UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042495 |
|---|---|
| Receipt number | R000048511 |
| Scientific Title | Evaluation of night vision support glasses (HOYA MW10 HiKARI) in patients with diabetic retinopathy after panretinal photocoagulation surgery |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2020/11/18 18:43:59 |
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Basic information
Public title
A study of the usefulness of night vision support glasses in laser-treated diabetic retinopathy patients
Acronym
Usefulness of night vision support glasses in laser-treated diabetic retinopathy patients
Scientific Title
Evaluation of night vision support glasses (HOYA MW10 HiKARI) in patients with diabetic retinopathy after panretinal photocoagulation surgery
Scientific Title:Acronym
Usefulness ofnight vision support glasses in patients with diabetic retinopathy after panretinal photocoagulation surgery
Region
| Japan |
Condition
Condition
Diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of the HOYA MW10 (HOYA MW10 HiKARI) on visual function in dark places in diabetic patients after pan-retinal photocoagulation (PRP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corrected visual acuity before and after wearing MW10 in the dark place
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
control
Interventions/Control_2
patients with diabetic retinopathy
Interventions/Control_3
patients with diabetic retinopathy after PRP
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Those who are 20 years of age or older at the time of obtaining consent
2 Those who are able to visit or see the outpatient clinic of Shinshu University Hospital on the designated date
3 Those who have obtained the patient's voluntary written consent to participate in this study
4 Selection criteria for each group
PRP group, Patients diagnosed with diabetic retinopathy and treated with PRP.
5 PRP naive group, diabetic retinopathy diagnosed and not on PRP.
6 Healthy group, healthy volunteers with no eye disease and corrected visual acuity of 1.0 or better in the clearing
Key exclusion criteria
Those who are deemed unsuitable as a research subject by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Hirano |
Organization
Shinshu University School of Medicine
Division name
Department of ophthalmology
Zip code
390-8621
Address
Asahi 3-1-1 Matsumoto Nagano
TEL
+81-263-37-2664
takaoh@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Hirano |
Organization
Shinshu University School of Medicine
Division name
Department of ophthalmology
Zip code
390-8621
Address
Asahi 3-1-1 Matsumoto Nagano
TEL
+81-263-37-2664
Homepage URL
takaoh@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
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
Shinshu University School of Medicine
Address
Asahi 3-1-1 Matsumoto Nagano
Tel
+81-263-37-2664
takaoh@shinshu-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
| 2020 | Year | 11 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 11 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048511
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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