UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021354
Receipt number R000024627
Scientific Title Effects of divergence on near visual function
Date of disclosure of the study information 2016/03/15
Last modified on 2019/09/10 16:14:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of divergence on near visual function

Acronym

Effects of divergence on near visual function

Scientific Title

Effects of divergence on near visual function

Scientific Title:Acronym

Effects of divergence on near visual function

Region

Japan


Condition

Condition

Visually healthy adult volunteers

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of divergence on near visual function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Objective refraction

Key secondary outcomes

1. Near binocular visual acuity
2. The rate of variability of pupil diameter
3. The presence or absence of blurred vision


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Divergence eye movement with base-in prisms.
The subjects were induced into 4 degrees of esophoria (0~2, 4, 8, 10~16 prism E) by putting the base-in prism. We investigate the objective refraction, near binocular visual acuity, pupil diameter, subjective symptom, while the subjects fuse an accommodative target at near fixation in each degree of esophoria. Prism wearing time of each stage is about 10 minutes. Measurement time is about 45 minutes in total.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

Visually healthy young subjects who have corrected visual acuity 1.0 or better without ocular diseases.

Key exclusion criteria

Volunteers who have hyperopia, manifest strabismus, intermittent exotropia, post-refractive surgery.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Ishiko

Organization

Asahikawa Medical University

Division name

Department of Medicine and Engineering Combined Research Institute

Zip code

078-8510

Address

2-1-1 Midorigaoka, Higashi

TEL

+81166682543

Email

nnori@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Nishikawa

Organization

Asahikawa Medical University

Division name

Department of ophthalmology

Zip code

078-8510

Address

Midorigaoka Higashi 2-Jo 1-Chome, Asahikawa, Hokkaido

TEL

0166-68-2543

Homepage URL


Email

nnori@asahikawa-med.ac.jp


Sponsor or person

Institute

Department of ophthalmology
Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahikawa Medical University Research Ethics Committee

Address

Midorigaoka Higashi 2-Jo 1-Chome, Asahikawa, Hokkaido

Tel

0166-68-2187

Email

rs-kk.g@asahikawa-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 15 Day


Related information

URL releasing protocol

https://doi.org/10.11476/shinkeiganka.35.357

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.11476/shinkeiganka.35.357

Number of participants that the trial has enrolled

17

Results

Difference in the accommodative lag was observed significantly 0 PD E and 10-12 PD E. A correlation was observed between the angle of esophoria and the NBVA, and between the accommodative lag and the NBVA. There was no correlation between the angle of esophoria and the rate of VPD.As the degree of divergence amplitude increased, the accommodative lag increased, and the near binocular visual function decreased.

Results date posted

2019 Year 09 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

All participants were volunteers.

Participant flow

Seventeen participants were healthy volunteers
with no ophthalmological disease other than refractive errors.

Adverse events

Nothing

Outcome measures

The objective refraction, the pupil diameter,
near visual acuity with wearing base in prisms.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 03 Month 07 Day

Date of IRB

2016 Year 02 Month 22 Day

Anticipated trial start date

2016 Year 03 Month 15 Day

Last follow-up date

2017 Year 03 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 05 Day

Last modified on

2019 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024627


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name