Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions
June 4, 2018 updated by: Hong Hyun Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
The investigators believe that this simple, clear, and objective study may be a great help in understanding the accommodative response during various accommodative stimulation conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose in this study was to investigate physiological changes in accommodative power, pupil diameter, astigmatic value, and axis when visual stimuli were applied under binocular, monocular (dominant eye, non-dominant eye, ipsilateral, and contralateral), and pinhole conditions using the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan).
Study Type
Observational
Enrollment (Actual)
64
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects who visited the department of ophthalmology in Chung-Ang university hospital for ocular examination
Description
Inclusion Criteria:
- age between 20 and 40 years
- spherical equivalent (SE) within ± 4.0 diopters (D)
- correctable distant and near visual acuity by glasses to 20/20
- normal ocular alignment.
Exclusion Criteria:
- disturbance of accommodation (e.g., Adie's pupil, Parkinson's disease, accommodative esotropia, accommodative spasm, presbyopia)
- disorders that can affect accommodation (e.g., history of ocular trauma, previous ocular surgery)
- disorders that might limit testing accuracy (e.g., corneal pathological features, cataract, glaucoma, vitreous opacity, and retinal abnormalities).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accommodative power
Time Frame: Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
|
Accommodative powers in diopters were measured using WAM-5500 binocular autorefractor/keratometer
|
Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
|
|
Pupil diameter
Time Frame: Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
|
Pupil diameters in millimeters were measured using WAM-5500 binocular autorefractor/keratometer
|
Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
|
|
Astigmatic value and axis change
Time Frame: Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
|
Astigamtic value in diopters and axis change in degrees were measured using WAM-5500 binocular autorefractor/keratometer The spherical equivalent (sphere + 1/2 cylinder) was used to assess the response to refractive stimuli.
The principal meridian of the cylinder for 0.25D refractive stimulus was set to the baseline axis.
For 2D, 3D, and 4D refractive stimuli, vertical movement was determined when the baseline meridian moved to the 90' axis, and it was considered horizontal movement when it moved to the 0' or 180' axis.
|
Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2017
Primary Completion (Actual)
March 31, 2017
Study Completion (Actual)
March 31, 2017
Study Registration Dates
First Submitted
May 22, 2018
First Submitted That Met QC Criteria
June 4, 2018
First Posted (Actual)
June 15, 2018
Study Record Updates
Last Update Posted (Actual)
June 15, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CAUHOphthalmology
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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