UMIN-CTR Clinical Trial

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
Email	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
Email	s-uda@med.kanazawa-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kanazawa University Graduate School of Medical Science
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035938