Cataract Bilateral
Conditions
Brief summary
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
PROCEDUREEYE 1 SURGERY BY CATAPULSE TECHNIC
In arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification
PROCEDUREEYE 2 SURGERY BY CATAPULSE TECHNIC
In arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology
Sponsors
Clinique Victor Pauchet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial cell count by specular microscopy after each surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 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 |
| Measurement of postoperative inflammation | Between Day 1 and Day 5 after each cataract surgery | The measurement of inflammation is carried out using the SUN classification |
| The rate of postoperative complications | Between Day 1 and Day 5 after each cataract surgery, at Day30 (+/- 7 days) | — |
| The operating times of each surgery | Perioperative | — |
| Satisfaction with the use of high-frequency pulsed vacuum technology by healthcare teams | Between Day 1 and Day 5 after each cataract surgery with CATAPULSE | The satisfaction will be assessed using a questionnaire |
| A Likert scale will be used to assess patient comfort during surgery | Between Day 1 and Day 5 after each cataract surgery | The comfort will be assessed using a questionnaire |
| Adverse events related to both surgeries | Between Day 1 and Day 5 after each cataract surgery and at Day30 (+/- 7 days) | — |
Countries
France
Contacts
CONTACTAurélie DUSSAUSSOY, Clinical research associated
Outcome results
None listed