"Comparative Study of High-frequency Pulsed Vacuum Technology Versus Phacoemulsification for Cataract Surgery
NCT ID: NCT07074431
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-31
2027-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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TECHNIC BY CATAPULSE
EYE 1 SURGERY BY CATAPULSE TECHNIC
In arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification
TECHNIC BY PHACOEMULSIFICATION
EYE 2 SURGERY BY CATAPULSE TECHNIC
In arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology
Interventions
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EYE 1 SURGERY BY CATAPULSE TECHNIC
In arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification
EYE 2 SURGERY BY CATAPULSE TECHNIC
In arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Clinique Victor Pauchet
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2024-A02793-44
Identifier Type: -
Identifier Source: org_study_id
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