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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025345
Receipt No. R000029150
Scientific Title Surgically Induced Astigmatic Change and Shape Changes of Total, Anterior, and Posterior Corneas After Long- versus Short-Length Clear Corneal Incision Cataract Surgery: A Randomized Clinical Study
Date of disclosure of the study information 2016/12/21
Last modified on 2017/06/21

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Basic information
Public title Surgically Induced Astigmatic Change and Shape Changes of Total, Anterior, and Posterior Corneas After Long- versus Short-Length Clear Corneal Incision Cataract Surgery: A Randomized Clinical Study
Acronym Surgically Induced Astigmatism and Shape Changes of Total, Anterior, and Posterior Corneas After Long versus Short Clear Corneal Incision Cataract Surgery
Scientific Title Surgically Induced Astigmatic Change and Shape Changes of Total, Anterior, and Posterior Corneas After Long- versus Short-Length Clear Corneal Incision Cataract Surgery: A Randomized Clinical Study
Scientific Title:Acronym Surgically Induced Astigmatism and Shape Changes of Total, Anterior, and Posterior Corneas After Long versus Short Clear Corneal Incision Cataract Surgery
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, anterior, or posterior cornea between eyes with long-length clear corneal incisions (CCIs) and eyes with short-length CCIs in cataract surgery.
Basic objectives2 Others
Basic objectives -Others Eyes are to randomly assigned to undergo long-length (not less than 1.75 mm) or short-length (<1.75mm) CCI of 2.4 mm in width SIA of total, anterior, and posterior corneas is determined using power vector analysis, and corneal shape changes are assessed using a videokeratography preoperatively, and postoperatively at 2 days, and 2, 4, and 8 weeks.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
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 total, anterior, and posterior corneas (simulated K value of a videokeratography system; Tomey TMS-5)
2) Surgically induced astigmatic change of total, anterior, and posterior corneas (power vector analysis)
3) Shape changes in of total, anterior, and posterior corneas (average of difference map of TMS-5)
Key secondary outcomes 4) Incision length of clear corneal incisions
5) Irregular astigmatism components (asymmetry and higher-order irregularity components)
6) Ocular, corneal, and internal optic higher order aberrations (HOAs)
7) Corrected distance visual acuity and manifest spherical equivalent value

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 Bilateral (240) eyes of 120 patients are randomly assigned to undergo long-length (no more than 1.75mm)
Interventions/Control_2 That reverse eyes 120 patients are randomly assigned to undergo short-length (<1.75mm) clear corneal incision (CCI)of 2.4 mm in width.
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 Patients who are scheduled for bilateral phacoemulsification surgery with an acrylic intraocular lens (IOL) implantation at the Hayashi Eye Hospital between November 1, 2015 and November 11, 2016.
Key exclusion criteria Exclusion criteria are eyes with pathologies except for cataract; eyes with pseudoexfoliation syndrome; eyes that were to undergo planned extracapsular or intracapsular cataract extraction; eyes with a possible zonular dehiscence; a history of ocular surgery or inflammation; patients with diabetes mellitus; patients who refused the inclusion in the study; and difficulties with examination or follow-up. Patients who were enrolled in other studies were excluded.
Target sample size 120

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
2016 Year 12 Month 21 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 10 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 30 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
2016 Year 12 Month 21 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029150

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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