UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012070 |
|---|---|
| Receipt number | 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 21:02:33 |
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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
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
makoto.gozawa@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014108
