UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008111 |
|---|---|
| Receipt number | R000009543 |
| Scientific Title | Assessment of the area of inner and outer segments of the photoreceptors junction line defect by new analysis method in idiopathic macular hole |
| Date of disclosure of the study information | 2012/06/07 |
| Last modified on | 2013/06/06 16:02:00 |
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Basic information
Public title
Assessment of the area of inner and outer segments of the photoreceptors junction line defect by new analysis method in idiopathic macular hole
Acronym
Assessment of the area of inner and outer segments of the photoreceptors junction line defect by new analysis method
Scientific Title
Assessment of the area of inner and outer segments of the photoreceptors junction line defect by new analysis method in idiopathic macular hole
Scientific Title:Acronym
Assessment of the area of inner and outer segments of the photoreceptors junction line defect by new analysis method
Region
| Japan |
Condition
Condition
Idiopathic macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study were to determine the new analysis method of evaluate the area of inner and outer segments of the photoreceptors (IS/OS) junction line defect using spectral domain optical coherence tomography, and to study the relationship between restoration of the area of IS/OS junction line defect and visual recovery after MH surgery, and more, to determined the relation between the area of IS/OS junction line defect and the microperimetry-determined retinal sensitivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area of inner and outer segments of the photoreceptors junction line defect
Key secondary outcomes
Best-corrected visual acuity, Retinal sensitivity, Stability of visual fixation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with an idiopathic macular hole who were scheduled to under go vitrectomy.
Key exclusion criteria
Cases in which anatomical macular hole closure was not succesful after the vitrectomy are exclud. And, cases with any ocular diseases that could affect visual potential, such as diabetic retinopathy, macular degeneration, retinal detachment, glaucoma, are also exculd.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Shiaraga |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Ophthalmology
Zip code
Address
1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
087-891-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Fujiwara |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Ophthalmology
Zip code
Address
1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
087-891-2211
Homepage URL
atsushi@med.kagawa-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa 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
Address
Tel
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
香川大学医学部附属病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 07 | 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
| 2012 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is to determine the new method of evaluation of the area of inner and outer segments of the photoreceptors (IS/OS) junction line defect using spectral domain optical coherence tomography, and to study the relationship between restoration of the area of IS/OS junction line defect and visual recovery after macular hole surgery.
Management information
Registered date
| 2012 | Year | 06 | Month | 06 | Day |
Last modified on
| 2013 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009543
