Clinical Trial: Prospective comparative study evaluating surgical efficiency and endothelial cell loss between the eight-chop technique and other nucleus disassembly techniques in phacoemulsification cataract surgery (Japan)

Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059907) titled 'Prospective comparative study evaluating surgical efficiency and endothelial cell loss between the eight-chop technique and other nucleus disassembly techniques in phacoemulsification cataract surgery' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Sato Eye Clinic

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

Objective: Narrative objectives1 - To comprehensively evaluate surgical efficiency, intraoperative parameters, and postoperative corneal endothelial safety of the eight-chop technique compared with other nucleus disassembly techniques (including phaco-chop and prechop) across a broad range of lens hardness (Emery-Little II-IV) in phacoemulsification cataract surgery. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Standard phacoemulsification cataract surgery using established nucleus disassembly techniques, including phaco-chop and/or prechop techniques. Machine settings, ophthalmic viscosurgical devices, and intraocular lens models will be kept as consistent as possible with the intervention arm. All surgeries will be performed by the same experienced surgeon. This arm serves as the active control group. Interventions/Control_2 - Standard phacoemulsification cataract surgery using established nucleus disassembly techniques, including phaco-chop and/or prechop techniques. Machine settings, ophthalmic viscosurgical devices, and intraocular lens models will be kept as consistent as possible with the intervention arm. All surgeries will be performed by the same experienced surgeon. This arm serves as the active control group.

Eligibility: Age-lower limit - 50 years-old

Gender - Male and Female Key inclusion criteria - Patients aged 50 years or older with age-related cataract.

Lens nucleus hardness graded II to IV according to the Emery-Little classification.

Preoperative corneal endothelial cell density >= 1800 cells/mm2, with reliable and reproducible specular microscopy measurements.

Ability to comply with all scheduled pre- and postoperative examinations, including visual acuity, corneal endothelial cell density, and anterior chamber flare measurements.

Absence of any ocular or systemic conditions that may interfere with the evaluation of surgical outcomes.

Written informed consent obtained after receiving a full explanation of the study procedures, risks, and benefits. Key exclusion criteria - Eyes with traumatic, congenital, or secondary cataracts other than age-related cataracts

Eyes with corneal diseases such as corneal degeneration, corneal dystrophy, corneal opacity, or Fuchs endothelial corneal dystrophy

Preoperative corneal endothelial cell density < 1800 cells/mm2 or unreliable measurements

History of intraocular surgery or ocular laser procedures (e.g., LASIK, PRK, SLT, glaucoma surgery) in the study eye

Severe amblyopia, active ocular inflammation, or ocular surface disorders (e.g., severe dry eye) that may interfere with postoperative evaluation

Eyes with coexisting ocular diseases such as glaucoma, diabetic retinopathy, or significant macular diseases (AMD, macular hole, epiretinal membrane, etc.)

Eyes requiring combined surgery other than intraocular lens implantation (e.g., glaucoma surgery, vitrectomy)

Eyes or patients with uncontrolled intraocular pressure, optic nerve disorders, or systemic conditions that substantially increase surgical risk

Patients unable to comply with the scheduled examinations or follow-up visits Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 01 Day Date of IRB - 2025 Year 11 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2030 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068377

Disclaimer: Curated by HT Syndication.