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

NCT ID: NCT07062107

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-20
• Study Completion Date: 2029-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional fluidics for phacoemulsification

Traditional fluidics systems are used for perfusion during phacoemulsification.

Group Type: ACTIVE_COMPARATOR

Conventional phacoemulsification surgery

Intervention Type: PROCEDURE

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

Adaptive fluidics for phacoemulsification

Adaptive fluidics technology are used for perfusion during phacoemulsification.

Group Type: EXPERIMENTAL

Phacoemulsification using adaptive fluidics technology

Intervention Type: 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.

Interventions

Conventional phacoemulsification surgery

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Phacoemulsification using traditional fluidics; Phacoemulsification using adaptive fluidics

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Second Affiliated Hospital, Zhejiang University School of Medicine,

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2025-0063

Identifier Type: -

Identifier Source: org_study_id