UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059658 |
|---|---|
| Receipt number | R000068243 |
| Scientific Title | Evaluation of Efficacy and Safety of a Novel Ultrasonic Phacoemulsification Unit |
| Date of disclosure of the study information | 2025/11/06 |
| Last modified on | 2025/11/06 09:27:42 |
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Basic information
Public title
Evaluation of Efficacy and Safety of a Novel Ultrasonic Phacoemulsification Unit
Acronym
Evaluation of a Novel Ultrasonic Phacoemulsification Unit
Scientific Title
Evaluation of Efficacy and Safety of a Novel Ultrasonic Phacoemulsification Unit
Scientific Title:Acronym
Evaluation of a Novel Ultrasonic Phacoemulsification Unit
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of an ultrasonic phacoemulsification unit newly released in 2025 with existing surgical devices.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient questionnaire on intraoperative pain and discomfort (VAS scale).
Key secondary outcomes
Surgery time, device parameters, postoperative visual acuity.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 UNITY
Interventions/Control_2
cataract surgery with Centurion
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 without ocular or systemic comorbidities who are candidates for routine cataract surgery.
Key exclusion criteria
Patients with comorbidities that affect the surgical procedure and postoperative outcomes, and those who cannot complete the postoperative questionnaire.
Target sample size
40
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, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
0298533148
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
305-0032
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
0298516927
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
Tel
0298533148
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
Ibaraki
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068243
