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NCT Number: NCT07074431

"Comparative Study of High-frequency Pulsed Vacuum Technology Versus Phacoemulsification for Cataract Surgery

Cataracts are cloudings of the lens, primarily due to aging. Surgery is the primary treatment for cataracts. The most commonly used surgical technique is phacoemulsification, which involves fragmenting the lens using a high-frequency ultrasound probe and removing the fragments. Phacoemulsification is more common due to its advantages.

Recently, a new approach has emerged, using high-frequency pulsed vacuum technology for cataract ablation. This less invasive approach is expected to allow for faster patient recovery and reduce surgical risks. High-frequency pulsed vacuum utilizes the pulse-pulse principle by interrupting the vacuum every tenth of a second. This interruption creates an impact moment between the cataract material and the cannula tip, dissecting the cataract without damaging the surrounding delicate tissue. High-frequency pulsed vacuum maintains anterior chamber stability while creating sufficient dissection to aspirate the cataract material. This energy also cools the tip, allows for better vacuum control, and significantly reduces turbulence within the eye. More importantly, high-frequency pulsed vacuum disrupts endothelial cells less and causes less edema than mechanical ultrasound.

This technique therefore appears ideal for treating patients with at-risk corneas (low endothelial cell count, risk of decompensation and corneal transplantation).

The objective of the study is to demonstrate the benefits of this approach using high-frequency pulsed vacuum technology through a randomized, comparative, crossover study.

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Key information

Conditions

Cataract Bilateral Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient
  • Patient with bilateral cataracts
  • Grade 1 to 3 cataracts
  • Indication for bilateral cataract surgery
  • Patient informed of the study and having given their written and signed informed consent
  • Patient affiliated with a social security scheme or beneficiary of such a scheme

Exclusion criteria

  • Refusal of consent
  • Cataract grade > 3
  • Unilateral and/or combined cataract surgery
  • Uveitic cataract
  • Glaucoma
  • Patient with ocular comorbidity
  • Patient with cognitive impairment preventing them from responding to satisfaction questionnaires
  • Patient unable to read, write, or understand French
  • Pregnant or breastfeeding patient as defined in Article L1121-5 of the French Public Health Code
  • Vulnerable patient as defined in Article L1121-6 of the French Public Health Code
  • Adult patient under guardianship, curatorship, or legal protection
  • Patient unable to give personal consent

Treatment and study plan

EYE 1 SURGERY BY CATAPULSE TECHNIC

Procedure

In arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification

EYE 2 SURGERY BY CATAPULSE TECHNIC

Procedure

In arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology

Primary outcomes

  1. Endothelial cell count by specular microscopy after each surgery

    Time frame: At Day30 (+/- 7 days)

    The patient is placed in front of a mirror microscope, the chin resting on a chin rest, the ophthalmologist observes the endothelial layer of the cornea through the microscope, he manually counts the endothelial cells and assesses their density

Secondary outcomes

  1. Visual acuity

    Time frame: before each procedure, between day 1 and day 5 after each procedure, and day 30 (+/- 7 days) after each procedure

    Vision is tested in distance and near vision, eye by eye, by masking with a patch

  2. Measurement of postoperative inflammation

    Time frame: Between Day 1 and Day 5 after each cataract surgery

    The measurement of inflammation is carried out using the SUN classification

  3. The rate of postoperative complications

    Time frame: Between Day 1 and Day 5 after each cataract surgery, at Day30 (+/- 7 days)

  4. The operating times of each surgery

    Time frame: Perioperative

  5. Satisfaction with the use of high-frequency pulsed vacuum technology by healthcare teams

    Time frame: Between Day 1 and Day 5 after each cataract surgery with CATAPULSE

    The satisfaction will be assessed using a questionnaire

  6. A Likert scale will be used to assess patient comfort during surgery

    Time frame: Between Day 1 and Day 5 after each cataract surgery

    The comfort will be assessed using a questionnaire

  7. Adverse events related to both surgeries

    Time frame: Between Day 1 and Day 5 after each cataract surgery and at Day30 (+/- 7 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie DUSSAUSSOY, Clinical research associated

CONTACT

[email protected]

+33 3 22 33 74 78

Sponsors and collaborators

Lead sponsor

Clinique Victor Pauchet

Other

Registry information

Acronym: PULSEM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Mar 31, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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