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NCT Number: NCT07062107

Study on the Application of Adaptive Fluidics Technology in Lens Diseases Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, Zhejiang University School of Medicine,

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Conventional phacoemulsification surgery

Procedure

Conventional phacoemulsification surgery adopts the traditional perfusion system and uses intraoperative optical coherence tomography to assist in observation.

Other names: Phacoemulsification using traditional fluidics

Phacoemulsification using adaptive fluidics technology

Procedure

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.

Other names: Phacoemulsification using adaptive fluidics

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Technical indicators related to anterior segment OCT during the operation

    Time frame: During the operative

    Using intraoperative OCT to record the technical indicators related to the anterior segment.

  2. Intraocular pressure

    Time frame: 1day, 1 week, 1 month and 3 month postoperation

  3. Successful implantation rate of intraocular lens

    Time frame: Through study completion, an average of 1 year

    Implantation rate of intraocular lens after surgery

  4. Intraocular lens position after implantation

    Time frame: 1day, 1 week and 1 month postoperation

    The location of intraocular lens after surgery, observed through slit - lamp and anterior segment optical coherence tomography.

  5. Visual function

    Time frame: 1day, 1 week, 1 month and 3month postoperation

    Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart

  6. Postoperative complication

    Time frame: 1 week, 1 month and 3month postoperation

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Study on the Application of Adaptive Fluidics Technique in the Surgery of Lens Diseases

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 14, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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