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OpenTrials
Completed

NCT Number: NCT03557346

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

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.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan)

Device

: 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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Chung-Ang University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2018
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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