Clinical Trial: 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 (Japan)

Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061678) titled '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' on June 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Sato Eye Clinic

Condition: Condition - age-related cataract Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 50 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 Size - 100

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070572

Disclaimer: Curated by HT Syndication.