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

NCT03557346 | Completed

• 1 other identifier: CAUHOphthalmology
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Accommodation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

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.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who visited the department of ophthalmology in Chung-Ang university hospital for ocular examination

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

Related Publications (1)

• Park H, Park IK, Shin JH, Chun YS. Objective Verification of Physiologic Changes during Accommodation under Binocular, Monocular, and Pinhole Conditions. J Korean Med Sci. 2019 Jan 21;34(4):e32. doi: 10.3346/jkms.2019.34.e32. eCollection 2019 Jan 28.

  PMID: 30686953 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 15, 2018
• Study Start: January 2, 2017
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE