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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012070
Receipt No. R000014108
Scientific Title Observational study about the conjunctiva of the eyes sufferred from cataract surgery.
Date of disclosure of the study information 2013/10/18
Last modified on 2020/03/03

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Basic information
Public title Observational study about the conjunctiva of the eyes sufferred from cataract surgery.
Acronym Observational study about the conjunctiva of the eyes sufferred from cataract surgery.
Scientific Title Observational study about the conjunctiva of the eyes sufferred from cataract surgery.
Scientific Title:Acronym Observational study about the conjunctiva of the eyes sufferred from cataract surgery.
Region
Japan

Condition
Condition cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the bulbar conjunctiva sufferred from cataract surgery by means of anterior segment optical coherence tomography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We measure the thickness of bulbar conjunctival epithelium in the superior and temporal area at 1,2 and 3 mm posterior to the scleral spur.
We image with AS-OCT at 1 week, 1 month, 3 months, and 6 months after surgery to measure the thickness of the conjunctiva.
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 Patient whose age is 20 years old or more when agreement is acquired.

Patient who obtained agreement after enough explanation when participating in this study is recerved.

Patient with cataract.
Key exclusion criteria History of ocular surgery and inflamation.

Intraoperative complications such as posterior capsule rupture and severe iris damage.

Patient who is judged inappropriate for study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Gozawa
Organization University of Fukui, Faculty of medicine
Division name Ophthalmology
Zip code
Address 23-3 Shimoaiduki Matsuoka Yoshida Fukui
TEL 0776618403
Email makoto.gozawa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Gozawa
Organization University of Fukui, Faculty of medicine
Division name Ophthalmology
Zip code
Address 23-3 Shimoaiduki Matsuoka Yoshida Fukui
TEL 0776618403
Homepage URL
Email makoto.gozawa@gmail.com

Sponsor
Institute Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department

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
Email

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 10 Month 18 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
2013 Year 10 Month 01 Day
Date of IRB
2013 Year 10 Month 18 Day
Anticipated trial start date
2013 Year 10 Month 18 Day
Last follow-up date
2020 Year 03 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We measure the thickness of bulbar conjunctival epithelium in the superior and temporal area at 1,2 and 3 mm posterior to the scleral spur.
We image with AS-OCT at 1 week, 1 month, 3 months, and 6 months after surgery to measure the thickness of the conjunctiva.

Management information
Registered date
2013 Year 10 Month 18 Day
Last modified on
2020 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014108

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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