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

NCT07074431 | Recruiting

• 1 other identifier: 2024-A02793-44
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Bilateral

Outcome Measures

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

  At Day30 (+/- 7 days)

Secondary Outcomes (7)

• Visual acuity

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

• Measurement of postoperative inflammation

  Between Day 1 and Day 5 after each cataract surgery

• 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

Study Arms (2)

TECHNIC BY CATAPULSE

EXPERIMENTAL

Procedure: EYE 1 SURGERY BY CATAPULSE TECHNIC

TECHNIC BY PHACOEMULSIFICATION

ACTIVE COMPARATOR

Procedure: EYE 2 SURGERY BY CATAPULSE TECHNIC

Interventions

EYE 1 SURGERY BY CATAPULSE TECHNIC PROCEDURE

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

TECHNIC BY CATAPULSE

EYE 2 SURGERY BY CATAPULSE TECHNIC PROCEDURE

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

TECHNIC BY PHACOEMULSIFICATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Victor Pauchet: lead

Study Sites (1)

Clinique Victor Pauchet

Amiens, 80090, France

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Aurélie DUSSAUSSOY, Clinical research associated

CONTACT

+33 3 22 33 74 78; aurelie.dussaussoy@pauchet.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: July 20, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)