UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005920 |
|---|---|
| Receipt number | R000006976 |
| Scientific Title | Change of choroidal thickness before and after cataract surgery using enhanced depth imaging spectral-domain optical coherence tomography. |
| Date of disclosure of the study information | 2011/07/05 |
| Last modified on | 2013/07/05 09:59:54 |
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Basic information
Public title
Change of choroidal thickness before and after cataract surgery using enhanced depth imaging spectral-domain optical coherence tomography.
Acronym
Change of choroidal thickness before and after cataract surgery using enhanced depth imaging spectral-domain optical coherence tomography.
Scientific Title
Change of choroidal thickness before and after cataract surgery using enhanced depth imaging spectral-domain optical coherence tomography.
Scientific Title:Acronym
Change of choroidal thickness before and after cataract surgery using enhanced depth imaging spectral-domain optical coherence tomography.
Region
| Japan |
Condition
Condition
Cataract surgery patients
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of cataract surgery on choroidal thickness.
Basic objectives2
Others
Basic objectives -Others
To study the choroidal anatomical changes associated with cataract surgery intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The choroidal thickness before cataract surgery is compared with that of 2 days, 1 week, 3 weeks, 14 weeks, and 24 weeks after surgery.
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
Cataract surgery patients with spherical equivalent refractive error between -3.0 and +3.0 diopters who are able to be measured spectral-domain optical coherence tomography.
Key exclusion criteria
The exclusion criteria are the presence of macular diseases, glaucoma, and the presence of severe cataract preventing detailed fundus observation in the study eye. Eyes are also excluded if they had history of ocular surgery.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideharu Ohsugi |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
Address
68-1, Waku, Aboshi-ku, Himeji, Hyogo Prefecture, Japan
TEL
079-272-8555
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideharu Ohsugi |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
Address
68-1, Waku, Aboshi-ku, Himeji, Hyogo Prefecture, Japan
TEL
079-272-8555
Homepage URL
h.ohsugi@tsukazaki-eye.net
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
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
| 2011 | Year | 07 | Month | 05 | 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 31 | Day |
Other
Other related information
To investigate the choroidal anatomical changes associated with cataract surgery intervention.
A prospective study of a consecutive sample of patients with cataract.
Management information
Registered date
| 2011 | Year | 07 | Month | 05 | Day |
Last modified on
| 2013 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006976
