Method and device for predicting and adjusting arch height after ICL operation

Abstract

The invention provides an ICL postoperative arch height prediction and adjustment method and device, and the method comprises the steps: a data obtaining step: obtaining eye anatomical data of a patient, including the diameters of a short axis and a long axis of a ciliary sulcus; acquiring state data of the current implanted ICL, wherein the state data comprises a nominal size and a rotation angle in an eye; a geometric modeling and calculation step: establishing a two-dimensional geometric model of the ICL in the elliptical ciliary sulcus based on the nominal size of the ICL and the diameters of the long and short axes of the ciliary sulcus, calculating the diagonal length limited by four supporting leg points of the ICL on the model according to the rotation angle of the ICL in the eye, and further calculating the theoretical geometric arch height; and an adjustment scheme generation step: on the basis of the calculated theoretical geometric arch height, generating at least one secondary operation adjustment scheme for adjusting the actual postoperative arch height to be within a clinical ideal range, the adjustment scheme comprising rotating the current ICL to a new angle or replacing the current ICL with another ICL with a different size.

Description

Technical Field

[0001] This invention relates to the field of vision correction surgery technology, specifically to a method and device for predicting and adjusting the arch height after ICL surgery. Background Technology

[0002] In recent years, with the rapid development of refractive surgery techniques, implantable collamer lens (ICL) surgery has become one of the important methods for correcting moderate to high myopia, hyperopia, and astigmatism. ICL surgery involves implanting a precise artificial lens into the patient's eye to correct vision. It has advantages such as not cutting the cornea, high reversibility, and high visual quality, making it increasingly popular among patients with refractive errors. In ICL surgery, postoperative arch height is a crucial parameter. Arch height is defined as the vertical distance between the posterior surface of the ICL and the anterior surface of the patient's natural lens. An ideal arch height range (clinically considered to be between 250μm and 750μm, with an optimal value around 500μm) is essential for ensuring the long-term safety and effectiveness of the surgery. Too low an arch height may cause the ICL to contact the natural lens, increasing the risk of subcapsular cataracts or affecting aqueous humor circulation; while too high an arch height may cause the ICL to rub against the posterior surface of the iris, leading to pigment dissemination, secondary glaucoma, or even angle stenosis or closure, and may also affect...

[0003] It affects the health of corneal endothelial cells. Accurately predicting and achieving the ideal postoperative arch is one of the key aspects of successful ICL surgery.

[0004] However, numerous and complex factors influence postoperative arch height, including individual differences in the patient's ocular anatomy (such as ciliary sulcus diameter, anterior chamber depth, and lens position), the size and model of the selected ICL, and the actual implantation position and rotation angle of the ICL within the eye. Currently, clinical practice primarily relies on preoperative measurements (such as white-to-white corneal diameter (WTW), anterior chamber depth (ACD), and ciliary sulcus-to-ciliary sulcus diameter (STS)) combined with calculation formulas provided by the manufacturer or an online calculation system (OCOS) to select the ICL size. However, some patients still experience unsatisfactory postoperative arch height, requiring secondary surgery for adjustment. Secondary adjustments may involve rotating a non-Toric ICL or replacing the ICL size. For Toric ICLs (TICLs), because they are designed to correct astigmatism, their rotation angle within the eye is strictly controlled; therefore, arch height is usually only adjusted by replacing the ICL with a different size. For non-Toric ICLs, if the arch height is unsatisfactory, clinicians may consider rotating the ICL to a new angle or replacing it with a different size. Rotating the ICL is less invasive and carries lower risk compared to replacing the ICL.

[0005] However, accurately predicting the change in arch height after rotation or resizing has always been a challenge in clinical practice. Traditional adjustment strategies are often based on experience or simplified linear assumptions, which may ignore the actual geometry of the ICL and its complex biomechanical behavior within the eye. Summary of the Invention

[0006] To address the shortcomings of existing technologies, the present invention aims to provide a method and device for predicting and adjusting the arch height after ICL surgery. This method and device can provide a secondary adjustment plan for patients who have undergone ICL implantation and have unsatisfactory arch height. This will assist clinicians in developing a more scientific and accurate secondary surgical plan to achieve a more ideal postoperative arch height, thereby improving the success rate of surgery and patient satisfaction.

[0007] To solve the above problems, the technical solution of the present invention is as follows:

[0008] A method for predicting and adjusting the arch height after ICL surgery includes the following steps:

[0009] Data acquisition steps: Acquire the patient's ocular anatomy data, including the short and long axis diameters of the ciliary sulcus; acquire the current status data of the implanted ICL, including its nominal size and rotation angle within the eye;

[0010] Geometric modeling and calculation steps: Based on the nominal size of the ICL and the major and minor axis diameters of the ciliary sulcus, a two-dimensional geometric model of the ICL in the elliptical ciliary sulcus is established. According to the rotation angle of the ICL in the eye, the diagonal lengths defined by the four support points of the ICL are calculated on the model, and then the theoretical geometric arch height is calculated.

[0011] Adjustment scheme generation steps: Based on the calculated theoretical geometric arch height, at least one secondary surgical adjustment scheme is generated to adjust the actual postoperative arch height to the clinically ideal range. The adjustment scheme includes rotating the current ICL to a new angle or replacing it with another ICL of a different size.

[0012] Preferably, the data acquisition step specifically includes:

[0013] The short axis diameter of the ciliary sulcus refers to the diameter of the patient's ciliary sulcus in the horizontal direction;

[0014] The long axis diameter of the ciliary sulcus refers to the diameter of the patient's ciliary sulcus in the vertical direction;

[0015] The specific parameters of the ICL implanted during the patient's initial surgery include:

[0016] The nominal size of ICL refers to the nominal size specified by the manufacturer for the currently implanted ICL;

[0017] ICL arch height refers to the natural arch height formed by the diagonal structure of the ICL when it is not constrained by the intraocular structure.

[0018] Current ICL central thickness refers to the thickness of the central optical zone of the currently implanted ICL.

[0019] Preferably, in the geometric modeling and calculation step, the theoretical clinical arch height is obtained by subtracting the central thickness of the ICL and the distance from the anterior surface of the lens to the ciliary sulcus plane from the theoretical geometric arch height. The effect of the secondary adjustment scheme is quantified by comparing the difference between the theoretical clinical arch height before and after the adjustment.

[0020] Preferably, the adjustment scheme generation step specifically includes: comparing the actual postoperative arch height input by the user with the preset clinical ideal range, giving a preliminary judgment; if the actual postoperative arch height exceeds the ideal range, then providing an intelligent adjustment scheme according to the ICL type:

[0021] For TICL, when the arch height is not ideal, we provide suggestions to replace it with a different size and predict the change in arch height after the replacement;

[0022] For non-TICL (Integrated Tier Clamping), when the arch height is not ideal, the solution of adjusting by rotating the ICL is given priority. The optimal rotation angle to achieve the target arch height is calculated and recommended, and the change in arch height after rotation is predicted. At the same time, changing the size of the ICL is also provided as an alternative solution, and its effect is predicted.

[0023] Furthermore, the present invention also provides a device for predicting and adjusting the arch height after ICL surgery, comprising:

[0024] Data interface module: used to receive the patient's ocular anatomy data, including the short and long axis diameters of the ciliary sulcus; and the current status data of the implanted ICL, including its nominal size and rotation angle within the eye;

[0025] Modeling and calculation module: It is configured to establish a two-dimensional geometric model of the ICL in the elliptical ciliary sulcus based on the nominal size of the ICL and the major and minor axis diameters of the ciliary sulcus; and calculate the diagonal length defined by the four support points of the ICL on the model according to the rotation angle of the ICL in the eye, and then calculate the theoretical geometric arch height.

[0026] Adjustment scheme generation module: configured to generate at least one secondary surgical adjustment scheme based on the calculated theoretical geometric arch height, which aims to adjust the actual postoperative arch height to the clinically ideal range, the adjustment scheme including rotating the current ICL to a new angle or replacing it with another ICL of a different size.

[0027] Preferably, the adjustment scheme includes: if the current actual arch height is too low, it is recommended to replace it with a larger standard ICL size; if the current actual arch height is too high, it is recommended to replace it with a smaller standard ICL size.

[0028] Preferably, the adjustment scheme includes:

[0029] Rotate the ICL according to the recommended rotation angle to make its adjusted clinical arch as close as possible to the clinical target value.

[0030] If the rotation does not achieve the desired effect, or if the doctor wishes to consider changing the size, it is recommended to change to a standard ICL size that is one size larger or smaller, depending on the difference between the current actual arch height and the target arch height.

[0031] Compared with existing technologies, this invention establishes a theoretical calculation baseline based on the input patient's ocular anatomy parameters, the parameters of the ICL implanted in the initial surgery, and the actual postoperative arch height. Based on the core assumption that the theoretically calculated change in arch height can better approximate the actual change in arch height after clinical adjustment, this invention provides quantitative predictions of arch height changes for different secondary adjustment schemes (rotating non-TICL or changing the size of ICL / TICL), thereby assisting clinicians in formulating secondary surgical plans more scientifically and accurately in order to achieve a more ideal postoperative arch height, improve surgical success rate, and increase patient satisfaction. Attached Figure Description

[0032] Other features, objects, and advantages of the present invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings:

[0033] Figure 1 This is a flowchart of the method for predicting and adjusting the arch height after ICL surgery according to the present invention;

[0034] Figure 2 This is a model diagram of the ICL of the present invention;

[0035] Figure 3 This is a structural block diagram of the ICL postoperative arch height prediction and adjustment device of the present invention. Detailed Implementation

[0036] The present invention will now be described in detail with reference to specific embodiments. These embodiments will help those skilled in the art to further understand the present invention, but do not limit the invention in any way. It should be noted that those skilled in the art can make several changes and improvements without departing from the concept of the present invention. These all fall within the protection scope of the present invention.

[0037] Specifically, this invention proposes a method for predicting and adjusting the arch height after ICL surgery. This invention is mainly applicable to cases that have undergone ICL implantation and require secondary surgery for adjustment due to unsatisfactory postoperative arch height (too high or too low). It assists ophthalmologists in making clinical decisions through theoretical calculations. Its core is to use the theoretically calculated change in arch height to predict the actual change in arch height after clinical adjustment.

[0038] like Figure 1 As shown, the method for predicting and adjusting the arch height after ICL surgery includes the following steps:

[0039] S1: Data acquisition steps: Acquire the patient's ocular anatomy data, including the short and long axis diameters of the ciliary sulcus; acquire the current status data of the implanted ICL, including its nominal size and rotation angle within the eye;

[0040] Specifically, the short axis diameter of the ciliary sulcus refers to the horizontal diameter of the patient's ciliary sulcus, which is generally considered to be the short axis of an elliptical ciliary sulcus. This data is usually obtained by preoperative high-frequency ultrasound biomicroscopy or other anterior segment imaging equipment.

[0041] The major axis diameter of the ciliary sulcus refers to the vertical diameter of the patient's ciliary sulcus, and is generally considered to be the major axis of an elliptical ciliary sulcus. The ellipticity of the ciliary sulcus directly affects the range of change in the arch height during ICL rotation.

[0042] The distance between the anterior surface of the lens and the ciliary sulcus plane refers to the vertical distance from the vertex of the anterior surface of the natural lens to the ciliary sulcus plane. This parameter reflects the position of the lens relative to the ciliary sulcus and is crucial for calculating the final clinical arch height.

[0043] The specific parameters of the ICL implanted during the patient's initial surgery include:

[0044] The nominal size of an ICL refers to the size specified by the manufacturer for the currently implanted ICL, which usually corresponds to the straight-line length of the ICL diagonal.

[0045] The inherent arch height of the ICL refers to the natural arch height formed by the diagonal structure of the ICL when it is not constrained by intraocular structures. This parameter, together with the nominal dimensions of the ICL, determines the inherent arc length of the ICL's diagonal.

[0046] The angle between the current reference principal axis (ef) of the implanted ICL and the horizontal direction of the eyeball: such as Figure 2 As shown, obtain the angle β between the line connecting the ICL's support feet (ac or bd) and the reference principal axis (ef). β is the inherent angle of the ICL itself. If the ICL rotates, the angle between ef and the horizontal direction of the eyeball, i.e., how many degrees of rotation, can be expressed by α.

[0047] Current ICL central thickness refers to the thickness of the central optical zone of the currently implanted ICL.

[0048] The actual clinical measurement data of the patient after the initial surgery specifically include:

[0049] The actual postoperative arch height refers to the central arch height value actually measured by anterior segment OCT and other equipment after the patient's initial ICL surgery.

[0050] ICL type: Whether the currently implanted ICL is a regular ICL or a TICL.

[0051] S2: Geometric modeling and calculation steps: Based on the nominal size of the ICL and the major and minor axis diameters of the ciliary sulcus, a two-dimensional geometric model of the ICL in the elliptical ciliary sulcus is established. According to the rotation angle of the ICL in the eye, the diagonal lengths defined by the four support points of the ICL are calculated on the model, and then the theoretical geometric arch height is calculated.

[0052] Specifically, when calculating the geometric arch height of the ICL due to deformation within the ciliary sulcus, the interaction between the two dominant diagonals of the ICL and the ciliary sulcus is simultaneously evaluated, and the diagonal that spans the shorter effective ciliary sulcus chord is selected to determine the final theoretical geometric arch height. This mechanism allows the model to more accurately reflect the symmetry of the ICL and its actual stress and deformation state within the asymmetric cavity, ensuring, for example, a theoretically symmetrical arch height prediction when the ICL principal axes are rotated symmetrically (e.g., ±10°).

[0053] The theoretical clinical arch height is based on the theoretical geometric arch height, further taking into account the influence of two clinically relevant parameters: the central thickness of the ICL and the STSL (distance from the anterior surface of the lens to the ciliary sulcus plane). The theoretical clinical arch height is obtained by subtracting the central thickness of the ICL and the STSL value from the theoretical geometric arch height.

[0054] When evaluating a secondary adjustment, the procedure calculates two theoretical clinical arch height values: one before the adjustment (current state) and one after the adjustment (new dimensions or angles). The difference between these two theoretical clinical arch height values ​​is considered the theoretical change in arch height. Ultimately, the estimated new clinical arch height is obtained by adding this theoretical change in arch height to the patient's current actual postoperative arch height.

[0055] S3: Adjustment plan generation step: Based on the calculated theoretical geometric arch height, generate at least one secondary surgical adjustment plan aimed at adjusting the actual postoperative arch height to the clinically ideal range. The adjustment plan includes rotating the current ICL to a new angle or replacing it with another ICL of a different size.

[0056] Specifically, the actual postoperative arch height input by the user is compared with the preset clinical ideal range (0.250mm-0.750mm) to provide a preliminary judgment. If the actual postoperative arch height exceeds the ideal range, an intelligent adjustment plan is provided based on the ICL type.

[0057] For TICL, if the arch height is not ideal, we suggest replacing it with a different size and predict the change in arch height after replacement (which needs to be combined with the expected implantation angle of the new TICL).

[0058] For non-TICL (Integrated Tier Clamping), when the arch height is not ideal, the solution of adjusting by rotating the ICL is given priority. The optimal rotation angle to achieve the target arch height is calculated and recommended, and the change in arch height after rotation is predicted. At the same time, changing the size of the ICL is also provided as an alternative solution, and its effect is predicted.

[0059] Furthermore, the present invention also provides a device for predicting and adjusting the arch height after ICL surgery, such as... Figure 3 As shown, the device includes: a data interface module 1, a modeling and calculation module 2, and an adjustment scheme generation module 3.

[0060] 1. Data Interface Module: Used to receive the patient's ocular anatomy data, including the short and long axis diameters of the ciliary sulcus; and the current status data of the implanted ICL, including its nominal size and rotation angle within the eye;

[0061] 2. Modeling and Calculation Module: Configured to establish a two-dimensional geometric model of the ICL within an elliptical ciliary sulcus based on the nominal dimensions of the ICL and the major and minor axis diameters of the ciliary sulcus; and to calculate the diagonal lengths defined by the four support points of the ICL on the model according to the rotation angle of the ICL within the eye, thereby calculating the theoretical geometric arch height;

[0062] 3. Adjustment scheme generation module: configured to generate at least one secondary surgical adjustment scheme based on the calculated theoretical geometric arch height, which aims to adjust the actual postoperative arch height to the clinically ideal range. The adjustment scheme includes rotating the current ICL to a new angle or replacing it with another ICL of a different size.

[0063] TICL Adjustment Recommendations

[0064] If the user selects TICL as the ICL type and the evaluation result suggests adjustment, this module will provide adjustment suggestions. TICL cannot adjust the arch height by rotation; it can only suggest changing the ICL size.

[0065] TICL size replacement recommendations: If the current actual arch height is too low, it is recommended to replace it with a larger standard ICL size; if the current actual arch height is too high, it is recommended to replace it with a smaller standard ICL size; if the current ICL is already the largest or smallest standard size and cannot be adjusted as needed, a corresponding prompt will be given.

[0066] Non-TICL adjustment suggestions

[0067] If the user selects a standard ICL and the evaluation result suggests adjustment, this module will provide two adjustment options.

[0068] Option 1: Rotate ICL (preferred)

[0069] Rotate the current ICL according to the recommended rotation angle to make its adjusted clinical arch as close as possible to the clinical target value;

[0070] Option 2: Change the ICL size (alternative option)

[0071] If rotation does not achieve the desired effect, or if the doctor wishes to consider changing the size, it is recommended to change to a standard ICL size that is one size larger or smaller, depending on the difference between the current actual arch height and the target arch height.

[0072] Specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art can make various changes or modifications within the scope of the claims, which do not affect the essence of the present invention. Unless otherwise specified, the embodiments and features described in this application can be arbitrarily combined with each other.

Claims

1. A method for predicting and adjusting the arch height after ICL surgery, characterized in that, The method includes the following steps: Data acquisition steps: Acquire the patient's ocular anatomy data, including the short and long axis diameters of the ciliary sulcus; acquire the current status data of the implanted ICL, including its nominal size and rotation angle within the eye; Geometric modeling and calculation steps: Based on the nominal size of the ICL and the major and minor axis diameters of the ciliary sulcus, a two-dimensional geometric model of the ICL in the elliptical ciliary sulcus is established. According to the rotation angle of the ICL in the eye, the diagonal lengths defined by the four support points of the ICL are calculated on the model, and then the theoretical geometric arch height is calculated. Adjustment scheme generation steps: Based on the calculated theoretical geometric arch height, at least one secondary surgical adjustment scheme is generated to adjust the actual postoperative arch height to the clinically ideal range. The adjustment scheme includes rotating the current ICL to a new angle or replacing it with another ICL of a different size.

2. The method for predicting and adjusting the arch height after ICL surgery according to claim 1, characterized in that, The data acquisition steps specifically include: The short axis diameter of the ciliary sulcus refers to the diameter of the patient's ciliary sulcus in the horizontal direction; The long axis diameter of the ciliary sulcus refers to the diameter of the patient's ciliary sulcus in the vertical direction; The specific parameters of the ICL implanted during the patient's initial surgery include: The nominal size of ICL refers to the size specified by the manufacturer for the currently implanted ICL; ICL arch height refers to the natural arch height formed by the diagonal structure of the ICL when it is not constrained by the intraocular structure. Current ICL central thickness refers to the thickness of the central optical zone of the currently implanted ICL.

3. The method for predicting and adjusting the arch height after ICL surgery according to claim 1, characterized in that, In the geometric modeling and calculation steps, the theoretical clinical arch height is obtained by subtracting the central thickness of the ICL and the distance from the anterior surface of the lens to the ciliary sulcus plane from the theoretical geometric arch height. The effect of the secondary adjustment scheme is quantified by comparing the difference between the theoretical clinical arch height before and after the adjustment.

4. The method for predicting and adjusting the arch height after ICL surgery according to claim 1, characterized in that, The adjustment plan generation steps specifically include: comparing the actual postoperative arch height input by the user with the preset clinical ideal range, providing a preliminary judgment; if the actual postoperative arch height exceeds the ideal range, then providing an intelligent adjustment plan based on the ICL type. For TICL, when the arch height is not ideal, we provide suggestions to replace it with a different size and predict the change in arch height after the replacement; For non-TICL (Integrated Tier Clamping), when the arch height is not ideal, the solution of adjusting by rotating the ICL is given priority. The optimal rotation angle to achieve the target arch height is calculated and recommended, and the change in arch height after rotation is predicted. At the same time, changing the size of the ICL is also provided as an alternative solution, and its effect is predicted.

5. A device for predicting and adjusting the arch height after ICL surgery, characterized in that, The device includes: Data interface module: used to receive the patient's ocular anatomy data, including the short and long axis diameters of the ciliary sulcus; and the current status data of the implanted ICL, including its nominal size and rotation angle within the eye; Modeling and calculation module: It is configured to establish a two-dimensional geometric model of the ICL in the elliptical ciliary sulcus based on the nominal size of the ICL and the major and minor axis diameters of the ciliary sulcus; and calculate the diagonal length defined by the four support points of the ICL on the model according to the rotation angle of the ICL in the eye, and then calculate the theoretical geometric arch height. Adjustment scheme generation module: configured to generate at least one secondary surgical adjustment scheme based on the calculated theoretical geometric arch height, which aims to adjust the actual postoperative arch height to the clinically ideal range, the adjustment scheme including rotating the current ICL to a new angle or replacing it with another ICL of a different size.

6. The ICL postoperative arch height prediction and adjustment device according to claim 5, characterized in that, The adjustment plan includes: if the current actual arch height is too low, it is recommended to replace it with a larger standard ICL size; if the current actual arch height is too high, it is recommended to replace it with a smaller standard ICL size.

7. The ICL postoperative arch height prediction and adjustment device according to claim 5, characterized in that, The adjustment plan includes: Rotate the ICL according to the recommended rotation angle to make its adjusted clinical arch as close as possible to the clinical target value. If the rotation does not achieve the desired effect, or if the doctor wishes to consider changing the size, it is recommended to change to a standard ICL size that is one size larger or smaller, depending on the difference between the current actual arch height and the target arch height.

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