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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

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 - BBG-EIGHT Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061678
Enrollment
100
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

age-related cataract

Interventions

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

Sponsors

Sato Eye Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Difference in percentage corneal endothelial cell loss between BBG-stained and non-stained fellow eyes at 19 weeks postoperatively.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTsuyoshi Sato

Sato Eye Clinic Director

perfect-eightchop@sato-ganka.com047029822

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026