UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059646 |
|---|---|
| Receipt number | R000068227 |
| Scientific Title | The usefulness of the UNITY VCS Tetra-Spot Laser Probe in panretinal photocoagulation (PRP) |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 15:32:18 |
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Basic information
Public title
The usefulness of the UNITY VCS Tetra-Spot Laser Probe in panretinal photocoagulation (PRP)
Acronym
The usefulness of the UNITY VCS Tetra Spot Laser Probe
Scientific Title
The usefulness of the UNITY VCS Tetra-Spot Laser Probe in panretinal photocoagulation (PRP)
Scientific Title:Acronym
The usefulness of the UNITY VCS Tetra Spot Laser Probe
Region
| Japan |
Condition
Condition
Patients with proliferative diabetic retinopathy requiring panretinal photocoagulation (PRP) treatment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and evaluate the surgical efficiency and postoperative outcomes of vitreoretinal surgery using the UNITY VCS Tetra-spot laser and the CONSTELLATION single-spot laser in patients with proliferative diabetic retinopathy (PDR) requiring panretinal photocoagulation (PRP).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of total laser application per laser spot applied (sec/1 spot)(During surgery)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo vitreous surgery for proliferative diabetic retinopathy during the study period, who have not received PRP or require additional PRP.
2. Patients expected to receive 2,000 to 4,000 laser shots during PRP.
3. Patients scheduled to undergo PRP from the vascular arcade to the peripheral retina (near the ora serrata).
4. Patients aged 20 years or older at the time of consent.
5. Patients who have provided written informed consent of their own free will to participate in this study.
Key exclusion criteria
1. Patients with retinal diseases other than diabetic retinopathy, such as retinal vein occlusion or uveitis
2. Patients with neovascular glaucoma
3. Patients using steroids or other anti-inflammatory drugs
4. Patients whose random blood glucose level is 350 mg/dL or higher, or whose HbA1c is greater than 10.0.
5. Patients with systemic complications that make imaging difficult
6. Patients deemed inappropriate for inclusion by the investigator
7. Patients who have expressed unwillingness to participate in this study, or whose legally authorized representatives have expressed such unwillingness
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Inoue |
Organization
Kyorin University Hospital (Kyorin Eye Center)
Division name
Department of Ophthalmology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka City, Tokyo
TEL
0422-47-5511
inoue-eye@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Inoue |
Organization
Kyorin University Hospital (Kyorin Eye Center)
Division name
Department of Ophthalmology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka City, Tokyo
TEL
0422-47-5511
Homepage URL
inoue-eye@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Hospital
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
School of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 05 | 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 | 10 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, prospective observational study designed to evaluate and compare the surgical efficiency and postoperative outcomes of panretinal photocoagulation (PRP) using the Tetra-spot laser (UNITY VCS) and the Single-spot laser (CONSTELLATION) during vitrectomy for proliferative diabetic retinopathy (PDR).
Participants will be consecutively enrolled into either the Tetra-spot or Single-spot laser group (16 eyes per group) based on clinical scheduling (e.g., surgical availability), not by research-driven allocation. Eligible patients are those undergoing vitrectomy for PDR at Kyorin University Hospital, Kyorin Eye Center, between October 2025 and June 2027, who meet the inclusion criteria.
Data will be collected from routine clinical examinations and surgical videos, including laser shot count, total laser application time, vitrectomy time (excluding laser), flare values, laser spot diameter (measured by OCT), and surgeon-reported ease-of-use scores for photocoagulation. Observations will be made preoperatively and at 1 week, 1 month, 2 months, and 3 months postoperatively, in accordance with standard clinical follow-up.
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068227
