UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050233 |
|---|---|
| Receipt number | R000057211 |
| Scientific Title | Evaluation of changes in diurnal variation of intraocular pressure with glaucoma treatment using the Triggerfish. |
| Date of disclosure of the study information | 2023/02/04 |
| Last modified on | 2023/02/03 23:52:05 |
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Basic information
Public title
Evaluation of changes in diurnal variation of intraocular pressure with glaucoma treatment using the Triggerfish.
Acronym
Evaluation of changes in diurnal variation of intraocular pressure with glaucoma treatment using the Triggerfish.
Scientific Title
Evaluation of changes in diurnal variation of intraocular pressure with glaucoma treatment using the Triggerfish.
Scientific Title:Acronym
Evaluation of changes in diurnal variation of intraocular pressure with glaucoma treatment using the Triggerfish.
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, We investigated which glaucoma treatments can control diurnal variation of intraocular pressure using triggerfish.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the absolute difference between the highest and lowest contactlens sensor values (mVeq), as measured by the triggerfish before and 1-3 month after the addition of glaucoma treatment.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measure diurnal variation of intraocular pressure before and 1-3 months after the addition of glaucoma treatment for patients determined to require additional glaucoma treatment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Males and females over 20 years of age at the time of registration
2) Patients with glaucoma, preperimetric glaucoma, ocular hypertension, and angle-closure glaucoma who require additional glaucoma treatment
3) Patients who have received sufficient explanation about participation in this research and have obtained written consent of their own free will
Key exclusion criteria
1) Patients who cannot wear contact lenses (patients with contraindicated target diseases as listed in the Triggerfish package insert)
2) Patients who have a history of intraocular surgery within the past 3 months in the test eye
3) Patients who have a history of refractive surgery in the past
4) Patients with a history of glaucoma surgery in the past
5) Patients with keratoconus or other corneal diseases
6) Patients with conjunctivitis or endophthalmitis
7) Other patients who are deemed unsuitable for inclusion in the subject by the physician's judgment
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokai University School of Medicine
Division name
Department of Ophthalmology
Zip code
259-1193
Address
143 Shimokasuya, Isehara City, Kanagawa Prefecture Japan
TEL
0463-93-1121
nakayosi@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokai University School of Medicine
Division name
Department of Ophthalmology
Zip code
259-1193
Address
143 Shimokasuya, Isehara City, Kanagawa Prefecture Japan
TEL
0463-93-1121
Homepage URL
313550@cc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board for Clinical Research, Tokai Universit
Address
143 Shimokasuya, Isehara City, Kanagawa Prefecture Japan
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
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
| 2023 | Year | 02 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057211
