UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041009 |
|---|---|
| Receipt number | R000046744 |
| Scientific Title | Assessment of Functional Visual Acuity in Patients with Blepharospasm |
| Date of disclosure of the study information | 2020/07/06 |
| Last modified on | 2021/01/20 13:53:00 |
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Basic information
Public title
Assessment of Functional Visual Acuity in Patients with Blepharospasm
Acronym
Functional Visual Acuity in Blepharospasm
Scientific Title
Assessment of Functional Visual Acuity in Patients with Blepharospasm
Scientific Title:Acronym
Functional Visual Acuity in Blepharospasm
Region
| Japan |
Condition
Condition
blepharospasm
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluate functional visual acuity in patients with blepharospasm
Basic objectives2
Others
Basic objectives -Others
evaluate functional visual acuity by comparing patients with blepharospasm and control subjects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
functional visual acuity
Key secondary outcomes
visual acuity, subjective manifest refraction, intraocular pressure, assessment of corneal epithelial fluorescein staining (NEI score), tear film break up time (BUT), dry eye questionnaire-5 (DEQ-5), blepharospasm disability index (BSDI), Jancovic rating scale (JRS)
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with primary and drug induced blepharospasm
The control group is consist of patients without blepharospasm and receiving none of treatment
Best corrected visual acuity of each eyes is 1.0 and more
Key exclusion criteria
1) Symptomatic eyelid spasm
Patients with a history of Parkinson's disease, progressive supranuclear palsy, etc.
2) History of botulinum toxin treatment within 6 months prior to survey.
3) Patients with systemic neuromuscular junction disorders.
Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.
4) Patients with cerebrovascular disease with paralysis
5) Patients with facial nerve palsy
6) Patients with glaucoma or ocular hypertension under treatment
7) Patients with active uveitis
8) Patients with corneal and conjunctival diseases, excluding dry eyes
9) Patients with macular diseases (e.g. age-related macular degeneration, epiretinal membrane, etc.)
10) Patients with retinal diseases (e.g., retinal vascular disorder, retinitis pigmentosa, myopic changes, etc.)
11)Patients with intense myopia greater than -6D
12) Other patients who are deemed inappropriate by the physician, such as those with systemic or ophthalmic diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Miyata |
Organization
Miyata Eye Hospital
Division name
Medical Office
Zip code
885-0051
Address
6-3 Kurahara-cho, Miyakonojo-city, Miyazaki-prefecture, Japan
TEL
0986-22-1441
m.manabu.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Sakisaka |
Organization
Miyata Eye Hospital
Division name
Medical Office
Zip code
885-0051
Address
6-3 Kurahara-cho, Miyakonojo-city, Miyazaki-prefecture, Japan
TEL
0986-22-1441
Homepage URL
sakisaka@miyata-med.ne.jp
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Miyata Eye Hospital
Address
6-3 Kurahara-cho, Miyakonojo-city, Miyazaki-prefecture, Japan
Tel
0986-22-1441
ushihama@miyata-med.ne.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
宮田眼科病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 06 | 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
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objectives are examined at the entry.
Management information
Registered date
| 2020 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046744
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/01/10 | BS対コントロールの実用視力、研究実施計画書（2020.05.11）_0510YAGI.DOCX |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
