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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013470
Receipt No. R000015725
Scientific Title Interface Fluid Syndrome after LASIK in a Patient with Glaucoma Induced by Uncontrolled Intraocular Pressure without Triggering Factors
Date of disclosure of the study information 2014/03/20
Last modified on 2016/03/20

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Basic information
Public title Interface Fluid Syndrome after LASIK in a Patient with Glaucoma Induced
by Uncontrolled Intraocular Pressure without Triggering Factors
Acronym Interface Fluid Syndrome after LASIK in a Patient with Glaucoma Induced
by Uncontrolled Intraocular Pressure without Triggering Factors
Scientific Title Interface Fluid Syndrome after LASIK in a Patient with Glaucoma Induced
by Uncontrolled Intraocular Pressure without Triggering Factors
Scientific Title:Acronym Interface Fluid Syndrome after LASIK in a Patient with Glaucoma Induced
by Uncontrolled Intraocular Pressure without Triggering Factors
Region
Japan

Condition
Condition Interface Fluid Syndrome after LASIK in a Patient with Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe a patient with glaucoma with interface fluid syndrome (IFS) after laser in situ keratomileusis (LASIK) induced by uncontrolled intraocular pressure (IOP) without triggering factors
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ・Age
・Gender
・Visual Acuity(Refraction):Distant Visual Acuity
・Intraocular Pressure measured by Goldmann applanation tonometer
・General ophthalmologic examination: Slit-lamp microscopy, Gonioscopic examination and Ophthalmoscopy
・Visual field: Humphrey Field Analyzer or Goldmann perimeter
・Cell density of Corneal endothelium
.Anti-glaucomatous medications and performed surgery(Trabeculectomy)

Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Interface Fluid Syndrome without Triggering Factors
Key exclusion criteria None of the above
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Shoji
Organization Kitasato University, School of Allied Health Science
Division name Department of Rehabilitation, Orthoptics and Visual Science
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa Japan
TEL 042-778-9679
Email nshoji@ahs.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Shoji
Organization Kitasato University Hospital
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa Japan
TEL 042-778-9679
Homepage URL
Email nshoji@ahs.kitasato-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Kitasato University Hospital
Institute
Department

Funding Source
Organization None
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
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 北里大学病院(神奈川県) Kitasato University Hospital(Kanagawa)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 20 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Interface Fluid Syndrome after LASIK in a Patient with Glaucoma

Management information
Registered date
2014 Year 03 Month 20 Day
Last modified on
2016 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015725

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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