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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional fluidics for phacoemulsification | Active Comparator | Traditional fluidics systems are used for perfusion during phacoemulsification. |
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| Adaptive fluidics for phacoemulsification | Experimental | Adaptive fluidics technology are used for perfusion during phacoemulsification. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional phacoemulsification surgery | Procedure | Conventional phacoemulsification surgery adopts the traditional perfusion system and uses intraoperative optical coherence tomography to assist in observation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical indicators related to anterior segment OCT during the operation | Using intraoperative OCT to record the technical indicators related to the anterior segment. | During the operative |
| Intraocular pressure |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, Zhejiang University School of Medicine, | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| 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. |
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| 1day, 1 week, 1 month and 3 month postoperation |
| Successful implantation rate of intraocular lens | Implantation rate of intraocular lens after surgery | Through study completion, an average of 1 year |
| Intraocular lens position after implantation | The location of intraocular lens after surgery, observed through slit - lamp and anterior segment optical coherence tomography. | 1day, 1 week and 1 month postoperation |
| Visual function | Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart | 1day, 1 week, 1 month and 3month postoperation |
| Postoperative complication | 1 week, 1 month and 3month postoperation |