UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018772 |
|---|---|
| Receipt number | R000021386 |
| Scientific Title | Effect of topical corneal anaesthesia on intra-ocular pressure corrected with corneal hysteresis |
| Date of disclosure of the study information | 2015/08/23 |
| Last modified on | 2016/02/23 09:39:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of topical corneal anaesthesia on intra-ocular pressure corrected with corneal hysteresis
Acronym
Effect of topical corneal anaesthesia on corneal hysteresis
Scientific Title
Effect of topical corneal anaesthesia on intra-ocular pressure corrected with corneal hysteresis
Scientific Title:Acronym
Effect of topical corneal anaesthesia on corneal hysteresis
Region
| Japan |
Condition
Condition
normal subjects
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of corneal topical anesthesia on intra-ocular pressure corrected with corneal hysteresis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra-ocular pressure corrected with corneal hysteresis before and after instillation of corneal topical anesthesia.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Instillation of hydrochloric acid oxybuprocaine (Benoxil 0.4%).
Instillation of lidocaine hydrochloride (Xylocaine 4%).
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No history of intra-ocular surgery and refractive surgery.
Corneal astigmatism is less than -2 diopter.
Best corrected visual acuity is more than 1.0.
Key exclusion criteria
The patient who had ocular disease.
Corneal astigmatism is more than -2 diopter.
Best corrected visual acuity is less than 1.0.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shoji |
Organization
School of Allied Health Sciences, Kitasato University
Division name
Orthoptics and Visual Science
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
042-778-9671
nshoji@ahs.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Hirasawa |
Organization
School of Allied Health Sciences, Kitasato University
Division name
Orthoptics and Visual Science
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
042-778-9671
Homepage URL
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
School of Allied Health Sciences, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
School of Allied Health Sciences, Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 23 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 23 | Day |
Last modified on
| 2016 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021386
