UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between anterior chamber protein concentration and surgical outcome in exfoliation glaucoma
Acronym	Anterior chamber protein concentration of exfoliation glaucoma
Scientific Title	Relationship between anterior chamber protein concentration and surgical outcome in exfoliation glaucoma
Scientific Title:Acronym	Anterior chamber protein concentration of exfoliation glaucoma
Region	Japan

Condition
Condition	glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Collect anterior chamber water during surgery. By measuring the protein concentration in the anterior chamber water, the relation between the incidence of desquamation glaucoma and the postoperative performance is evaluated.
Basic objectives2	Others
Basic objectives -Others	There is no report comparing desquamation concentrations in the eye of desquamation glaucoma with cases with only desquamation, the rate of transition to glaucoma is unknown. In addition, reports showing that trabeculectomy is effective for desquamation glaucoma in the past have been reported 2) 3), in recent years there have been cases in which intraocular pressure rises in the fifth year after surgery , It is inferred that the desquamation concentration may be involved in postoperative results. We focused on the concentration of desquamation in the anterior chamber as a factor related to the postoperative outcome of desquamating glaucoma. By collecting the anterior chamber water during surgery and measuring its concentration, the involvement of the incidence of desquamation glaucoma and the association of postoperative results are evaluated and the correlation with other findings is examined.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Protein concentration in the anterior chamber.IOP.
Key secondary outcomes	Visual acuity, endothelial cell density, pupil diameter

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cataract surgery group without any cataract disease
Interventions/Control_2	Cataract surgery group admitted desquamation but not having glaucoma
Interventions/Control_3	Glaucoma surgery group with desquamation glaucoma
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	A cataract operation group that does not recognize diseases other than cataract, a cataract operation group that admits desquamation but does not develop glaucoma, and a glaucoma operation group that has desquamation glaucoma, and explained the case before operation and consent was obtained
Key exclusion criteria	Patients who have disorders other than cataract and glaucoma. Patient who is difficult to collect anterior aqueous humor. Patient with poor fixation.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Shoji
Organization	Kitasato university
Division name	Ophthalmology
Zip code	2520329
Address	Kanagawa prefecture Sagamihara-shi Minami-ku Kitasato 1-15-1
TEL	0427788464
Email	kos@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Kono
Organization	Kitasato university
Division name	Ophthalmology
Zip code	2520329
Address	Kanagawa prefecture Sagamihara-shi Minami-ku Kitasato 1-15-1
TEL	0427788464
Homepage URL
Email	yusukeshonan@gmail.com

Sponsor
Institute	Kitasato university
Institute
Department

Funding Source
Organization	Kitasato university
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	Kitasato university
Address	Kanagawa prefecture Sagamihara-shi Minami-ku Kitasato 1-15-1
Tel	0427788464
Email	yusukeshonan@gmail.com

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	2019 Year 02 Month 01 Day

Related information
URL releasing protocol	https://www.kitasato-u.ac.jp/khp/
Publication of results	Unpublished

Result
URL related to results and publications	https://www.kitasato-u.ac.jp/khp/
Number of participants that the trial has enrolled	21
Results	The concentration of glycosaminoglycans in the water was below the detection limit of the test kit and could not be analyzed.
Results date posted	2021 Year 12 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Glaucoma patients who underwent glaucoma surgery
Participant flow	Recruit from surgical patients
Adverse events	No
Outcome measures	IOP, glycosaminoglycan in　aqueous humor
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 08 Month 01 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2020 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date	2018 Year 11 Month 30 Day
Last modified on	2021 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039993