Tokyo, Dec. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060052) titled 'Comparison of Surgical Efficiency in Cataract Surgery Device' on Dec. 11.
Study Type:
Observational
Primary Sponsor:
Institute - Sakanishi Eye Clinic, Yoshihito Sakanishi
Condition:
Condition - Cataract
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to compare and evaluate the surgical efficiency of cataract surgery using CONSTELLATION and UNITY VCS in patients with cataracts
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Patients aged 40 to 90 years diagnosed with cataract who underwent phacoemulsification and intraocular lens implantation, gender is not restricted.
2.Patients with nuclear hardness graded up to 2 to 3 according to the Emery Little classification.
3. Patients in whom a monofocal intraocular lens or a toric intraocular lens was implanted.
Key exclusion criteria - 1. Patients who underwent other ocular surgeries within one month after cataract surgery, or with a history of ocular surgery including shallow anterior chamber, uveitis, progressive diabetic retinopathy, corneal degeneration, corneal transplantation, or corneal refractive surgery.
2. Patients with corneal endothelial cell density less than 1500 cells/mm2.
3.Patients in whom the IOL could not be completely fixed within the capsular bag during surgery.
4. Patients deemed inappropriate by the investigator due to systemic or ocular comorbidities.
Target Size - 126
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 08 Month 21 Day
Date of IRB - 2026 Year 08 Month 21 Day
Anticipated trial start date - 2025 Year 12 Month 11 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068674
Disclaimer: Curated by HT Syndication.
