UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043349 |
|---|---|
| Receipt number | R000049494 |
| Scientific Title | Comparison of mean absolute surgically induced astigmatism and centroid value after cataract surgery. |
| Date of disclosure of the study information | 2021/02/17 |
| Last modified on | 2022/08/21 19:09:58 |
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Basic information
Public title
Comparison of mean absolute surgically induced astigmatism and centroid value after cataract surgery.
Acronym
Comparison of surgically induced astigmatism after cataract surgery.
Scientific Title
Comparison of mean absolute surgically induced astigmatism and centroid value after cataract surgery.
Scientific Title:Acronym
Comparison of surgically induced astigmatism after cataract surgery.
Region
| Japan |
Condition
Condition
Patients undergoing cataract surgery.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the mean-SIA and the centnoid-SIA after standard cataract surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgically induced astigmatism (SIA)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
eyes undergoing requiring bilateral cataract surgery using a 2.8-mm temporal corneal incision by one experienced surgeon
Key exclusion criteria
concomitant corneal diseases, including irregular corneal astigmatism, keratoconus, or severe dry eye, the onset of intraoperative or postoperative complications, eyes requiring a wound enlargement, or eyes requiring sutures.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
Homepage URL
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel
0427788464
kamiyak-tky@umin.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 17 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34150805/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34150805/
Number of participants that the trial has enrolled
100
Results
standard cataract surgery induces the M-SIA by approximately 0.5 D. The magnitude of the C-SIA largely decreased to approximately 40% of the M-SIA, and the direction of the C-SIA showed a tendency toward with-the-rule astigmatism.
Results date posted
| 2022 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
cataract surgery through a 2.8 mm temporal clear corneal incision
Participant flow
retrospective review of the clinical charts
Adverse events
No significant complications
Outcome measures
the arithmetic mean of surgically induced astigmatism (M-SIA) and the centroid of surgically induced astigmatism (C-SIA)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We quantitatively investigate the amount of corneal astigmatism before and 3 months after surgery using an automated keratometer (TONOREFF-II, Nidek). The surgically induced astigmatism is assessed by vector analysis using the Holladay-Cravy-Koch formula.
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2022 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049494
| Research Plan | |
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| Registered date | File name |
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