Lens DiseasesNCT07062107
Study on the Application of Adaptive Fluidics Technology in Lens Diseases Surgery
A study testing Conventional phacoemulsification surgery and Phacoemulsification using adaptive fluidics technology in people with Lens Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In phacoemulsification surgery for lens diseases using a traditional fluidics technology with a fixed perfusion pressure, the moment the perfusion needle enters the anterior chamber, the intraocular pressure will increase sharply. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lens Diseases
- What is being tested?
- Conventional phacoemulsification surgery and Phacoemulsification using adaptive fluidics technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 31 Dec 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lens opacity or abnormal position, with or without anterior segment structural changes, who meet the surgical indications and are aged between 18 and 80 years old and require lens surgery.
Who cannot join
- The patient has severe corneal scars or other corneal lesions, intraocular inflammation, and lesions of the retina, choroid, optic nerve, etc. that seriously affect the prognosis of vision. The patient has a clear history of systemic diseases affecting vision, a history of systemic medication, concurrent retinopathy, and other contraindications for conventional lens surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine,
Hangzhou, Zhejiang, 310009
About this study
Official title: Study on the Application of Adaptive Fluidics Technique in the Surgery of Lens Diseases
In phacoemulsification surgery for lens diseases using a traditional fluidics technology with a fixed perfusion pressure, the moment the perfusion needle enters the anterior chamber, the intraocular pressure will increase sharply. Moreover, the perfusion pressure cannot change along with the intraocular pressure during the operation, giving rise to many risks and threatening the safety of the surgery. The aim of this study is to apply adaptive fluidics technology to dynamically and precisely regulate the pressure and flow rate of the perfusion fluid, maintaining a relatively stable intraocular pressure during the operation. Meanwhile, intraoperative optical coherence tomography（OCT）was utilized to assist in observing the intraocular conditions, to study the advantages of adaptive fluidics technology in maintaining anterior chamber stability, and to verify the clinical application value of this technology in different types of lens diseases.
Read the detailed description
Phacoemulsification is currently the most commonly used surgical method for lens diseases. During the operation, it is necessary to continuously deliver perfusion fluids such as balanced salt solution into the eye (anterior chamber) to maintain the depth of the anterior chamber and the stability of intraocular pressure. The perfusion pressure of the traditional fluidics system is constant, which may lead to problems such as a sudden increase in intraocular pressure at the moment the perfusion needle enters the eye, thereby increasing the surgical risk and affecting the surgical outcome. How to ensure that the intraocular pressure of patients remains relatively stable during surgery, optimize the surgical process and achieve a better prognosis has received extensive attention from ophthalmology practitioners and researchers. The emergence and application of adaptive fluidics can dynamically optimize the pressure and flow rate of perfusion fluid during surgery, significantly reduce intraocular pressure fluctuations, and enhance the stability of the anterior chamber. At present, the relevant research on the application of adaptive fluid flow technology to assist in lens disease surgery is still scarce. Its exact application value and practical advantages still need to be fully verified and elaborated in detail through clinical trials, follow-up observations and other links. The aim of this study is to apply adaptive fluidics technology to dynamically and precisely regulate the pressure and flow rate of the perfusion fluid, maintaining a relatively stable intraocular pressure during the operation. Meanwhile, intraoperative optical coherence tomography（OCT）was utilized to assist in observing the intraocular conditions, to study the advantages of adaptive fluidics technology in maintaining anterior chamber stability, and to verify the clinical application value of this technology in different types of lens diseases.
- Conditions
- Lens Diseases
- Being tested
- Conventional phacoemulsification surgery, Phacoemulsification using adaptive fluidics technology
- Medical subject headings
- Lens Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional phacoemulsification surgeryProcedure or surgery
Also called Phacoemulsification using traditional fluidics
Conventional phacoemulsification surgery adopts the traditional perfusion system and uses intraoperative optical coherence tomography to assist in observation.
Phacoemulsification using adaptive fluidics technologyProcedure or surgery
Also called Phacoemulsification using adaptive fluidics
Phacoemulsification surgery adopts the adaptive fluidics system to precisely and dynamically control the pressure and flow rate of the perfusion fluid. During the operation, optical coherence tomography is used to assist in observing the stability of the anterior chamber.
| Study group | Role | What they receive |
|---|---|---|
| Traditional fluidics for phacoemulsification | Active comparator | Traditional fluidics systems are used for perfusion during phacoemulsification. Receives: Procedure: Conventional phacoemulsification surgery |
| Adaptive fluidics for phacoemulsification | Experimental | Adaptive fluidics technology are used for perfusion during phacoemulsification. Receives: Procedure: Phacoemulsification using adaptive fluidics technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time intraocular pressure changes during the operation
The variation range of intraocular pressure during phacoemulsification surgery, especially the intraocular pressure at the moment when the perfusion needle enters the anterior chamber.
Measured: During the operation
Quantify the measured values of ultrasonic energy exposure
Including average phacoemulsification energy, average phacoemulsification power, effective phacoemulsification time and total phacoemulsification time.
Measured: During the operation
The volume of perfusion fluid used during the operation
Including average perfusion time, average aspiration time, average flow rate and total liquid usage.
Measured: During the operation
Intraoperative OCT-assisted observation of anterior chamber depth changes
Using intraoperative OCT to evaluate the distance between the pupil margin and the corneal endothelium to measure the changes in anterior chamber depth.
Measured: During the operation
Secondary outcomes (6)
Technical indicators related to anterior segment OCT during the operation
Using intraoperative OCT to record the technical indicators related to the anterior segment.
Measured: During the operative
Intraocular pressure
Measured: 1day, 1 week, 1 month and 3 month postoperation
Successful implantation rate of intraocular lens
Implantation rate of intraocular lens after surgery
Measured: Through study completion, an average of 1 year
Intraocular lens position after implantation
The location of intraocular lens after surgery, observed through slit - lamp and anterior segment optical coherence tomography.
Measured: 1day, 1 week and 1 month postoperation
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart
Measured: 1day, 1 week, 1 month and 3month postoperation
Postoperative complication
Measured: 1 week, 1 month and 3month postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start20 Jul 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lens DiseasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062107
- Sponsor's protocol ID
- 2025-0063
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application of Adaptive Fluidics Technique in the Surgery of Lens Diseases
- ClinicalTrials.gov ID
- NCT07062107
- Acronym / sponsor ID
- 2025-0063
- Conditions
- Lens Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 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.
In phacoemulsification surgery for lens diseases using a traditional fluidics technology with a fixed perfusion pressure, the moment the perfusion needle enters the anterior chamber, the intraocular pressure will increase sharply. Moreover, the perfusion pressure cannot change along with the intraocular pressure during the operation, giving rise to many risks and threatening the safety of the surgery. The aim of this study is to apply adaptive fluidics technology to dynamically and precisely regulate the pressure and flow rate of the perfusion fluid, maintaining a relatively stable intraocular pressure during the operation. Meanwhile, intraoperative optical coherence tomography（OCT）was utilized to assist in observing the intraocular conditions, to study the advantages of adaptive fluidics technology in maintaining anterior chamber stability, and to verify the clinical application value of this technology in different types of lens diseases.
Detailed description
Phacoemulsification is currently the most commonly used surgical method for lens diseases. During the operation, it is necessary to continuously deliver perfusion fluids such as balanced salt solution into the eye (anterior chamber) to maintain the depth of the anterior chamber and the stability of intraocular pressure. The perfusion pressure of the traditional fluidics system is constant, which may lead to problems such as a sudden increase in intraocular pressure at the moment the perfusion needle enters the eye, thereby increasing the surgical risk and affecting the surgical outcome. How to ensure that the intraocular pressure of patients remains relatively stable during surgery, optimize the surgical process and achieve a better prognosis has received extensive attention from ophthalmology practitioners and researchers. The emergence and application of adaptive fluidics can dynamically optimize the pressure and flow rate of perfusion fluid during surgery, significantly reduce intraocular pressure fluctuations, and enhance the stability of the anterior chamber. At present, the relevant research on the application of adaptive fluid flow technology to assist in lens disease surgery is still scarce. Its exact application value and practical advantages still need to be fully verified and elaborated in detail through clinical trials, follow-up observations and other links. The aim of this study is to apply adaptive fluidics technology to dynamically and precisely regulate the pressure and flow rate of the perfusion fluid, maintaining a relatively stable intraocular pressure during the operation. Meanwhile, intraoperative optical coherence tomography（OCT）was utilized to assist in observing the intraocular conditions, to study the advantages of adaptive fluidics technology in maintaining anterior chamber stability, and to verify the clinical application value of this technology in different types of lens diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional fluidics for phacoemulsification | Active comparator | Procedure: Conventional phacoemulsification surgeryTraditional fluidics systems are used for perfusion during phacoemulsification. |
| Adaptive fluidics for phacoemulsification | Experimental | Procedure: Phacoemulsification using adaptive fluidics technologyAdaptive fluidics technology are used for perfusion during phacoemulsification. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with lens opacity or abnormal position, with or without anterior segment structural changes, who meet the surgical indications and are aged between 18 and 80 years old and require lens surgery.
Key exclusion criteria (1 listed)
- The patient has severe corneal scars or other corneal lesions, intraocular inflammation, and lesions of the retina, choroid, optic nerve, etc. that seriously affect the prognosis of vision. The patient has a clear history of systemic diseases affecting vision, a history of systemic medication, concurrent retinopathy, and other contraindications for conventional lens surgery.
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 |
|---|---|---|
| Conventional phacoemulsification surgeryAlso: Phacoemulsification using traditional fluidicsConventional phacoemulsification surgery adopts the traditional perfusion system and uses intraoperative optical coherence tomography to assist in observation. | Procedure or surgery | Traditional fluidics for phacoemulsification |
| Phacoemulsification using adaptive fluidics technologyAlso: Phacoemulsification using adaptive fluidicsPhacoemulsification surgery adopts the adaptive fluidics system to precisely and dynamically control the pressure and flow rate of the perfusion fluid. During the operation, optical coherence tomography is used to assist in observing the stability of the anterior chamber. | Procedure or surgery | Adaptive fluidics for phacoemulsification |
Primary outcome
Real-time intraocular pressure changes during the operation
Time frame: During the operation
The variation range of intraocular pressure during phacoemulsification surgery, especially the intraocular pressure at the moment when the perfusion needle enters the anterior chamber.
Quantify the measured values of ultrasonic energy exposure
Time frame: During the operation
Including average phacoemulsification energy, average phacoemulsification power, effective phacoemulsification time and total phacoemulsification time.
The volume of perfusion fluid used during the operation
Time frame: During the operation
Including average perfusion time, average aspiration time, average flow rate and total liquid usage.
Intraoperative OCT-assisted observation of anterior chamber depth changes
Time frame: During the operation
Using intraoperative OCT to evaluate the distance between the pupil margin and the corneal endothelium to measure the changes in anterior chamber depth.
6 secondary outcomes
Technical indicators related to anterior segment OCT during the operation
Time frame: During the operative
Intraocular pressure
Time frame: 1day, 1 week, 1 month and 3 month postoperation
Successful implantation rate of intraocular lens
Time frame: Through study completion, an average of 1 year
Intraocular lens position after implantation
Time frame: 1day, 1 week and 1 month postoperation
Visual function
Time frame: 1day, 1 week, 1 month and 3month postoperation
Postoperative complication
Time frame: 1 week, 1 month and 3month postoperation
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 15 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional phacoemulsification surgery and Phacoemulsification using adaptive fluidics technology in people with Lens Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time intraocular pressure changes during the operation (time frame: During the operation). The study lists 4 primary outcomes in all. 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 15 Dec 2025.