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

NCT07062107 | Active Not Recruiting

• 1 other identifier: 2025-0063
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Lens Diseases

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  During the operation

Secondary Outcomes (6)

• Technical indicators related to anterior segment OCT during the operation

  During the operative

• Intraocular pressure

  1day, 1 week, 1 month and 3 month postoperation

• Successful implantation rate of intraocular lens

  Through study completion, an average of 1 year

• Intraocular lens position after implantation

  1day, 1 week and 1 month postoperation

• Visual function

  1day, 1 week, 1 month and 3month postoperation

Study Arms (2)

Traditional fluidics for phacoemulsification

ACTIVE COMPARATOR

Traditional fluidics systems are used for perfusion during phacoemulsification.

Procedure: Conventional phacoemulsification surgery

Adaptive fluidics for phacoemulsification

EXPERIMENTAL

Adaptive fluidics technology are used for perfusion during phacoemulsification.

Procedure: Phacoemulsification using adaptive fluidics technology

Interventions

Conventional phacoemulsification surgery PROCEDURE

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

Also known as: Phacoemulsification using traditional fluidics

Traditional fluidics for phacoemulsification

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.

Also known as: Phacoemulsification using adaptive fluidics

Adaptive fluidics for phacoemulsification

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine,

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Lens Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 14, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-06

Locations

CN (1)