UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063109 |
|---|---|
| Receipt number | R000072244 |
| Scientific Title | Evaluation of Anterior Chamber Stability During Cataract Surgery Using Intraoperative Optical Coherence Tomography |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/30 01:10:42 |
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Basic information
Public title
Evaluation of Anterior Chamber Stability During Cataract Surgery Using Intraoperative OCT
Acronym
Intraocular Stability During Cataract Surgery
Scientific Title
Evaluation of Anterior Chamber Stability During Cataract Surgery Using Intraoperative Optical Coherence Tomography
Scientific Title:Acronym
Intraoperative OCT Assessment of Anterior Chamber Stability During Cataract Surgery
Region
| Japan |
Condition
Condition
Age-related cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare intraoperative anterior chamber stability between UNITY VCS and CENTURION Vision System in 50 patients with age-related cataract (50 eyes; 25 eyes per group). Preoperative and intraoperative data will be collected prospectively during routine clinical care. Iridocorneal angle dynamics during removal of the final nuclear fragment will be analyzed using intraoperative OCT recordings, and changes in iris diameter will be assessed using surgical videos.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of iridocorneal angle narrowing events of 10 degrees or greater per second during removal of the final nuclear fragment in cataract surgery, measured using intraoperative OCT.
Key secondary outcomes
Secondary outcome:
Change in iris diameter during removal of the final nuclear fragment in cataract surgery, assessed using surgical videos.
Exploratory outcomes:
1. Iridocorneal angle during removal of the final nuclear fragment, measured using intraoperative OCT
2. Intraoperative anterior chamber stability score (0-4), assessed using surgical videos
3. Ultrasound time
4. Aspiration time
5. Device-reported energy measures (CDE/Joules)
Device parameters will be recorded immediately after surgery.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 40 to 80 years with cataract who are scheduled to undergo phacoemulsification and intraocular lens implantation
2. Nuclear hardness of 2 to 3+ according to the EL classification
3. Patients who provide voluntary written informed consent to participate in the study
Key exclusion criteria
1. Corneal opacity
2. History of intraocular surgery
3. Zonular weakness
4. Risk of intraoperative complications
5. Small pupil diameter
6. Narrow iridocorneal angle (20 degrees or less)
7. Shallow anterior chamber (less than 2.8 mm)
8. Ocular inflammation or uveitis
9. Any other condition deemed unsuitable by the investigator
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
0422-47-5511
Homepage URL
koto@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
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
| 2026 | Year | 09 | Month | 30 | 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
| 2026 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | 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, cross-sectional observational study. Eligible patients undergoing cataract surgery with UNITY VCS or CENTURION Vision System at Kyorin University Hospital will be enrolled consecutively. The target sample size is 50 patients (50 eyes; 25 eyes per group), with one eye included per patient. Device selection is determined by routine clinical operations, including surgical scheduling, and is not assigned for research purposes. All surgeries will be performed by the same experienced surgeon.
Routine preoperative and intraoperative data, intraoperative OCT recordings, and surgical videos will be collected to examine the association between the surgical system used and anterior chamber stability. Iridocorneal angle dynamics and changes in iris diameter during removal of the final nuclear fragment will be analyzed using Dipp-MotionV (DITECT). The primary outcome is the frequency of angle narrowing events of 10 degrees or greater per second. Primary and secondary outcomes will be compared between groups using the Mann-Whitney U test.
This study builds on the assessment method used in the preceding study, "Evaluation of Anterior Chamber Stability Using Unity VCS in Cataract Surgery" (UMIN000059770), and compares UNITY VCS with CENTURION Vision System.
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072244
