UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Histopathological analyses of the membrane tissues on the optic disc in patients with optic disc pit-maculopathy (ODP-M).
Title of the study (Brief title)	Histopathological analyses of the membrane tissues on the optic disc in ODP-M.
Region	Japan

Condition
Condition	optic disc pit-maculopathy morning glory syndrome glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine histopathologically whether retinal pigment epithelial cells are present in the membrane tissues on the optic disc to investigate the mechanism causing retinal schisis/detachment associated with ODP-M and associated diseases.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The presence of retinal pigment epithelial cells in the membrane tissues on the optic disc
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) Patients over 20 years of the ages when agreements were taken. (2) Patients with retinal schisis associated with ODP-M or associated diseases who received the removal of the membrane tissues on the optic disc pit. (3) Patients that could get agreements by free will of patients themselves following enough understanding after having received enough explanation on participating of this study
Key exclusion criteria	(1) Patients with difficulty regarding making of these specimens because the membrane tissues removed by operation were too small. (2) In addition, patients whom principal investigator judged to be inappropriate as subjects
Target sample size	5

Research contact person
Name of lead principal investigator	Wataru Saito
Organization	Hokkaido University
Division name	opthalmology
Address	Nishi5-chome,Kita14-jou,Kitaku,Sapporoshi,Hokkaido
TEL	011-716-1161
Email	watasai716@gmail.com

Public contact
Name of contact person	Atsushi Tanaka
Organization	Hokkaido university
Division name	opthalmology
Address	Nishi5-chome,Kita14-jou,Kitaku,Sapporoshi,Hokkaido
TEL	08050804592
Homepage URL
Email	atanaka55@gmail.com

Sponsor
Institute	Hokkaido university opthalmology
Institute
Department

Funding Source
Organization	Hokkaido university opthalmology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 05 Day
Anticipated trial start date	2013 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Immunoreactivity for S100 protein and glial fibrillary acidic protein, markers of astrocytes, was positive in the resected membrane tissues
Other related information	Journal of Ophthalmology, vol. 2018, Article ID 5680503, 12 pages, 2018.

Management information
Registered date	2013 Year 07 Month 04 Day
Last modified on	2018 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013032