NCT07062107

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Lens Diseases

Interventions

Type	Name	Description
PROCEDURE	Conventional phacoemulsification surgery	Conventional phacoemulsification surgery adopts the traditional perfusion system and uses intraoperative optical coherence tomography to assist in observation.
PROCEDURE	Phacoemulsification using adaptive fluidics technology	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.

Timeline

• Start date: 2025-07-20
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-07-14
• Last updated: 2025-12-15

Locations

1 site across 1 country: China