Second Affiliated Hospital, Zhejiang University School of Medicine,
Hangzhou, Zhejiang, 310009, China
NCT Number: NCT07062107
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310009, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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
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.
Time frame: During the operation
Including average phacoemulsification energy, average phacoemulsification power, effective phacoemulsification time and total phacoemulsification time.
Time frame: During the operation
Including average perfusion time, average aspiration time, average flow rate and total liquid usage.
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.
Time frame: During the operative
Using intraoperative OCT to record the technical indicators related to the anterior segment.
Time frame: 1day, 1 week, 1 month and 3 month postoperation
Time frame: Through study completion, an average of 1 year
Implantation rate of intraocular lens after surgery
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.
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
Time frame: 1 week, 1 month and 3month postoperation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Study on the Application of Adaptive Fluidics Technique in the Surgery of Lens Diseases
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