Clinical Trial: Effects of Aspiration Flow Rate on Corneal Endothelial Cell Loss and Postoperative Aqueous Flare in Eight-Chop Cataract Surgery: A Prospective Randomized Fellow-Eye Equivalence Trial (Japan)

Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063450) titled 'Effects of Aspiration Flow Rates of 32 and 40 mL/min on Corneal Endothelial Cell Loss and Postoperative Inflammation in Cataract Surgery' on Nov. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Dose comparison

Primary Sponsor: Institute - Sato Eye Clinic

Condition: Condition - Senile cataract Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate equivalence in corneal endothelial cell density loss at postoperative week 19 between aspiration flow settings of 32 and 40 mL/min during Eight-Chop phacoemulsification, using a prespecified equivalence margin of +/- 2.0 percentage points, and to compare postoperative aqueous flare and intraoperative parameters. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Aspiration flow rate of 32 mL/min. Eight-Chop phacoemulsification is performed using the Alcon Centurion system with a target intraocular pressure of 55 mmHg and a maximum vacuum of 500 mmHg. The intervention is applied once during cataract surgery in one eye. All other surgical settings and postoperative management are standardized between the two groups. Interventions/Control_2 - Aspiration flow rate of 40 mL/min. Eight-Chop phacoemulsification is performed using the Alcon Centurion system with a target intraocular pressure of 55 mmHg and a maximum vacuum of 500 mmHg. The intervention is applied once during cataract surgery in the fellow eye. All other surgical settings and postoperative management are standardized between the two groups.

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients aged 50 to 90 years, inclusive. 2. Patients with bilateral age-related cataracts scheduled for cataract surgery in both eyes. 3. Patients with Emery-Little nuclear sclerosis Grade II or III in both eyes. 4. Patients with preoperative corneal endothelial cell density of at least 1800 cells/mm2 in both eyes. 5. Patients available for postoperative follow-up through week 19. 6. Patients who provide written informed consent after receiving an explanation of the study. Key exclusion criteria - 1. Patients with diabetes mellitus. 2. Eyes with Emery-Little nuclear sclerosis Grade I or Grade IV or higher. 3. Eyes with corneal endothelial cell density below 1800 cells/mm2. 4. Patients with corneal disease, uveitis, glaucoma, or other ocular conditions that may affect the study outcomes. 5. Eyes with a history of intraocular surgery. 6. Eyes with traumatic or complicated cataracts. 7. Patients requiring additional intraocular surgery combined with cataract surgery. 8. Patients considered unsuitable for participation by the principal investigator. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 29 Day Anticipated trial start date - 2026 Year 12 Month 01 Day Last follow-up date - 2028 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072625

Disclaimer: Curated by HT Syndication.