UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051049 |
|---|---|
| Receipt number | R000058207 |
| Scientific Title | A prospective observational study to explore the effect of adherence to CPAP therapy on the progression of glaucoma |
| Date of disclosure of the study information | 2023/05/12 |
| Last modified on | 2023/05/12 17:57:30 |
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Basic information
Public title
A prospective observational study to explore the effect of adherence to continuous positive airway pressure (CPAP) therapy on the progression of glaucoma
Acronym
A prospective observational study to explore the effect of adherence to CPAP therapy on the progression of glaucoma
Scientific Title
A prospective observational study to explore the effect of adherence to CPAP therapy on the progression of glaucoma
Scientific Title:Acronym
A prospective observational study to explore the effect of adherence to CPAP therapy on the progression of glaucoma
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the effect of adherence to CPAP therapy on inhibition of glaucoma progression in patients diagnosed with sleep apnea syndrome (SAS) as the primary outcome of this study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of change of glaucoma progression associated with CPAP therapy (Mean Deviation slope (MD slope) using Humphrey Field Analyzer (HFA) 24-2)
Key secondary outcomes
1. Severity of sleep SAS at diagnosis
2. Apnea Hypopnea Index (AHI) before CPAP therapy
3. AHI during CPAP therapy
4. Number of hours CPAP therapy used /Number of days CPAP therapy used
5. Biomarkers of oxidative stress (e.g. diacron reactive oxygen metabolites (d-ROMs) and biological antioxidant potential (BAP))
6. Ophthalmological examination (Refraction, corneal curvature radius, axial length, corneal thickness, corneal elasticity, visual acuity, intraocular pressure, ophthalmoscopy, three-dimensional image analysis of ocular fundus, visual field test, optical coherence tomography angiography, laser speckle flowgraphy)
7. Vital signs (Blood pressure, pulse rate, peripheral oxygen saturation (SpO2))
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with normal tension glaucoma (Intraocular pressure of 16 mmHg or below)
2. Individuals who are suspected to be affected by progressive visual field defect as indicated in Humphrey visual field test despite pharmaceutical treatment
3. Individuals who are diagnosed with SAS as a result of scoring 20 or more in AHI and are considered patients that need CPAP therapy
4. Glaucoma patients of all disease stages
Key exclusion criteria
1. Outpatients periodically attending ophthalmology check-up due to severe eye condition
2. Individuals who plan to undergo surgery for glaucoma during observation period
3. Individuals with high myopia (Axial length of 26.5 mm or above and spherical equivalent of -8D or above)
4. Individuals who have undergone LASIK
5. Individuals who have undergone ophthalmologic surgery in the last three months
6. Individuals suffering from cancer
7. Individuals suffering from hormonal disorder (e.g. autoimmune disease, hyperthyroidism)
8. Individuals who are taking oral contraceptive pill
9. Individuals who are pregnant, or planning pregnancy or breastfeeding during study period
10. Individuals who are deemed ineligible for participation by the principal investigator or co-investigator due to other reasons
11. Individuals who are currently receiving CPAP therapy
12. Individuals who did not give informed consent or decline disclosure of research information
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Himori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7294
Homepage URL
n-himori@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
TEIJIN PHARMA LIMITED.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seiryo Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
星陵眼科 緑内障クリニック (宮城県)
Seiryo Eye Clinic (Miyagi, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: A prospective longitudinal study
Objective: To prospectively evaluate the effect of adherence to CPAP therapy on inhibition of glaucoma progression in patients diagnosed with SAS as the primary outcome of this study
Recruitment method: Outpatients attending Seiryo Eye Clinic who have given informed consent will be enrolled
Recruitment period (scheduled): Until April, 2024
Evaluation items: The rate of change of glaucoma progression associated with CPAP therapy, the severity of SAS at diagnosis, AHI before CPAP therapy, AHI during CPAP therapy, number of hours CPAP therapy used/number of days CPAP therapy used, biomarkers of oxidative stress, ophthalmological examination, and vital signs
Results: Unpublished
Management information
Registered date
| 2023 | Year | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058207
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