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

Not Applicable

Completed

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

• Registration Number: NCT06991374
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief 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.

Study Timeline

• Study Start: 2022-08-10
• Primary Completion: 2024-12-25
• Study Completion: 2025-03-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• patients with age-related cataracts that were only classified by Emery-Little as nuclear hardness grade III-V.
• encompassed a minimum dilated pupil diameter of 7 mm or above, as well as a corneal endothelial cell count exceeding 1200/mm^2.
• Corneal morphology is normal and clear
• Informed consent is required prior to enrollment

Exclusion Criteria

• Those with white cataracts, histories of eye surgery, and eye diseases such as corneal pathology, uveitis, Fuchs' dystrophy, and glaucoma were excluded.
• Exclude those with comorbid ocular and systemic diseases that affect corneal endothelial cell function
• Exclude those with previous intraocular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endothelial cell density	At 1day, 1week, 1month, 3months postoperatively.	Endothelial cell density after cataract surgery.
central cornea thickness	At 1day, 1week, 1month, 3months postoperatively.	central cornea thickness after cataract surgery.
ultrasound time	During cataract surgery	ultrasound time during phacoemulsification.
cumulative dissipated energy	During cataract surgery	cumulative dissipated energy during phacoemulsification.

Secondary Outcome Measures

Name	Time	Method
best-corrected distance visual acuity	At 1day, 1week, 1month, 3months postoperatively.	best-corrected distance visual acuity after cataract surgery
cornea edema	At 1day, 1week, 1month, 3months postoperatively.	cornea edema after cataract surgery
occlusion	during surgery	occlusion during phacoemulsification

Trial Locations

Locations (1)

Eye and ENT Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China