UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035354 |
|---|---|
| Receipt number | R000040249 |
| Scientific Title | Visual field changes after vitrectomy for macular diseases |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2023/12/28 09:13:39 |
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Basic information
Public title
Visual field changes after vitrectomy for macular diseases
Acronym
VF changes after vitrectomy
Scientific Title
Visual field changes after vitrectomy for macular diseases
Scientific Title:Acronym
VF changes after vitrectomy
Region
| Japan |
Condition
Condition
macular hole, epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate visual field changes after vitrectomy for macular disease. Also, we evaluate factors related to postoperative visual field changes.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual field changes 3, 6, 12, and 24 months after vitrectomy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Written informed consent: Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients.
(2) Eyes with epiretinal membrane or macular hole
Key exclusion criteria
1) History of disease which affect the visual field sensitivity except glaucoma, epiretinal membrane, and macular hole.
2) Patients with history of refractive surgery, vitreous surgery or retinal detachment surgery.
3)History of amblyopia (annisometropic amblyopia and refractive amblyopia)
4) Unable to perform visual field test.
5) Patients who were judged to be ineligible for this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Higashide |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Ophthalmology
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2403
eyetomo@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Higashide |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Ophthalmology
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2000
Homepage URL
eyetomo@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
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
Kanazawa University
Address
13-1 Takara-machi, Kanazawa, 9208641, Japan.
Tel
076-265-2090
rinri@adm.kanazawa-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
| 2019 | Year | 01 | 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
| 2011 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective cohort study consists of patients with epiretinal membrane or macular hole who meet the inclusion criteria and undergo visual field tests before and after vitrectomy in the Kanazawa University Hospital.
A part of the study participants were included as those for the retrospective cohort study.
Management information
Registered date
| 2018 | Year | 12 | Month | 24 | Day |
Last modified on
| 2023 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040249
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
