AccommodationNCT03557346
Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions
An observational study of Accommodation, run by Chung-Ang University Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Accommodation
- What is being tested?
- the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan)
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2017to 31 Mar 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects who visited the department of ophthalmology in Chung-Ang university hospital for ocular examination
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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.
Read the 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).
- Conditions
- Accommodation
- Being tested
- the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodative power
Accommodative powers in diopters were measured using WAM-5500 binocular autorefractor/keratometer
Measured: 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
Measured: 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.
Measured: Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start2 Jan 2017
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AccommodationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Hyun Park, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557346
- Sponsor's protocol ID
- CAUHOphthalmology
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30686953
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions
- ClinicalTrials.gov ID
- NCT03557346
- Acronym / sponsor ID
- CAUHOphthalmology
- Conditions
- Accommodation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects who visited the department of ophthalmology in Chung-Ang university hospital for ocular examination
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Derived from this study: PubMed 30686953Park 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Accommodation, run by Chung-Ang University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.