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

NCT06991374 | Completed DMC

• 2 other identifiers: 2013021Grant No. 81770907 & No. 82070
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hard nuclear cataract; phacoemulisification mode; ultrasound time; cumulative dissipated energy

Outcome Measures

Primary Outcomes (4)

• Endothelial cell density

  Endothelial cell density after cataract surgery.

  At 1day, 1week, 1month, 3months postoperatively.

• central cornea thickness

  central cornea thickness after cataract surgery.

  At 1day, 1week, 1month, 3months postoperatively.

• ultrasound time

  ultrasound time during phacoemulsification.

  During cataract surgery

• cumulative dissipated energy

  cumulative dissipated energy during phacoemulsification.

  During cataract surgery

Secondary Outcomes (3)

• best-corrected distance visual acuity

  At 1day, 1week, 1month, 3months postoperatively.

• cornea edema

  At 1day, 1week, 1month, 3months postoperatively.

• occlusion

  during surgery

Study Arms (2)

Combined burst mode

EXPERIMENTAL

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

Procedure: combined burst mode

torsional mode

ACTIVE COMPARATOR

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 -

Procedure: torsional mode

Interventions

combined burst mode PROCEDURE

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.

Combined burst mode

torsional mode PROCEDURE

the toesional mode is commonly used in cataract phacoemulsification. This study compares whether the two modes have different outcomes in hard nuclear cataract surgery.

torsional mode

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

• Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.

  PMID: 17276271 BACKGROUND

Study Officials

• Yinghong Ji, Phd

  Eye & ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: all individuals scheduled for cataract surgery were randomly allocated to either the combined mode group (Burst Tor+ Burst US, Group A) or the torsional mode group (Linear Tor, Group B), utilizing an online random number generator.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 28, 2025
• Study Start: August 10, 2022
• Primary Completion: December 25, 2024
• Study Completion: March 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2024.1.26, for 1month
• Access Criteria: researchers and public

Locations

CN (1)