UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031483 |
|---|---|
| Receipt number | R000035938 |
| Scientific Title | Preperimetric glaucoma (PPG) evaluation by OCT oriented perimetry with adjusting for retinal ganglion cell (RGC) displacement |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/01/03 14:58:36 |
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Basic information
Public title
Preperimetric glaucoma (PPG) evaluation by OCT oriented perimetry with adjusting for retinal ganglion cell (RGC) displacement
Acronym
Preperimetric glaucoma (PPG) evaluation by OCT oriented perimetry with adjusting for retinal ganglion cell (RGC) displacement
Scientific Title
Preperimetric glaucoma (PPG) evaluation by OCT oriented perimetry with adjusting for retinal ganglion cell (RGC) displacement
Scientific Title:Acronym
Preperimetric glaucoma (PPG) evaluation by OCT oriented perimetry with adjusting for retinal ganglion cell (RGC) displacement
Region
| Japan |
Condition
Condition
Glaucoma
Normal
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the performance of an OCT oriented perimetry with adjusting for RGC displacement in PPG.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the best parameter of an OCT oriented perimetry with adjusting for RGC displacement for PPG detection.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
PPG eye
1.Abnormal glaucomatous appearance of the optic disc on simultaneous stereo photographs.
2.No other intraocular eye disease
3.No visual field defects on standard automated perimetry corresponding to glaucomatous appearance of the optic disc.
4.Axial length within 26.5mm
5.Corrected visual acuity more 0.9
6.Subjects who agree to the participation in this study.
Normal eye
1.Normal optic disc on simultaneous stereo photographs.
2.No any intraocular eye disease
3.IOP within 20 mmHg
4.Axial length within 26.5mm
5.Corrected visual acuity more 0.9
6.Subjects who agree to the participation in this study.
Key exclusion criteria
PPG
1.History of disease which affect the visual field sensitivity except glaucoma.
2.History of intraocular surgery.
3.History of medications which affect visual field sensitivity.
4.IOL inserted eye
Normal eye
1.History of disease which affect the visual field sensitivity.
2.History of intraocular surgery.
3.History of medications which affect visual field sensitivity.
4.IOL inserted eye
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Sugiyama |
Organization
Department of Ophthalmology and Visual Science, Kanazawa University Graduate School of Medical Science
Division name
Ophthalmology
Zip code
Address
13-1 Takara-machi, Kanazawa , Ishikawa ,Japan
TEL
076-265-2403
ksugi@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Udagawa |
Organization
Kanazawa University Hospital
Division name
Ophthalmology
Zip code
Address
13-1 Takara-machi, Kanazawa , Ishikawa ,Japan
TEL
076-265-2403
Homepage URL
s-uda@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ohkubo Eye Clinic,Tajimi Iwase Eye Clinic
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
金沢大学附属病院（石川県）
おおくぼ眼科クリニック（石川県）
たじみ岩瀬眼科（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
| 2017 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preperimetric glaucoma
Perimetry
OCT
Structure and function
RGC displacement
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035938
