UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044731 |
|---|---|
| Receipt number | R000051087 |
| Scientific Title | Treatment of amblyopia with atropine |
| Date of disclosure of the study information | 2021/07/02 |
| Last modified on | 2026/07/06 16:22:38 |
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Basic information
Public title
Treatment of amblyopia with atropine
Acronym
Atropine treatment
Scientific Title
Treatment of amblyopia with atropine
Scientific Title:Acronym
Atropine treatment
Region
| Japan |
Condition
Condition
amblyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of atropine treatment for amblyopia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 2 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
who can do visual acuity test
Key exclusion criteria
atropin allergey
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kiuchi |
Organization
Hiroshima University Hospital
Division name
ophthalmology
Zip code
7348551
Address
Hiroshima city Minami-ku Kasumi 1-2-3
TEL
0822575247
ykiuchi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Komatsu |
Organization
Hiroshima University Hospital
Division name
Ophthalmology
Zip code
7348551
Address
Hiroshima city Minami-ku Kasumi 1-2-3
TEL
0822575247
Homepage URL
kaori110@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital
Address
Hiroshima city Minami-ku Kasumi 1-2-3
Tel
0822575907
iryo-seisaku@office.hiroshima-u.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
| 2021 | Year | 07 | Month | 02 | 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
7
Results
Of the 7 participants, 2 dropped out during the study; 4 had a final corrected visual acuity of 1.0 or higher, and 1 had a final corrected visual acuity of less than 1.0.
The reason for the lack of improvement in visual acuity was that the treatment was administered after residual membrane formation.
Results date posted
| 2026 | Year | 07 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Because we were unable to gather enough case studies.
Date of the first journal publication of results
Baseline Characteristics
The children were aged 4 to 6, and the gender ratio was 6:1, with more girls than boys. The main causes of low vision were strabismus (4 children), anisometropia (3 children), and form deprivation (1 child).
Participant flow
The final results for 2 of the 7 participants are unknown because they discontinued their treatment.
Adverse events
1 person with photophobia.
Outcome measures
Refraction, Visual Acuity, Intraocular Pressure, Eye Alignment, Stereopsis
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation period is 2years
Management information
Registered date
| 2021 | Year | 07 | Month | 01 | Day |
Last modified on
| 2026 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051087
