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Recruiting NCT07074431

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

No phase Interventional Cataract Bilateral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EYE 1 SURGERY BY CATAPULSE TECHNIC, EYE 2 SURGERY BY CATAPULSE TECHNIC.
Who it may be relevant to
Registry conditions: Cataract Bilateral. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure EYE 1 SURGERY BY CATAPULSE TECHNIC
    In arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification
  • Procedure EYE 2 SURGERY BY CATAPULSE TECHNIC
    In arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology

Primary outcome measures

  • Endothelial cell count by specular microscopy after each surgery [Time frame: At Day30 (+/- 7 days)]
Secondary outcome measures (7)
  • Visual acuity [Time frame: before each procedure, between day 1 and day 5 after each procedure, and day 30 (+/- 7 days) after each procedure]
  • Measurement of postoperative inflammation [Time frame: Between Day 1 and Day 5 after each cataract surgery]
  • The rate of postoperative complications [Time frame: Between Day 1 and Day 5 after each cataract surgery, at Day30 (+/- 7 days)]
  • The operating times of each surgery [Time frame: Perioperative]
  • 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]
  • A Likert scale will be used to assess patient comfort during surgery [Time frame: Between Day 1 and Day 5 after each cataract surgery]
  • Adverse events related to both surgeries [Time frame: Between Day 1 and Day 5 after each cataract surgery and at Day30 (+/- 7 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Clinique Victor Pauchet — Amiens

Identifiers

NCT: NCT07074431 · 2024-A02793-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗