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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Victor Pauchet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient

Patient with bilateral cataracts

Grade 1 to 3 cataracts

Indication for bilateral cataract surgery

Disqualifiers

Refusal of consent

Cataract grade > 3

Unilateral and/or combined cataract surgery

Uveitic cataract

Trial design

Design model

Crossover

Treatments tested in this trial

  • Eye 1 by the Technique by high-frequency pulsed vacuum technology

    Procedure/Surgery

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

  • Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technology

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Technique by high-frequency pulsed vacuum technologyExperimental treatment 1 intervention
Group B: TECHNIC BY PHACOEMULSIFICATIONActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Endothelial cell count by specular microscopy after each surgery

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

Time frame
At Day30 (+/- 7 days)

Secondary outcomes

1

Visual acuity

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

Time frame
before each procedure, between day 1 and day 5 after each procedure, and day 30 (+/- 7 days) after each procedure
2

Measurement of postoperative inflammation

The measurement of inflammation is carried out using the SUN classification

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

Other outcomes

Sponsors and contacts

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