UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract.
Acronym	Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract.
Scientific Title	Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract.
Scientific Title:Acronym	Evaluation of the pre- and postoperative visual outcomes of phacoemulsification in patients with uveitis-associated cataract.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the pre- and postoperative outcomes of phacoemulsification, such as aqueous flares in the anterior chamber objectively as intraocular inflammation in patients with uveitis-associated cataract during remission, and compare to control subjects.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Intraocular inflammation measured by laser flare cell meter
Key secondary outcomes	Clinical findings

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	50 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	/The patients aged older than 50 years who were required cataract surgery with IOL implantation were included. Before surgery, quiescence of intraocular inflammation for more than 3 months with absence of systemic immunosuppressive therapy was a pre-requisite for eligibility for the surgery in patients with uveitis. /Patients without /Patients who had not undergone intraocular surgery.
Key exclusion criteria	/The patients with any previous ocular surgery in the eligible eye, preoperative trauma, pre-existing macular pathologies, vitreous hemorrhage, diabetes mellitus, rhegmatogenous retinal detachment, ocular surface disorders, glaucoma uncontrolled with medical treatment, and optic atrophy which were likely to affect surgical outcome, were excluded from the study. /Patients with systemic immunsuppressive therapy. /Patients who had undergone intraocular surgery. /Patients who were judged as no application by doctor.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Koh-Hei Middle name Last name Sonoda
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Ophthalmology
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5648
Email	sonodak@med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Atsunobu Middle name Last name Takeda
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Ophthalmology
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5648
Homepage URL
Email	atakeda@med.kyushu-u.ac.jp

Sponsor
Institute	Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	AMO Japan, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Graduate School of Medical Sciences, Kyushu University
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel	092-642-5648
Email	sonodak@med.kyushu-u.ac.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	九州大学病院、国立病院機構九州医療センター

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 17 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	67
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Preparing manuscript submission.
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	2016 Year 05 Month 30 Day
Date of IRB	2016 Year 06 Month 09 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 06 Month 30 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	N/A

Management information
Registered date	2020 Year 07 Month 17 Day
Last modified on	2020 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046987