Tokyo, Nov. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059770) titled 'Evaluation of Anterior Chamber Stability Using Unity VCS in Cataract Surgery' on Nov. 13.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyorin University School of Medicine

Condition: Condition - Cataract Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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 ･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

Eligibility: Age-lower limit - 40 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 Size - 50

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068345

Disclaimer: Curated by HT Syndication.