College of Optometry: lead

Study Sites (1)

SUNY College of Optometry

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Rosenfield, MCOptom, PhD

  State University of New York College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 10, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)