UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059039 |
|---|---|
| Receipt number | R000067533 |
| Scientific Title | Prospective observational study evaluating the clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with macular hole |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/09 21:30:01 |
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Basic information
Public title
Prospective observational study evaluating the clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with macular hole
Acronym
Prospective observational study evaluating the clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with macular hole
Scientific Title
Prospective observational study evaluating the clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with macular hole
Scientific Title:Acronym
Prospective observational study evaluating the clinical performance of TECNIS Eyhance Optiblue in combined vitrectomy and cataract surgery in patients with macular hole
Region
| Japan |
Condition
Condition
cataract and macular hole
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 macular hole
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
distance unaided visual acuity, intermediate distance unaided visual acuity, surgery time, patient satisfaction with vision
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 macular hole.
Key exclusion criteria
The patients who have other diseases except for cataract and macular hole
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Hamamatsu university school of medicine
Division name
Department of ophthalmology
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
TEL
053-435-2256
h-kaneko@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Hamamatsu university school of medicine
Division name
Department of ophthalmology
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
TEL
053-435-2256
Homepage URL
h-kaneko@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
Hiroki Kaneko
Funding Source
Organization
Hamamatsu university 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
Hamamatsu University School of Medicine, Life Science and Medical Research Ethics Committee
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, 431-3192, Japan
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学医学部附属病院（静岡県）、関西医科大学附属病院（大阪府）、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）、医療法人社団同潤会眼科杉田病院（愛知県）、静岡赤十字病院（静岡県）、中東遠総合医療センター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2030 | Year | 08 | 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
| 2025 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067533
