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

Clinique Victor Pauchet

Status: Not yet enrolling

Conditions: Cataract Bilateral

Treatments: Procedure: EYE 2 SURGERY BY CATAPULSE TECHNIC; Procedure: EYE 1 SURGERY BY CATAPULSE TECHNIC

Study type: Interventional

Funder types: Other

Identifiers

NCT07074431

2024-A02793-44

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

TECHNIC BY CATAPULSE

Experimental group

Treatment:

Procedure: EYE 1 SURGERY BY CATAPULSE TECHNIC

TECHNIC BY PHACOEMULSIFICATION

Active Comparator group

Treatment:

Procedure: EYE 2 SURGERY BY CATAPULSE TECHNIC