NCT06991374

Study on the Surgical Strategy of Corneal Endothelial Protection for Hard Nuclear Cataract Patients

Combined Burst Mode Versus Torsional Mode Phacoemulsification for Patients With Hard Nuclear Cataract: A Randomized Control Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

In this study, we compared two types of phacoemulsification commonly used in cataract surgery to evaluate their effect on the prognosis of patients with hard nuclei. This will provide a theoretical basis for selecting a more appropriate cataract surgery modality in practice in hard-nucleus patients.

Detailed description

In this study, we randomized patients into two groups. One group was the combined mode group in burst mode and the other group was the torsional ultrasound group in continuous mode. Cumulative dissipated energy(CDE) and ultrasound time(UST) were recorded during the procedure. Changes in central cornea thickness(CCT) and endothelial cell density(ECD) of the patients were recorded postoperatively during a 3-month follow-up. Intraoperative and postoperative complications were also recorded. The above data were analyzed to compare the effect of both on postoperative corneal recovery in patients with hard nuclei.

Conditions

• Hard Nuclear Cataract
• Phacoemulsification Cataract Surgery
• Endothelial Cell Density Loss
• Central Corneal Thickness

Interventions

Type	Name	Description
PROCEDURE	combined burst mode	the combined burst mode is commonly used in cataract phacoemulsification. This study compares whether the two modes have different outcomes in hard nuclear cataract surgery.
PROCEDURE	torsional mode	the toesional mode is commonly used in cataract phacoemulsification. This study compares whether the two modes have different outcomes in hard nuclear cataract surgery.

Timeline

• Start date: 2022-08-10
• Primary completion: 2024-12-25
• Completion: 2025-03-01
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: China