Tokyo, Nov. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059658) titled 'Evaluation of Efficacy and Safety of a Novel Ultrasonic Phacoemulsification Unit' on Nov. 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - University of Tsukuba
Condition:
Condition - cataract
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the efficacy and safety of an ultrasonic phacoemulsification unit newly released in 2025 with existing surgical devices.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - cataract surgery with UNITY
Interventions/Control_2 - cataract surgery with Centurion
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - Patients without ocular or systemic comorbidities who are candidates for routine cataract surgery.
Key exclusion criteria - Patients with comorbidities that affect the surgical procedure and postoperative outcomes, and those who cannot complete the postoperative questionnaire.
Target Size - 40
Recruitment Status:
Recruitment status - Terminated
Date of protocol fixation - 2025 Year 06 Month 23 Day
Date of IRB - 2025 Year 06 Month 23 Day
Anticipated trial start date - 2025 Year 11 Month 06 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=R000068243
Disclaimer: Curated by HT Syndication.
