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

Eye & ENT Hospital of Fudan University

Status: Completed

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

Treatments: Procedure: torsional mode; Procedure: combined burst mode

Study type: Interventional

Funder types: Other

Identifiers

NCT06991374

Grant No. 81770907 & No. 82070 (Other Grant/Funding Number)

2013021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 50 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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207 participants in 2 patient groups

Combined burst mode

Experimental group

Description:

combining the torsional and vertical ultrasound under burst mode(Burst Tor+ Burst US) Phacoemulsification mode Brust mode Torsional amplitude 0-90% Longitudinal power 40% Infusion system Gravity fed Bottle height 50-80 cm Vacuum 360 mmHg Aspiration flow rate 30 cm3/min Burst duration 70 ms Off time 50 ms

Treatment:

Procedure: combined burst mode

torsional mode

Active Comparator group

Description:

torsional mode under continues mode (Linear Tor) Phacoemulsification mode Continuous mode Torsional amplitude 0-90% Longitudinal power 0 Infusion system Gravity fed Bottle height 50-80 cm Vacuum 360 mmHg Aspiration flow rate 30 cm3/min Burst duration - Off time -

Treatment:

Procedure: torsional mode