UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027141 |
|---|---|
| Receipt number | R000031103 |
| Scientific Title | Factors affecting Eye Drop Instillation in Glaucoma Patients with visual field defect |
| Date of disclosure of the study information | 2017/04/26 |
| Last modified on | 2018/10/29 15:31:34 |
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Basic information
Public title
Factors affecting Eye Drop Instillation in Glaucoma Patients with visual field defect
Acronym
Factors affecting Eye Drop Instillation in Glaucoma Patients
Scientific Title
Factors affecting Eye Drop Instillation in Glaucoma Patients with visual field defect
Scientific Title:Acronym
Factors affecting Eye Drop Instillation in Glaucoma Patients
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the success rate of eye drop instillation in glaucoma patients with visual field defect(VFD) as well as non-glaucoma volunteers. Factors that may affecting the success rate of eye drop instillation was also evaluated.
Basic objectives2
Others
Basic objectives -Others
Success of eye drop instillation was judged by video pictures on the basis of the first one drop of solution applied on the cornea by two study investigators.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success of eye drop instillation was judged by video pictures on the basis of the first one drop of solution applied on the cornea by two study investigators.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Glaucoma patients or non-glaucoma volunteers
Key exclusion criteria
Subjects were excluded if they had a history of active ocular inflammation such as recurrent uveitis, scleritis, or corneal herpes as well as if they had ocular injuries, intraocular surgery, or laser surgery in advance of 3 months of the present study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Naito |
Organization
Okayama University Medical School Hospital
Division name
Ophthalmology
Zip code
Address
2-5-1 Shikata-cho, Okayama-shi, Okayama 700-8558, JAPAN
TEL
086-235-7297
tomokoum@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Naito |
Organization
Okayama University Medical School Hospital
Division name
Ophthalmology
Zip code
Address
2-5-1 Shikata-cho, Okayama-shi, Okayama 700-8558, JAPAN
TEL
086-235-7297
Homepage URL
tomokoum@gmail.com
Sponsor or person
Institute
Okayama University Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Medical School Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Open angle glaucoma patients with VFD as well as non-glaucoma volunteers were asked (requested) to video recording their procedure (maneuver) of eye drop instillation using a 5 mL plastic bottle of artificial tear solution. Success of eye drop instillation was judged by video pictures on the basis of the first one drop of solution applied on the cornea by two study investigators. A variety of factors relating to success rate of eye drop instillation such as VFD and clinical characteristics were also analyzed applying the multivariable logistic regression .
Management information
Registered date
| 2017 | Year | 04 | Month | 26 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031103
