UMIN-CTR Clinical Trial

Basic information
Public title	Effects of eyelid pressure on outcome of filtration surgery
Acronym	Effects of eyelid pressure on outcome of filtration surgery
Scientific Title	Effects of eyelid pressure on outcome of filtration surgery
Scientific Title:Acronym	Effects of eyelid pressure on outcome of filtration surgery
Region	Japan

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

Objectives
Narrative objectives1	To determine the effect of the deepening of the upper eyelid sulcus (DUES) and the eyelid pressure on the outcome of filtration surgery in glaucomatous eyes refractory to prostaglandin analogs.
Basic objectives2	Others
Basic objectives -Others	To determine the effect of the eyelid pressure on the outcome of filtration surgery.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The eyelid pressure and the DUES were measured before the surgery and were compared to that at 24 months after the surgery.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with glaucoma who were being treated by prostaglandin analogs and had undergone trabeculectomy or Ex-PRESS shunt. The surgeries were performed by the same surgeon at the Ehime University Hospital between August 2015 and April 2016.
Key exclusion criteria	Subjects were excluded if they had a history of active ocular inflammation such as recurrent uveitis, scleritis, or corneal herpes as well as if they had ocular injuries, intraocular surgery, or laser surgery in advance of 3 months of the present study.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Namiguchi
Organization	Ehime University Graduate School of Medicine
Division name	Ophthalmology
Zip code	791-0295
Address	Shitsukawa, Toon-shi, Ehime 791-0295, JAPAN
TEL	0899605361
Email	k.nami1027@gmail.com

Public contact
Name of contact person	1st name Koji Middle name Last name Namiguchi
Organization	Ehime University Graduate School of Medicine
Division name	Ophthalmology
Zip code	791-0295
Address	Shitsukawa, Toon-shi, Ehime 791-0295, JAPAN
TEL	0899605361
Homepage URL
Email	k.nami1027@gmail.com

Sponsor
Institute	Department of Ophthalmology Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology Ehime University Graduate School of Medicine,
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	Department of Ophthalmology Ehime University Graduate School of Medicine,
Address	Shitsukawa, Toon-shi, Ehime 791-0295, JAPAN
Tel	0899605361
Email	k.nami1027@gmail.com

Secondary IDs
Secondary IDs	YES
Study ID_1	1509008
Org. issuing International ID_1	Ehime University Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	愛媛大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 08 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	19
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	Completed
Date of protocol fixation	2015 Year 08 Month 01 Day
Date of IRB	2017 Year 07 Month 24 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2020 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To determine the effect of the deepening of the upper eyelid sulcus (DUES) and the eyelid pressure on the outcome of filtration surgery in glaucomatous eyes refractory to prostaglandin analogs.

Management information
Registered date	2020 Year 11 Month 08 Day
Last modified on	2020 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048380