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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030513
Receipt No. R000034834
Scientific Title Randomized double-masked comparative study of intraocular pressure (IOP) and wound architectures immediately after cataract surgery between eyes with long-length clear corneal incision (CCI) and short-lengh clear corneal incision.
Date of disclosure of the study information 2017/12/22
Last modified on 2018/06/22

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Basic information
Public title Randomized double-masked comparative study of intraocular pressure (IOP) and wound architectures immediately after cataract surgery between eyes with long-length clear corneal incision (CCI) and short-lengh clear corneal incision.
Acronym Intraocular pressure (IOP) and wound architectures in eyes immediately after long and short clear corneal incision cataract surgery
Scientific Title Randomized double-masked comparative study of intraocular pressure (IOP) and wound architectures immediately after cataract surgery between eyes with long-length clear corneal incision (CCI) and short-lengh clear corneal incision.
Scientific Title:Acronym Intraocular pressure (IOP) and wound architectures in eyes immediately after long and 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 the present study was to compare the IOP and wound architectures immediately after phacoemulsificaton surgery between eyes that underwent long-length CCI (more than 1.75mm) and eyes that underwent short-length CCI (less than 1.75 mm.)
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Longitudinal changes in intraocular pressure (IOP) using rebound tonometer before surgery, at the end of surgery (adjusted in a range between 15 and 25 mmHg); and at 30, 60, 120, 180 minutes, and 24 hours after surgery
2) Wound architectural features and wound length at 60 minutes after surgery using the anterior segment-optical coherence tomography (AS-OCT)
Key secondary outcomes 3) Wound leakage at 60 minutes after surgery examined using the Seidel test
4) Flare intensity at 60 minutes after surgery determined using the flare meter

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
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 64 eyes of 64 patients are scheduled to undergo long-length temporal CCI (more than 1.75 mm).
Interventions/Control_2 64 eyes of 64 patients are scheduled to undergo short-length temporal CCI (less than 1.75 mm).
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 This study was an exploratory study to compare the IOP and wound architectures between eyes with long CCI and eyes with short CCI, conducted between January and December, 2017 at the Hayashi Eye Hospital. A clinical research coordinator screened all consecutive patients scheduled for admitting the Hayashi Eye Hospital to undergo bilateral phacoemulsification and implantation of a single-piece acrylic intraocular lens (IOL).
Key exclusion criteria eyes with any pathology of the cornea, macula, and optic nerve; eyes with lens nucleus harder than grade 4 according to the Lens Opacities Classification System III;14 eyes with a possible zonular dehiscence, a history of ocular inflammation or surgery; eyes with poor mydriasis smaller than 4.5 mm; patient refusal; and any anticipated difficulties with examination
Target sample size 128

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 None
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(福岡市)Hayashi Eye Hospital(Fukuoka)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 22 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
Not analyzed
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
2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 04 Day
Last follow-up date
2017 Year 12 Month 19 Day
Date of closure to data entry
2017 Year 12 Month 19 Day
Date trial data considered complete
2017 Year 12 Month 19 Day
Date analysis concluded
2017 Year 12 Month 29 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 22 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=R000034834

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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