UMIN-CTR Clinical Trial

Basic information
Public title	Clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with ERM
Acronym	Clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with ERM
Scientific Title	Clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with ERM
Scientific Title:Acronym	Clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with ERM
Region	Japan

Condition
Condition	cataract and epiretinal membrane
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with ERM
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	distance visual acuity, intermediate visual acuity
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	The patients who receive combined vitrectomy and cataract surgery in patients with ERM.
Key exclusion criteria	The patients who have other diseases except for cataract and ERM
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Kaneko
Organization	Nagoya University
Division name	Department of Ophthalmology
Zip code	466-8550
Address	65 Tsurumai, Showa-ku, Nagoya
TEL	0527442275
Email	h-kaneko@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Kaneko
Organization	Nagoya University
Division name	Department of Ophthalmology
Zip code	466-8550
Address	65 Tsurumai, Showa-ku, Nagoya
TEL	052-744-2277
Homepage URL
Email	h-kaneko@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Nagoya University
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Nagoya University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Department of Ophthalmology, Nagoya University
Address	65 Tsurumai-cho, Showa-ku, Nagoya
Tel	052-744-2277
Email	h-kaneko@med.nagoya-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	名古屋大学医学部附属病院（愛知県）、医療法人湘山会眼科三宅病院（愛知県）、西尾市民病院（愛知県）、医療法人豊田会刈谷豊田総合病院（愛知県）、一宮市立市民病院（愛知県）

Other administrative information
Date of disclosure of the study information	2022 Year 05 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	Open public recruiting
Date of protocol fixation	2022 Year 03 Month 11 Day
Date of IRB	2022 Year 06 Month 14 Day
Anticipated trial start date	2022 Year 05 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2022 Year 03 Month 17 Day
Last modified on	2022 Year 06 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053842