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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028385
Receipt No. R000032490
Scientific Title Surgically induced changes in astigmatism and shape of total and posterior cornea after nasal versus temporal clear corneal incision (CCI) cataract surgery: a prospective randomized clinical study.
Date of disclosure of the study information 2017/07/26
Last modified on 2018/06/22

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Basic information
Public title Surgically induced changes in astigmatism and shape of total and posterior cornea after nasal versus temporal clear corneal incision (CCI) cataract surgery: a prospective randomized clinical study.
Acronym Corneal shape changes of total and posterior corneas after nasal versus temporal clear corneal incisions.
Scientific Title Surgically induced changes in astigmatism and shape of total and posterior cornea after nasal versus temporal clear corneal incision (CCI) cataract surgery: a prospective randomized clinical study.
Scientific Title:Acronym Corneal shape changes of total and posterior corneas after nasal versus temporal clear corneal incisions.
Region
Japan

Condition
Condition Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare surgically induced astigmatism (SIA) and shape changes of total and posterior cornea between eyes that underwent nasal clear corneal incisions (CCI) and eyes that underwent temporal CCI in cataract surgery.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Patients are to undergo examinations at 2 days and at 2, 4, and 8 weeks after surgery.
1) Corneal astigmatism of anterior and posterior corneas (simulated K value of a videokeratography system; Tomey TMS-5)
2) Corneal shape changes of anterior and posterior cornea (average of difference map of TMS-5)
Key secondary outcomes 3) Irregular astigmatism components (asymmetry and higher-order irregularity components)
4) Ocular higher order aberrations (HOAs)
5) Visual acuity and refractive status
6) Wound length and width
7) Pupil diameter
8) Surgical factors

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 One hundred left eyes of 100 patients with with-the-rule astigmatism of 0.5 D or less were randomly assigned to one of the two groups.
Interventions/Control_2 50 eyes were to undergo nasal CCI and 50 eyes were to undergo temporal CCI.
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 One hundred left eyes of 100 patients with with-the-rule astigmatism of 0.5 D or less.
Key exclusion criteria Exclusion criteria were 1) eyes with any pathology of cornea, optic nerve, and macula; 2) eyes with lens nucleus harder than grade 4 according to the Lens Opacities Classification System III; 3) eyes with a poor mydriasis less than 4.5 mm; 4) eyes with possible zonular weakness, 5) eyes with pseudoexfoliation; 6) eyes with prior history of ocular surgery and inflammation, 7) patients with diabetes; 8) patients who were referred from other hospitals, and 9) patients who had been enrolled in other studies
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Hayashi
Organization Hayashi Eye Hospital
Division name Department of ophthalmology
Zip code
Address 4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
TEL 092-431-1680
Email hayashi-ken@hayashi.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Hayashi
Organization Hayashi Eye Hospital
Division name Department of ophthalmology
Zip code
Address 4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
TEL 092-431-1680
Homepage URL
Email hayashi-ken@hayashi.or.jp

Sponsor
Institute Hayashi Eye Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 林眼科病院(福岡県)/ Hayashi Eye Hospital(Fukuoka)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 26 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
2016 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 26 Day
Last modified on
2018 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032490

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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