Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063109) titled 'Evaluation of Anterior Chamber Stability During Cataract Surgery Using Intraoperative OCT' on Sept. 30.
Study Type:
Observational
Primary Sponsor:
Institute - Kyorin University
Condition:
Condition - Age-related cataract
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare intraoperative anterior chamber stability between UNITY VCS and CENTURION Vision System in 50 patients with age-related cataract (50 eyes; 25 eyes per group). Preoperative and intraoperative data will be collected prospectively during routine clinical care. Iridocorneal angle dynamics during removal of the final nuclear fragment will be analyzed using intraoperative OCT recordings, and changes in iris diameter will be assessed using surgical videos.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 40 to 80 years with cataract who are scheduled to undergo phacoemulsification and intraocular lens implantation
2. Nuclear hardness of 2 to 3+ according to the EL classification
3. Patients who provide voluntary written informed consent to participate in the study
Key exclusion criteria - 1. Corneal opacity
2. History of intraocular surgery
3. Zonular weakness
4. Risk of intraoperative complications
5. Small pupil diameter
6. Narrow iridocorneal angle (20 degrees or less)
7. Shallow anterior chamber (less than 2.8 mm)
8. Ocular inflammation or uveitis
9. Any other condition deemed unsuitable by the investigator
Target Size - 50
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 08 Month 18 Day
Date of IRB - 2026 Year 09 Month 28 Day
Anticipated trial start date - 2026 Year 09 Month 28 Day
Last follow-up date - 2028 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072244
Disclaimer: Curated by HT Syndication.