UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054314 |
|---|---|
| Receipt number | R000062043 |
| Scientific Title | Comparison of postoperative visual function between TECNIS Odyssey and TECNIS Synergy |
| Date of disclosure of the study information | 2024/05/03 |
| Last modified on | 2025/06/01 08:17:14 |
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Basic information
Public title
Comparison of postoperative visual function between two multifocal IOLs
Acronym
Comparison of postoperative visual function between two multifocal IOLs
Scientific Title
Comparison of postoperative visual function between TECNIS Odyssey and TECNIS Synergy
Scientific Title:Acronym
Comparison of postoperative visual function between TECNIS Odyssey and TECNIS Synergy
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct multicenter study to compare visual function and patient satisfaction between a new multifocal IOL (TECNIS Odyssey) and a conventional multifocal IOL (TECNIS Synergy).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Uncorrected and distance-corrected visual acuity (5m, 70cm, 40cm, 30cm), degree of dysphotopsia, contrast sensitivity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
cataract surgery with TECNIS Odyssey
Interventions/Control_2
cataract surgery with TECNIS Synergy
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients operated on for age-related cataract
Key exclusion criteria
patients with irregular astigmatism, ocular and systemic diseases that influence visual acuity
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Oshika |
Organization
University of Tsukuba
Division name
Department of Ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3148
oshika@eye.ac
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Oshika |
Organization
University of Tsukuba
Division name
Department of Ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3148
Homepage URL
oshika@eye.ac
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fujita Eye Clinic, Mikawa Eye Clinic, Kanazawa Medical College, Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
Tel
029-853-3148
oshika@eye.ac
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2024 | 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
Management information
Registered date
| 2024 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062043
