Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06991374
Enrollment
207
Registered
2025-05-28
Start date
2022-08-10
Completion date
2025-03-01
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDUREcombined 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.

PROCEDUREtorsional 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.

Sponsors

Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelial cell densityAt 1day, 1week, 1month, 3months postoperatively.Endothelial cell density after cataract surgery.
central cornea thicknessAt 1day, 1week, 1month, 3months postoperatively.central cornea thickness after cataract surgery.
ultrasound timeDuring cataract surgeryultrasound time during phacoemulsification.
cumulative dissipated energyDuring cataract surgerycumulative dissipated energy during phacoemulsification.

Secondary

MeasureTime frameDescription
occlusionduring surgeryocclusion during phacoemulsification
best-corrected distance visual acuityAt 1day, 1week, 1month, 3months postoperatively.best-corrected distance visual acuity after cataract surgery
cornea edemaAt 1day, 1week, 1month, 3months postoperatively.cornea edema after cataract surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026