UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061678 |
|---|---|
| Receipt number | R000070572 |
| Scientific Title | Prospective paired-eye non-inferiority study evaluating the effects of 0.1% Brilliant Blue G anterior capsule staining on corneal endothelial cell loss and aqueous flare after low-stress Eight-Chop cataract surgery |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/06/01 06:33:17 |
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Basic information
Public title
Prospective paired-eye study evaluating the effects of 0.1% Brilliant Blue G anterior capsule staining on corneal endothelial cell loss and aqueous flare after low-stress Eight-Chop cataract surgery
Acronym
BBG Paired-Eye Study
Scientific Title
Prospective paired-eye non-inferiority study evaluating the effects of 0.1% Brilliant Blue G anterior capsule staining on corneal endothelial cell loss and aqueous flare after low-stress Eight-Chop cataract surgery
Scientific Title:Acronym
BBG-EIGHT Study
Region
| Japan |
Condition
Condition
age-related cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether 0.1% Brilliant Blue G (BBG) anterior capsule staining is non-inferior to no staining with respect to corneal endothelial cell loss and anterior chamber flare in patients undergoing low-stress cataract surgery using the Eight-Chop technique in a prospective paired-eye design.
In this study, both eyes of patients scheduled for bilateral cataract surgery will be operated on using a standardized low-stress Eight-Chop phacoemulsification protocol. One eye will receive 0.1% BBG anterior capsule staining, whereas the fellow eye will undergo cataract surgery without anterior capsule staining.
By comparing percentage endothelial cell loss, central corneal thickness, and aqueous flare values between BBG-stained and non-stained fellow eyes at predefined time points, the study aims to clarify the safety and utility of 0.1% BBG anterior capsule staining in routine cataract surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in percentage corneal endothelial cell loss between BBG-stained and non-stained fellow eyes at 19 weeks postoperatively.
Key secondary outcomes
1.Difference in percentage endothelial cell loss between fellow eyes at 7 weeks postoperatively
2.Changes in central corneal thickness (CCT) in each eye at 1 day, 7 days, 7 weeks, and 19 weeks
3.Aqueous flare values in each eye at preoperative baseline, 1 day, 7 days, 7 weeks, and 19 weeks
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
| Maneuver |
Interventions/Control_1
Cataract surgery is performed using the low-stress Eight-Chop phacoemulsification technique combined with 0.1% brilliant blue G (BBG) anterior capsule staining. The fellow eye without BBG staining in the same patient is used as an internal control for within-patient paired comparison.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo cataract surgery at Sato Eye Clinic
Patients with visually significant lens opacity in one or both eyes in whom cataract surgery is expected to improve visual function as judged by the investigator
Patients aged 50 to 90 years at the time of informed consent
Patients with corneal endothelial cell counts considered sufficient to tolerate routine cataract surgery as judged by the investigator
Patients in whom standard phacoemulsification and intraocular lens implantation are considered feasible based on anterior chamber depth, pupil size, and other anterior segment findings
Patients who have received both written and verbal information about the study and have provided written informed consent of their own free will
Key exclusion criteria
Patients with a low corneal endothelial cell count in whom cataract surgery is considered to carry a high risk of severe endothelial damage by the investigator
Patients with corneal opacity or corneal scarring that markedly reduces intraoperative visibility of the anterior capsule or lens nucleus
Eyes with markedly altered anterior segment anatomy, such as after glaucoma surgery or corneal transplantation
Patients with clinical findings strongly suggesting zonular weakness or lens subluxation in whom standard phacoemulsification cataract surgery is considered difficult by the investigator
Patients with uveitis or active intraocular inflammation
Patients with severe retinal diseases, such as proliferative diabetic retinopathy, in whom visual improvement after cataract surgery cannot be reliably evaluated
Patients who have previously undergone intraocular surgery, including cataract surgery, in the study eye
Patients who are pregnant or may be pregnant
Patients who are unable to understand the explanation of the study or who cannot provide written informed consent
Any other patients whom the investigator judges to be inappropriate for participation in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sato |
Organization
Sato Eye Clinic
Division name
Director
Zip code
2710077
Address
3-3 Nemoto, Matsudoshi, Chiba, Jpan
TEL
0477029822
perfect-eightchop@sato-ganka.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sato |
Organization
Sato Eye Clinic
Division name
Director
Zip code
2710077
Address
3-3 Nemoto, Matsudoshi, Chiba, Jpan
TEL
047029822
Homepage URL
perfect-eightchop@sato-ganka.com
Sponsor or person
Institute
Sato Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Sato Eye Clinic
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
Sato Eye Clinic
Address
3-3 Nemoto, Matsudoshi, Chiba, Jpan
Tel
0477029822
perfect-eightchop@sato-ganka.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
| 2026 | Year | 06 | Month | 01 | 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 | 05 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | 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
| 2026 | Year | 05 | Month | 25 | Day |
Last modified on
| 2026 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070572
