Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions

Accommodation Clinical Trial

Official title:

Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557346
• Other study ID #: CAUHOphthalmology
• Status: Completed
• Start date: January 2, 2017
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2018
• Source: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. age between 20 and 40 years

2. spherical equivalent (SE) within ± 4.0 diopters (D)

3. correctable distant and near visual acuity by glasses to 20/20

4. normal ocular alignment.

Exclusion Criteria:

1. disturbance of accommodation (e.g., Adie's pupil, Parkinson's disease, accommodative esotropia, accommodative spasm, presbyopia)

2. disorders that can affect accommodation (e.g., history of ocular trauma, previous ocular surgery)

3. disorders that might limit testing accuracy (e.g., corneal pathological features, cataract, glaucoma, vitreous opacity, and retinal abnormalities).

Related Conditions & MeSH terms

• Accommodation

Intervention

Device:
• the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan)
: Subjects underwent a basic ophthalmic examination and the accommodative response to refractive stimuli was measured. Refractive stimuli were given at 0.25 diopters (D) (4 m distance), 2D (50 cm), 3D (33 cm), and 4D (25 cm) and stimulation was applied with the eyes in binocular, monocular (dominant eye, non-dominant eye, ipsilateral, and contralateral), and pinhole conditions. In addition, changes in the astigmatic value and direction of the astigmatism axis under binocular stimulus were evaluated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accommodative power	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
Primary	Pupil diameter	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
Primary	Astigmatic value and axis change	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