Cataract BilateralPULSEMNCT07074431
"Comparative Study of High-frequency Pulsed Vacuum Technology Versus Phacoemulsification for Cataract Surgery
A study testing Eye 1 by the Technique by high-frequency pulsed vacuum technology and Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technology in people with Cataract Bilateral, run by Clinique Victor Pauchet at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Bilateral
- What is being tested?
- Eye 1 by the Technique by high-frequency pulsed vacuum technology and Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refusal of consent
- Cataract grade > 3
- Unilateral and/or combined cataract surgery
- Uveitic cataract
- Glaucoma
- Patient with ocular comorbidity
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aurélie DUSSAUSSOY, Clinical research associated contact
France1 site, 1 recruiting
- Recruiting
Clinique Victor Pauchet
Amiens, 80090
Aurélie DUSSAUSSOY, +33 3 22 33 74 78, aurelie.dussaussoy@pauchet.com
About this study
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.
Read more
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
- Being tested
- Eye 1 by the Technique by high-frequency pulsed vacuum technology, Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technology
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye 1 by the Technique by high-frequency pulsed vacuum technologyProcedure or surgery
In arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification
Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technologyProcedure or surgery
In arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology
| Study group | Role | What they receive |
|---|---|---|
| Technique by high-frequency pulsed vacuum technology | Experimental | Not described Receives: Procedure: Eye 1 by the Technique by high-frequency pulsed vacuum technology |
| TECHNIC BY PHACOEMULSIFICATION | Active comparator | Not described Receives: Procedure: Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Day30 (+/- 7 days)
Secondary outcomes (7)
Visual acuity
Vision is tested in distance and near vision, eye by eye, by masking with a patch
Measured: before each procedure, between day 1 and day 5 after each procedure, and day 30 (+/- 7 days) after each procedure
Measurement of postoperative inflammation
The measurement of inflammation is carried out using the SUN classification
Measured: Between Day 1 and Day 5 after each cataract surgery
The rate of postoperative complications
Measured: Between Day 1 and Day 5 after each cataract surgery, at Day30 (+/- 7 days)
The operating times of each surgery
Measured: Perioperative
Satisfaction with the use of high-frequency pulsed vacuum technology by healthcare teams
The satisfaction will be assessed using a questionnaire
Measured: Between Day 1 and Day 5 after each cataract surgery with the technique by high-frequency pulsed vacuum technology
A Likert scale will be used to assess patient comfort during surgery
The comfort will be assessed using a questionnaire
Measured: Between Day 1 and Day 5 after each cataract surgery
Adverse events related to both surgeries
Measured: Between Day 1 and Day 5 after each cataract surgery and at Day30 (+/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start12 Dec 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Victor Pauchet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074431
- Sponsor's protocol ID
- 2024-A02793-44
- Acronym
- PULSEM
- Status last verified
- Oct 2026
- First submitted
- 15 May 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparative Study of High-frequency Pulsed Vacuum Technology Versus Phacoemulsification for Cataract Surgery
- ClinicalTrials.gov ID
- NCT07074431
- Acronym / sponsor ID
- PULSEM / 2024-A02793-44
- Conditions
- Cataract Bilateral
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique Victor PauchetUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technique by high-frequency pulsed vacuum technology | Experimental | Procedure: Eye 1 by the Technique by high-frequency pulsed vacuum technology |
| TECHNIC BY PHACOEMULSIFICATION | Active comparator | Procedure: Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Refusal of consent
- Cataract grade > 3
- Unilateral and/or combined cataract surgery
- Uveitic cataract
- Glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye 1 by the Technique by high-frequency pulsed vacuum technologyIn arm 2: 1st eye operated by high-frequency pulsed vacuum technology / 2nd eye operated by phacoemulsification | Procedure or surgery | Technique by high-frequency pulsed vacuum technology |
| Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technologyIn arm 1: 1st eye operated by phacoemulsification / 2nd eye operated by high-frequency pulsed vacuum technology | Procedure or surgery | TECHNIC BY PHACOEMULSIFICATION |
Primary outcome
Endothelial cell count by specular microscopy after each surgery
Time frame: 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
7 secondary outcomes
Visual acuity
Time frame: before each procedure, between day 1 and day 5 after each procedure, and day 30 (+/- 7 days) after each procedure
Measurement of postoperative inflammation
Time frame: Between Day 1 and Day 5 after each cataract surgery
The rate of postoperative complications
Time frame: Between Day 1 and Day 5 after each cataract surgery, at Day30 (+/- 7 days)
The operating times of each surgery
Time frame: Perioperative
Satisfaction with the use of high-frequency pulsed vacuum technology by healthcare teams
Time frame: Between Day 1 and Day 5 after each cataract surgery with the technique by high-frequency pulsed vacuum technology
A Likert scale will be used to assess patient comfort during surgery
Time frame: Between Day 1 and Day 5 after each cataract surgery
Adverse events related to both surgeries
Time frame: Between Day 1 and Day 5 after each cataract surgery and at Day30 (+/- 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurélie DUSSAUSSOY, Clinical research associated contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye 1 by the Technique by high-frequency pulsed vacuum technology and Eye 2 : Surgery byTechnique by high-frequency pulsed vacuum technology in people with Cataract Bilateral, run by Clinique Victor Pauchet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie DUSSAUSSOY, Clinical research associated (+33 3 22 33 74 78, aurelie.dussaussoy@pauchet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell count by specular microscopy after each surgery (time frame: At Day30 (+/- 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.