UMIN-CTR Clinical Trial

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
Email	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
Email	mizu@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University of Medicine.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044341