UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047202 |
|---|---|
| Receipt number | R000053842 |
| Scientific Title | Clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with ERM |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/06/29 21:01:49 |
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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
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
h-kaneko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Nagoya University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053842
