UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030513 |
|---|---|
| Receipt number | 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 12:09:45 |
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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
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
None
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034834
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