UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038890 |
|---|---|
| Receipt number | R000044341 |
| Scientific Title | Study of complications and disease developed after vitrectomy |
| Date of disclosure of the study information | 2019/12/21 |
| Last modified on | 2019/12/15 14:46:32 |
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Basic information
Public title
Study of complications and disease developed after vitrectomy
Acronym
Study of complications and disease developed after vitrectomy
Scientific Title
Study of complications and disease developed after vitrectomy
Scientific Title:Acronym
Study of disease developed after vitrectomy
Region
| Japan |
Condition
Condition
retinal detachment, epiretinal membrane, macular hole, diabetic retinopathy, proliferative vitreoretiopathy, retinal vein occlusion.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose and significance of research (outline)
The purpose of this study is to analyze cases of disease after vitrectomy. Our university has one of the largest number of vitreous surgery cases in the country, and the data is managed as a database. However, vitreous surgery always has the risk of not being able to improve visual function due to post-operative complications and post-surgical diseases, and there is currently no knowledge about the risk factors. Therefore, in this study, we will retrospectively examine cases in which postoperative disease has occurred among the cases that have undergone vitreous surgery.
Basic objectives2
Others
Basic objectives -Others
To investigate the onset rate and the risk factors, progression of epiretinal membrane and macular hole after Rhegmatogenous retinal detachment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
At pre operation and one year after post operation
Medical history, treatment history, occurrence of side effects, visual acuity, intraocular pressure, surgical articles, laser flare cell meter, OCT image, OPTOS image, and other ophthalmic examination items.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all patients underwent vitrectomy in our hospital
from January 2008 to Jun 2019.
Key exclusion criteria
Patients underwent vitrectomy before. Not primary vitrectomy cases.
Target sample size
3200
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Horiguchi |
Organization
Fujita Health University of Medicine.
Division name
ophthalmology
Zip code
4701192
Address
1-98, Dengakugakubo, Kutukake-cho, Toyoake city, Aichi prefecture, Japan.
TEL
0562932097
masayuki@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Mizuguchi |
Organization
Fujita Health University of Medicine.
Division name
ophthalmology
Zip code
4701192
Address
1-98, Dengakugakubo, Kutukake-cho, Toyoake city, Aichi prefecture, Japan.
TEL
0562932097
Homepage URL
mizu@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University of Medicine.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
study support promotion office.
Address
1-98, Dengakugakubo, Kutukake-cho, Toyoake city, Aichi prefecture, Japan.
Tel
0562932862
kenshien@fujita-hu.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
藤田医科大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 21 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Participants and method
Among the 3548 eyes, a traction component that causes RD (proliferative diabetic diabetic), which was performed for the repair of RRD from 1 January 2008 to 28 February 2019 at Fujita Medical University Hospital History of retinopathy and proliferative vitreoretinopathy, BRVO, trauma, etc., previous RD surgery including MHRD, giant tear RRD, buckling, PPV with buckling, encircling, choroid detachment, and PPV with silicone oil tamponade Patients were excluded (2954 eyes). Of the 2954 eyes (2520), vitrectomy 2455 eyes (person) and buckle 499 eyes (469). We review the electronic medical records retrospectively for 1737 eyes (1697 patients) excluding vitrectomy2455 eyes, preoperative OCT, 117 eyes with ERM, 514 eyes that cannot be judged by OCT, and 87 eyes without preoperative OCT.
Use ophthalmoscopic fundus findings, fundus photography, and optical coherence tomography (OCT) to define ERM.
Six judges judged whether there was ERM by interpreting randomly assigned medical records, OCT images, and fundus photographs. If in doubt, the two persons in charge of interpretation interpret the results and adopt the matching results. Excluded are those that have not been OCT preoperatively, those that cannot be judged due to opacity of the intermediate translucent body due to vitreous hemorrhage, etc. To do.
Factors that required ERM removal surgery (ERM group) and those that did not require ERM surgery (non-ERM group) due to ERM formation after only PPV for initial RRD repair Compare and consider. Furthermore, we investigate the incidence of ERM peeling surgery and changes in corrected visual acuity before and after ERM surgery.
Management information
Registered date
| 2019 | Year | 12 | Month | 15 | Day |
Last modified on
| 2019 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044341
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