UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060052 |
|---|---|
| Receipt number | R000068674 |
| Scientific Title | Comparison of surgical efficiency between UNITY VCS and CONSTELLATION |
| Date of disclosure of the study information | 2025/12/11 |
| Last modified on | 2025/12/11 13:10:33 |
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Basic information
Public title
Comparison of Surgical Efficiency in Cataract Surgery Device
Acronym
Comparison of Surgical Efficiency in Cataract Surgery Device
Scientific Title
Comparison of surgical efficiency between UNITY VCS and CONSTELLATION
Scientific Title:Acronym
Comparison of Surgical Efficiency in Cataract Surgery Device
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare and evaluate the surgical efficiency of cataract surgery using CONSTELLATION and UNITY VCS in patients with cataracts
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total U/S time
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 40 to 90 years diagnosed with cataract who underwent phacoemulsification and intraocular lens implantation, gender is not restricted.
2.Patients with nuclear hardness graded up to 2 to 3 according to the Emery Little classification.
3. Patients in whom a monofocal intraocular lens or a toric intraocular lens was implanted.
Key exclusion criteria
1. Patients who underwent other ocular surgeries within one month after cataract surgery, or with a history of ocular surgery including shallow anterior chamber, uveitis, progressive diabetic retinopathy, corneal degeneration, corneal transplantation, or corneal refractive surgery.
2. Patients with corneal endothelial cell density less than 1500 cells/mm2.
3.Patients in whom the IOL could not be completely fixed within the capsular bag during surgery.
4. Patients deemed inappropriate by the investigator due to systemic or ocular comorbidities.
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Sakanishi |
Organization
Sakanishi Eye Clinic
Division name
Department of Ophthalmology
Zip code
301-0004
Address
2976-1, Narimacho, Ryugasaki-shi, Ibaraki, Japan
TEL
0297-64-2355
ysakani@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Sakanishi |
Organization
Sakanishi Eye Clinic
Division name
Department of Ophthalmology
Zip code
301-0004
Address
2976-1, Narimacho, Ryugasaki-shi, Ibaraki, Japan
TEL
0297-64-2355
Homepage URL
ysakani@juntendo.ac.jp
Sponsor or person
Institute
Sakanishi Eye Clinic, Yoshihito Sakanishi
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MINS
Address
401, 20-9, Mita 5-chome, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2025 | Year | 12 | Month | 11 | 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
| 2025 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 11 | 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
Postoperative assessments will be conducted at 1 day and 1 week after cataract surgery. Observations include total ultrasound time, cumulative dissipated energy (CDE), time from phaco tip insertion to removal, and central corneal thickness. Best corrected visual acuity and refraction will also be measured. All data will be collected from routine clinical examinations and surgical records without imposing additional burden on patients.
Management information
Registered date
| 2025 | Year | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068674
