UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046924 |
|---|---|
| Receipt number | R000052781 |
| Scientific Title | Development and clinical application of an optical mouse detection device for the treatment of amblyopia caused by congenital nystagmus, sway vision in acquired nystagmus, and reduction of diplopia in acquired strabismus |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/02/18 09:02:27 |
* 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
Development and clinical application of an optical mouse detection device for the treatment of amblyopia caused by congenital nystagmus, sway vision in acquired nystagmus, and reduction of diplopia in acquired strabismus
Acronym
Development and clinical application of an optical mouse detection device for the treatment of amblyopia caused by congenital nystagmus, sway vision in acquired nystagmus, and reduction of diplopia in acquired strabismus
Scientific Title
Development and clinical application of an optical mouse detection device for the treatment of amblyopia caused by congenital nystagmus, sway vision in acquired nystagmus, and reduction of diplopia in acquired strabismus
Scientific Title:Acronym
Development and clinical application of an optical mouse detection device for the treatment of amblyopia caused by congenital nystagmus, sway vision in acquired nystagmus, and reduction of diplopia in acquired strabismus
Region
| Japan |
Condition
Condition
Congenital nystagmus, acquired nystagmus, strabismus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By providing a mechanical and optical mechanism to correct nystagmus, this research aims to suppress the developmental disturbance of the visual cortex in children and to reduce perturbation and diplopia in acquired nystagmus and strabismus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An optical mouse detection system (self-made optical device) will be loaned to the participants, and they will be trained to wear it for 3 hours a day at home. Training will be conducted for 30 days, and the patient will be asked to visit the ophthalmology outpatient clinic after 30 days. After that, the training and ophthalmology outpatient visits will be repeated, and a 6-month study will be conducted to evaluate the visual function.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjective Evaluation Questionnaire and Reading Time Measurement Using an Optical Mouse Detection System.
An optical mouse detection system was applied to eyes with strabismus and nystagmus, and distant landscapes and near vertical and horizontal reading strings were read out loud. In addition, to measure the reading speed in the near, the time was measured before and after wearing the device. The scale was judged by three patterns of vertical and horizontal reading at distance and near, respectively, and by the comfort level (1. very uncomfortable, 2. somewhat uncomfortable, 3. nothing in particular, 4. somewhat comfortable, 5. very comfortable) and the readability level (1. very easy to see, 2. somewhat easy to see, 3. neither easy nor hard to see, 4. somewhat hard to see). It is very easy to see, 2. somewhat easy to see, 3. neither easy nor hard to see, 4. somewhat hard to see, 5. very hard to see, and 1. very shaky, 2. somewhat shaky, 3. nothing in particular. The time required for answering the question, including the evaluation after wearing the product, was five minutes.
Interventions/Control_2
Visual function training using an optical mouse detection system.
Participants will be loaned an optical mouse detection system and trained to wear it for 3 hours a day at home. Training will be conducted for 30 days, and patients will be asked to visit the ophthalmology outpatient clinic after 30 days. After that, the training and ophthalmology outpatient visits will be repeated, and a 6-month study will be conducted to evaluate the visual function.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects will be those who are undergoing treatment for strabismus and nystagmus at Kitasato University Hospital. In Stage 1, the subjects must be 20 years of age or older and present with strabismus or nystagmus. Patients must be aware of diplopia or agitation due to strabismus or nystagmus. Stage 2: Patients under the age of 9 years with nystagmus who have not shown improvement in visual function through training in the usual medical care. Each study will include 20 cases. Exclusion criteria will be as follows. Patient recruitment will be done directly to the patient in Stage 1, and directly to the child's parents in Stage 2.
Key exclusion criteria
Exclusion Criteria for Stage 1
Previous external eye surgery for strabismus or nystagmus
Pregnant women who are at least 5 months old before the examination
Exclusion criteria for stage 2
Previous or planned external eye surgery for strabismus or nystagmus
Patients with corneal or retinal diseases other than nystagmus that cause poor vision.
Patients with functional amblyopia, etc., who are expected to improve their visual function with visual function training within the scope of regular medical care.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takushi |
| Middle name | |
| Last name | Kawamorita |
Organization
Kitasato University School of Allied Health Sciences
Division name
Depertment of Orthoptics and Visual Science
Zip code
2520373
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, JAPAN
TEL
042-778-9662
kawa2008@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takushi |
| Middle name | |
| Last name | Kawamorita |
Organization
Kitasato University School of Allied Health Sciences
Division name
Depertment of Orthoptics and Visual Science
Zip code
2520373
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, JAPAN
TEL
042-778-9662
Homepage URL
kawa2008@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Allied Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, JAPAN
Tel
042-778-9662
kawa2008@kitasato-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
| 2022 | Year | 04 | Month | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052781
