UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024626
Receipt number R000028320
Scientific Title The attempt of treatment for refractory amblyopia under binocular condition.
Date of disclosure of the study information 2016/10/29
Last modified on 2019/05/08 14:17:49

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Basic information

Public title

The attempt of treatment for refractory amblyopia under binocular condition.

Acronym

The attempt of treatment for refractory amblyopia under binocular condition.

Scientific Title

The attempt of treatment for refractory amblyopia under binocular condition.

Scientific Title:Acronym

The attempt of treatment for refractory amblyopia under binocular condition.

Region

Japan


Condition

Condition

anisometropic amblyopia and microtropic amblyopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to examine the visual acuity and binocular function improvement rate prospectively by binocular based amblyopia treatment with Bangerter filters placed over the non-amblyopic eye, to whom it was difficult to continue the intensive occlusion(eye patch) and/or topical drops of atropine penalization for the fellow eye.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual acuity, binocular function and contrast sensitivity at 2 months after binocular based amblyopia treatment.

Key secondary outcomes

visual acuity, binocular function and contrast sensitivity at 2 month after the treatment end.


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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Binocular based amblyopia treatment with Bangerter filters placed over the non-amblyopic eye.

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

3 years-old <=

Age-upper limit

10 years-old >=

Gender

Male and Female

Key inclusion criteria

1. The patients who have been diagnosed with anisometropic amblyopia or microtropic amblyopia.
2. The patients who could not continue intensive occlusion therapy and/or topical drops of atropine penalization treatment for the fellow eye.
3. The patients, despite of those treatment more than 6 months with excellent or good compliance, improvement of visual acuity was less than 1 line.
4.The patients who meet the following conditions, 1 and 2, or 1 and 3.

Key exclusion criteria

1. The patients who have ocular disease
other than amblyopia and strabismus.
2. The patients with systemic or
neurological disease affecting visual
function.
3. The patients who are prohibited
watching TV or video game for the
photo hypersensitive allergy.
4. The patients who were judged to be
unsuitable by research doctor.
5. The patients with one of these
conditions at least.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Furuse

Organization

Kawasaki Medical School General Medical Center

Division name

Department of Ophthalmology

Zip code

700-8505

Address

2-6-1 Nakasange, Kita-ku, Okayama 700-8505, Japan

TEL

0862252111

Email

tfuruse@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Furuse

Organization

Kawasaki Medical School General Medical Center

Division name

Department of Ophthalmology

Zip code

700-8505

Address

2-6-1 Nakasange, Kita-ku, Okayama 700-8505, Japan

TEL

0862252111

Homepage URL


Email

tfuruse@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Kawasaki Medical School Institutional Review Board

Address

577 Matsushima,Kurashikishi-City,Okayama

Tel

+81-86-462-1111

Email

kmsrec@med.kawasaki-m.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 10 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

10

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 10 Month 17 Day

Date of IRB

2016 Year 11 Month 22 Day

Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date

2018 Year 11 Month 21 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 10 Month 29 Day

Last modified on

2019 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028320


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name