UMIN-CTR Clinical Trial

Basic information
Public title	Observatinal study to evaluate the correlation between Meibomian gland dysfunction, dry eye syndrome and diabetes
Acronym	Observatinal study to evaluate the correlation between Meibomian gland dysfunction, dry eye syndrome and diabetes
Scientific Title	Observatinal study to evaluate the correlation between Meibomian gland dysfunction, dry eye syndrome and diabetes
Scientific Title:Acronym	Observatinal study to evaluate the correlation between Meibomian gland dysfunction, dry eye syndrome and diabetes
Region	Japan

Condition
Condition	Meibomian gland dysfunction
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the prevalence and related factors of Meibomian gland dysfunction and dry eye syndrome in patients with diabetes
Basic objectives2	Others
Basic objectives -Others	To examine the effect of diabetes on ocular surface and Meibomian gland function
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Meibomian gland dysfunction dry eye syndrome
Key secondary outcomes	SPEED and J-OSDI questionnaire tear meniscus height tear breakup time corneal fluorescein staining lid abnormalities around Meibomian orifice expression of meibum Meibomian gland loss

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	35 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Subject with and not with diabetes
Key exclusion criteria	1.previous ocular surgery except for laser photocoagulation and intravitreal or subtenon injection 2.active ocular infection or inflammation 3. continuous use of topical ocular medications 4. daily contact lens wearing over a month in the last five years 5. a history of cranial nerve injury 6. ocular or systemic diseases known to affect the tear film 7. use of systemic drugs known to affect the tear film
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Miho Middle name Last name Shimizu
Organization	Sapporo City General Hospital
Division name	Department of ophthalmology
Zip code	060-8604
Address	1-1, North 11, West 13, Sapporo, 060-8604, Japan
TEL	+81-11-726-2211
Email	miho4518@yahoo.co.jp

Public contact
Name of contact person	1st name Miho Middle name Last name Shimizu
Organization	Sapporo City General Hospital
Division name	Department of ophthalmology
Zip code	060-8604
Address	1-1, North 11, West 13, Sapporo, 060-8604, Japan
TEL	+81-11-726-2211
Homepage URL
Email	miho4518@yahoo.co.jp

Sponsor
Institute	Sapporo City General Hospital
Institute
Department

Funding Source
Organization	Sapporo City General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sapporo City General Hospital
Address	1-1, North 11, West 13, Sapporo, 060-8604, Japan
Tel	+81-11-726-2211
Email	ho.syomu@city.sapporo.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	市立札幌病院

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 26 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	2021 Year 01 Month 04 Day
Date of IRB	2021 Year 01 Month 14 Day
Anticipated trial start date	2021 Year 01 Month 27 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study type -Observational Measurement item SPEED and J-OSDI questionnaire tear meniscus height tear breakup time corneal fluorescein staining lid abnormalities around Meibomian orifice expression of meibum Meibomian gland loss

Management information
Registered date	2021 Year 01 Month 25 Day
Last modified on	2022 Year 07 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049206