UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020679 |
|---|---|
| Receipt number | R000023864 |
| Scientific Title | Changes in refractive power and posterior corneal shape following cataract surgery |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2024/07/29 17:46:07 |
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Basic information
Public title
Changes in refractive power and posterior corneal shape following cataract surgery
Acronym
posterior corneal shape following cataract surgery
Scientific Title
Changes in refractive power and posterior corneal shape following cataract surgery
Scientific Title:Acronym
posterior corneal shape following cataract surgery
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between refractive changes and posterior corneal power changes following cataract surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative data (visual acuity, refractive error, wavefront aberration, corneal topography, anterior chamber depth)
Key secondary outcomes
lens opacity, corneal endothelial cell density, operative data (ultrasound time, cumulative dissipated energy)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients receiving cataract surgery
Key exclusion criteria
Patients with corneal disease, high myopia, severe cataract and intraoperative complication
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Ueno |
Organization
University of Tsukuba
Division name
Majors in Medical Sciences
Zip code
3050035
Address
1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL
0298533148
yuueno@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Ueno |
Organization
University of Tsukuba
Division name
Majors in Medical Sciences
Zip code
3050035
Address
1-1-1 Tennoudai Tsukuba Ibaraki Japan
TEL
0298533148
Homepage URL
yu_ueno71@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kaiya eyes clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Amakubo Tsukuba Ibaraki Japan
Tel
0298533914
t-credo.adm@un.tsukuba.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
筑波大学付属病院（茨城県）、海谷眼科（愛知県）、かけ川海谷眼科（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective study
Subjects: Patients receiving cataract surgery from February 1, 2016 to November 30, 2017
Main outcome measures: Postoperative data (visual acuity, refractive error, wavefront aberration, corneal topography, anterior chamber depth)
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023864
