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Completed

NCT Number: NCT06991374

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

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.

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Key information

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Endothelial cell density

    Time frame: At 1day, 1week, 1month, 3months postoperatively.

    Endothelial cell density after cataract surgery.

  2. central cornea thickness

    Time frame: At 1day, 1week, 1month, 3months postoperatively.

    central cornea thickness after cataract surgery.

  3. ultrasound time

    Time frame: During cataract surgery

    ultrasound time during phacoemulsification.

  4. cumulative dissipated energy

    Time frame: During cataract surgery

    cumulative dissipated energy during phacoemulsification.

Secondary outcomes

  1. best-corrected distance visual acuity

    Time frame: At 1day, 1week, 1month, 3months postoperatively.

    best-corrected distance visual acuity after cataract surgery

  2. cornea edema

    Time frame: At 1day, 1week, 1month, 3months postoperatively.

    cornea edema after cataract surgery

  3. occlusion

    Time frame: during surgery

    occlusion during phacoemulsification

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

Combined Burst Mode Versus Torsional Mode Phacoemulsification for Patients With Hard Nuclear Cataract: A Randomized Control Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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