UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025345 |
|---|---|
| Receipt number | 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 12:15:43 |
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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
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
hayashi-ken@hayashi.or.jp
Sponsor or person
Institute
Hayashi Eye Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029150
