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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
In arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification
In arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology
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)
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
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
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
The satisfaction will be assessed using a questionnaire
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
The comfort will be assessed using a questionnaire
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)
Aurélie DUSSAUSSOY, Clinical research associated
CONTACT
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