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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043349
Receipt No. 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 2021/02/17

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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
Email 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
Email kamiyak-tky@umin.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 52
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 No longer recruiting
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
2021 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049494

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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