UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028202 |
|---|---|
| Receipt number | R000031900 |
| Scientific Title | Predictive Factors of Surgical Outcomes in Vitrectomy for Myopic Traction Maculopathy |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2022/02/03 00:29:09 |
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Basic information
Public title
Predictive Factors of Surgical Outcomes in Vitrectomy for Myopic Traction Maculopathy
Acronym
Surgical outcomes of MTM
Scientific Title
Predictive Factors of Surgical Outcomes in Vitrectomy for Myopic Traction Maculopathy
Scientific Title:Acronym
Surgical outcomes of MTM
Region
| Japan |
Condition
Condition
Myopic Traction Maculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study multifaceted factors predicting surgical outcome of myopic traction maculopathy, which is a preliminary stage of macular hole and macular hole retinal detachment, which causes remarkable visual acuity loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sex, age, visual acuity, visual field, refraction, corneal curvature radius, corneal thickness, ocular axial length, fundus observation,Optical coherence tomography, optical coherence tomography angiography, fundus photograph, fluorescence fundus angiography, slit lamp microscopy, duration of disease, current medical history, past history, family history, Surgical method
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent vitreous surgery for myopic telangiectasia from June 1, 2003 to December 31, 2015
Key exclusion criteria
nothing special
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kataoka |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2275
kkeiko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kataoka |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
Keiko
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2275
Homepage URL
kkeiko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2973
ethics@med.nagoya-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
| 2017 | Year | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2017 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031900
