High-frequency pulsed vacuum versus phacoemulsification for bilateral cataract surgery
"Comparative Study of High-frequency Pulsed Vacuum Technology Versus Phacoemulsification for Cataract Surgery
This trial will test a new high-frequency pulsed vacuum technique against standard phacoemulsification in adults who need cataract surgery in both eyes to see if recovery is faster and surgery is safer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Victor Pauchet Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT07074431 on ClinicalTrials.gov |
What this trial studies
The study compares a novel high-frequency pulsed vacuum cataract ablation method with the widely used phacoemulsification technique in adults with bilateral grade 1–3 cataracts. The pulsed vacuum approach intermittently interrupts suction to create brief impact moments that dissect cataract material while aiming to preserve surrounding tissue and anterior chamber stability. Participants who meet eligibility will undergo cataract surgery and be followed for surgical outcomes, recovery speed, safety, and patient satisfaction. Key exclusions include advanced cataracts (> grade 3), uveitic cataract, glaucoma, other ocular comorbidities, inability to consent or complete questionnaires in French, and pregnancy.
Who should consider this trial
Good fit: Adults with bilateral cataracts graded 1 to 3 who are indicated for bilateral surgery, can read and understand French, and can give informed consent are ideal candidates.
Not a fit: Patients with cataract grade greater than 3, uveitic cataracts, glaucoma, other ocular comorbidities, unilateral or combined surgeries, or those unable to consent or read French are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could shorten recovery time and reduce intraoperative trauma and complications compared with standard phacoemulsification.
How similar studies have performed: Phacoemulsification is well established with strong evidence, while high-frequency pulsed vacuum is a novel technique with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amiens
- Clinique Victor Pauchet — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Aurélie DUSSAUSSOY, Clinical research associated
- Email: aurelie.dussaussoy@pauchet.com
- Phone: +33 3 22 33 74 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.