UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059770 |
|---|---|
| Receipt number | R000068345 |
| Scientific Title | Evaluation of Anterior Chamber Stability Using Unity VCS in Cataract Surgery |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 17:31:18 |
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Basic information
Public title
Evaluation of Anterior Chamber Stability Using Unity VCS in Cataract Surgery
Acronym
Evaluation of Anterior Chamber Stability Using Unity VCS in Cataract Surgery
Scientific Title
Evaluation of Anterior Chamber Stability Using Unity VCS in Cataract Surgery
Scientific Title:Acronym
Evaluation of Anterior Chamber Stability Using Unity VCS in Cataract Surgery
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective observational study used Unity VCS to continuously collect preoperative and intraoperative data from 50 cataract surgery cases, aiming to evaluate anterior chamber stability during cataract surgery. Anterior chamber stability was assessed using the Total Chamber Stability Score, determined from surgical videos. Additionally, intraoperative OCT recordings were used to evaluate angle movement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anterior Chamber Stability Score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Obtain informed consent
Classify nuclear hardness preoperatively using the EL classification with a slit-lamp microscope
Cataract surgery is performed by a single experienced surgeon (KT)
The anterior chamber stability score during cataract surgery is assessed from the surgical video. The score classification is as follows, with score 0 indicating the most stable state
0:No change in anterior chamber depth
1:Minimal change in anterior chamber depth (change in distance from the anterior capsule or posterior capsule to the corneal endothelium less than 50% of the tip diameter)
2: Significant change in anterior chamber depth (change in distance from the anterior surface of the nucleus or posterior capsule to the corneal endothelium less than 50% of the tip diameter)
3: Posterior capsule aspiration without posterior capsule rupture
4: Posterior capsule aspiration with posterior capsule rupture
ï½¥Intraoperative OCT
Intraoperative OCT recording shall be performed during surgery. The recorded intraoperative OCT video shall be used to analyze the angle of the anterior chamber over time using Dipp-MotionV Software (DITECT). Conditions where the angle is narrow or where there is significant fluctuation in the angle are considered unstable. Conditions where the angle is well-opened and where there is minimal fluctuation in the angle are considered stable
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 40 to 80 years diagnosed with cataracts undergoing phacoemulsification and intraocular lens implantation
Cases with EL classification nuclear hardness of 2-3+
Patients who provided written informed consent of their own free will to participate in this study
Key exclusion criteria
Patients with corneal opacity
Patients with a history of intraocular surgery
Patients with weak zonules
Patients at risk for intraoperative complications
Patients with small pupil diameter
Patients with narrow angles (20 degree or less)
Patients with shallow anterior chambers (less than 2.8mm)
Patients with ocular inflammation or uveitis
Other patients deemed unsuitable by the physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koto |
Organization
Kyorin University School of Medicine
Division name
Department of Ophthalmology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
koto@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Koto |
Organization
Kyorin University School of Medicine
Division name
Department of Ophthalmology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422475511
Homepage URL
koto@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
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
0422475511
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 | 13 | 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 | 11 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 13 | 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
Management information
Registered date
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068345
