Clinical trial NCT06991374: Study on the Surgical Strategy of Corneal Endothelial Protection for Hard Nuclear Cataract Patients
Official title: Combined Burst Mode Versus Torsional Mode Phacoemulsification for Patients With Hard Nuclear Cataract: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 207
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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\&#39; 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

Primary outcomes:
measure: Endothelial cell density
timeFrame: At 1day, 1week, 1month, 3months postoperatively.
measure: central cornea thickness
timeFrame: At 1day, 1week, 1month, 3months postoperatively.
measure: ultrasound time
timeFrame: During cataract surgery
measure: cumulative dissipated energy
timeFrame: During cataract surgery
Secondary outcomes:
measure: best-corrected distance visual acuity
timeFrame: At 1day, 1week, 1month, 3months postoperatively.
measure: cornea edema
timeFrame: At 1day, 1week, 1month, 3months postoperatively.
measure: occlusion
timeFrame: during surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye and ENT Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital, Fudan University
name: Yinghong Ji, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.