USRE47550E1 - Device, method, and control program for refractive surgery - Google Patents

Device, method, and control program for refractive surgery Download PDF

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Publication number
USRE47550E1
USRE47550E1 US15/887,767 US200815887767A USRE47550E US RE47550 E1 USRE47550 E1 US RE47550E1 US 200815887767 A US200815887767 A US 200815887767A US RE47550 E USRE47550 E US RE47550E
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pupil
apex
eye
property
control program
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Sissimos Lemonis
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Alcon Inc
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Wavelight GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/11—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring interpupillary distance or diameter of pupils
    • A61B3/112—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring interpupillary distance or diameter of pupils for measuring diameter of pupils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/113—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for determining or recording eye movement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F9/00802—Methods or devices for eye surgery using laser for photoablation
    • A61F9/00804—Refractive treatments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F9/00825—Methods or devices for eye surgery using laser for photodisruption
    • A61F9/00827—Refractive correction, e.g. lenticle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00844—Feedback systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00844—Feedback systems
    • A61F2009/00846—Eyetracking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
    • A61F2009/00872—Cornea

Definitions

  • the invention relates to an apparatus for refractive surgery, to a control program for such an apparatus, and to a method for generating such a control program.
  • Refractive surgery is understood by specialist circles as the alteration of the imaging properties of the optical system “eye” through laser radiation.
  • the laser radiation thus alters the refractive properties of one or more components of the eye. Since it is mainly the cornea that determines the imaging property of the eye, refractive surgery is used, in particular, to perform shaping of the cornea.
  • a prominent example of such reshaping of the cornea for the purpose of altering its refractive properties is that of LASIK.
  • the present invention relates, in particular, to the LASIK technique.
  • the invention is also generally applicable in PRK and EPI-LASIK.
  • the invention can also be applied in the case of use of femtosecond lasers.
  • a so-termed ablation profile is determined, i.e. it is calculated, on the basis of measurements on the eye and, if appropriate, other influencing variables, how much tissue (stroma) is to be removed at which location of the cornea, in order that, following the removal, the cornea has an optimum shape for the eye to be treated, i.e. the previously existing optical imaging defects of the eye are, as far as possible, corrected.
  • tissue stroma
  • Various methods are known in the prior art for the said calculation of the ablation profile.
  • the ablation profile has been determined for the eye that is to be treated, it is then calculated how this profile can best be removed (ablated) from the cornea by means of laser radiation. For this purpose, there is calculated a sequence of individual laser pulses, in space and time, which, in interaction with the stroma, effects the required reshaping of the cornea.
  • the ablation profile is a three-dimensional shape, and corresponds to a volume of the cornea that is to be removed.
  • the computer controls the laser radiation, for example individual laser pulses (“spots”), over the eye in a space and time sequence in accordance with a control program.
  • spots individual laser pulses
  • the ablation centre is the spatial reference point to which the said spatial sequence of laser pulses relates.
  • the mid-point (the centre) of the pupil is usually used as the ablation centre.
  • the pupil i.e. the opening left open by the iris, as a diaphragm, for the passage of radiation into the eye, has a relatively sharp contour, and therefore it is suitable for recording by means of a camera and analysed by means of image processing programs.
  • Such recording devices and processing programs are well known as such in the prior art, and the present invention can have recourse thereto to some extent.
  • the eye to be treated is not of a constant size, but rather properties and also the orientation of the eye can change during the procedure. Changes in the orientation of the eye are tracked, according to the prior art, by means of a so-termed eye tracker.
  • An eye tracker traces movements of the eye, usually through the aforementioned recording of the pupil by means of a camera and with subsequent image processing. Movements of the eye are also executed concomitantly by the pupil, and therefore the movements can be determined in this manner, and the control of the laser beam can be matched to such eye movements, i.e. the previously calculated ablation profile is removed with precision, despite eye movements during the operation, which, as a rule, cannot be precluded in a reliable manner.
  • the prior art as a rule uses the centre of the pupil as the ablation centre.
  • the intention of the present invention is to improve this prior art, and in this proceeds from the following considerations:
  • the pupil likewise, does not have a constant size and shape.
  • the pupil also does not have a perfect circular shape, but rather it generally has dimensions that are longer in one direction than in another direction.
  • the dimensions of the pupil depend, as is known, on the quantity of incident light, and the eye adapts the cross-section of the pupil as a function of the quantity of incident light.
  • change in the size of the pupil also involves a change in the displacement of the pupil centre.
  • the pupil centre shifts in this case (in the case of a non-circular form, the pupil centre can be understood to be, for example, the centroid of the area).
  • the conditions are rendered yet more complex by the fact that, as a general rule, a change in area of the pupil is also accompanied by a rotation of the non-circular pupil form, this being known in physiology as cyclotorsion.
  • the pupil centre does not lie exactly on the optical axis of the eye.
  • differing axes are defined, the optical axis and the visual axis being of particular importance for the present invention.
  • the optical axis joins the centres of curvature of the refractive surfaces of the eye components, i.e. as a rule, it is perpendicular to all refractive surfaces.
  • the visual axis is usually the line that joins the point fixed by the eye and the fovea. As a rule, this line goes through the so-termed nodal point on the rear surface of the lens, doing so at a location at which, as a rule, the optical axis also passes through this point.
  • the optical axis does not go through the fovea.
  • the angle between the optical axis and the visual axis is typically in the region of 5°.
  • the invention proceeds from the knowledge that improved refractive-surgery results can be achieved if neither a centre of the pupil nor a point on the optical axis is used as a reference point for ablation, i.e. as a so-termed ablation centre. If the pupil centre is used as the ablation centre, even the above-mentioned displacement of the pupil centre alone, in dependence on the pupil size, regularly results in a systematic error, and it is only by chance, in the case of particular advantageous properties of the eye that happens to be treated, that centring of the ablation on the pupil centre can lead to good ablation results.
  • the eye is measured by means of a wave-front analysis, for example according to Hartmann-Shack or Tscherning, or through topography measurements.
  • a wave-front analysis for example according to Hartmann-Shack or Tscherning, or through topography measurements.
  • so-termed “standard” ablations likewise, it is necessary to determine the ablation profile with high precision.
  • WO 03/011177 A2 teaches the centring of an ablation on the visual axis in relation to the pupil centre.
  • US 2004/019346 A1 describes a method for ablation on the cornea, wherein the laser radiation is controlled according to the angles between the corneal surface and the laser beam. The respective local angle of incidence of the radiation is used to determine the locally required ablation of the tissue.
  • a thus determined ablation map does not use the apex of the corneal surface for the purpose of aligning the ablation profile to the apex, in particular not using the dependence of the position of the apex on a property of the pupil.
  • the invention is based on the object of specifying, for refractive surgery, an ablation centre that is to be determined with relatively simple means and by which improved refractive results can be achieved.
  • the invention teaches an apparatus for refractive surgery, having the features of claim 1 . Furthermore, the invention teaches a control program for such an apparatus, having the features of claim 5 .
  • the invention is thus based on the knowledge that improved ablation results can be achieved if, during the surgical procedure, the ablation is centred on the apex of the cornea, which apex is located on the front surface of the cornea.
  • the apex is the highest point of the cornea, its summit.
  • the above-mentioned points on the surface of the cornea are not easily determined during the surgical procedure, at least not with the use of known, available means.
  • the invention therefore teaches the empirical determination, for the eye to be treated, of the functional dependence of the spatial position of the above-mentioned point on the cornea surface (which point is to serve as the ablation centre) on the shape and position of the pupil.
  • the pupil is in any case measured by means of a camera and with sufficient frequency, such that movements of the eye are executed concomitantly by the laser-beam guidance system (eye tracker).
  • the controlling computer can then relate the laser beam, i.e. the ablation profile, to the apex as a reference point (ablation centre).
  • the pupil, or the iris be measured during the refractive procedure, which, as stated, is effected for other reasons in any case.
  • Suitable pupil properties to be measured which represent the said functional relationship between the selected ablation centre on the cornea and quantities that can be measured during the operation, are, in particular, certain dimensions of the pupil and its shape resulting therefrom.
  • this functional dependence between the ablation centre and measurement quantities also takes account of properties of the iris.
  • the iris usually rotates upon alteration of the pupil size, and this rotation can be identified in that certain structures of the iris rotate, this being identifiable through image processing of the image recorded by means of the camera.
  • the said functional dependence between the position, e.g. the apex, and properties of the pupil and/or the iris can be stored, for example, in the manner of a memory table in the computer.
  • the measurement of the functional dependence of the position of the apex (or of another selected ablation centre according to the invention) on measurement data of the pupil, such as, in particular, its size and shape, can be so effected, for example, that (before the refractive surgery, as understood) the apex is determined with the use of appropriate means, for example a topometer, in the case of the eye to be treated.
  • This position of the apex can then be fixed by means of markings on the cornea, which markings preferably are not located directly on the apex.
  • so-termed keratometer marks can be projected close to the apex, which marks define the spatial position of the apex, i.e. the image-processing computer identifies the position of the apex from the markings.
  • the said functional relationship between the properties of the pupil/iris and the apex position is then determined (again, before the actual surgical procedure).
  • the invention also provides, for example on a data medium, a control program for an apparatus for refractive surgery that comprises the following:
  • the invention also relates to a method for generating a control program for refractive surgery, by means of which method laser radiation is directed onto or into an eye to be treated, according to a predefined spatial and time sequence, the predefined spatial and time sequence being aligned in relation to a site of the eye, and
  • the aforementioned site of the eye is, in particular, the above-mentioned ablation centre, the apex of the cornea or a point having a fixed distance from the apex.
  • the above-mentioned parameters relating to the pupil properties can also be used in the case of the method, according to the invention, for generating the control program.
  • FIG. 1 shows, schematically, a section through an eye, with the axes and points of intersection that are of particular interest in this case;
  • FIG. 2 shows, schematically, an apparatus for refractive surgery.
  • the saggital section through an eye 10 shows, schematically, a cornea 12 , a lens 14 , an anterior chamber 16 , an iris 18 , the edge 18 a of which is bounded by a pupil 20 , a fovea 22 , a macula lutea 24 , an optical axis 26 and a visual axis 28 .
  • the optical axis 26 intersects the front surface 12 a of the cornea 12 at the location O.
  • the visual axis 28 intersects the front surface 12 a of the cornea at the location V.
  • the apex A of the cornea 12 is located neither at the location O nor at the location V, such that the point of intersection V of the visual axis is located between the apex A and the point of intersection O of the optical axis with the corneal surface.
  • V is located closer to A than to O.
  • FIG. 2 shows, schematically, an apparatus for refractive surgery, comprising a laser-beam source 34 , which emits a laser beam 32 that, by means of devices 36 for beam shaping and guidance, is directed onto an eye 10 to be treated.
  • a camera for example an IR camera 38 , is used to record, in particular, the pupil and the iris of the eye, and the digital image signal is input to a computer 40 .
  • the computer 40 controls all the components mentioned, thus, in particular, the laser-beam source 34 and the means 36 for beam shaping and guidance.
  • the components described thus far are well known as such in the prior art, and are not explained more fully here.
  • the ablation profile is first determined, in a manner known per se, for an eye to be treated. This is effected through measurement of the eye, e.g. through wave-front analysis.
  • the thus obtained ablation profile is stored in the computer 40 .
  • the computer 40 furthermore includes a control program for the purpose of controlling, in particular, the devices 36 for beam shaping and guidance in accordance with the ablation profile. This is likewise well known as such in the prior art.
  • the apex A of the cornea of the eye to be treated is determined, i.e. the spatial coordinates of the apex point A are measured. This can be performed, for example, by means of so-termed keratometer marks, i.e. one or more markings, which define the position of the apex A, are projected on the surface 12 a of the cornea, close to the apex A. This measurement of the apex can be effected, for example, by means of a conventional topometer. Thereafter, the coordinates of the apex A can be assumed to be constant for the eye, and they serve as a reference point, i.e. as an ablation centre for a subsequently performed ablation, this reference point remaining invariable even in the case of changing pupil widths and, also, pupil rotation.
  • the dependence of the position of the centre on the pupil width is first determined.
  • a widening of the pupil is not concentric, i.e., as a rule, the pupil centre will have shifted following a widening of the pupil.
  • This dependence of the position of the pupil centre on the pupil width is determined in that differing pupil widths are produced in a stepwise manner, and the coordinates of the pupil centre are determined in relation to each pupil width, with the apex as the reference point.
  • the variation of the pupil width is effected by altering the incident visible light, such that naturally occurring widening of the pupil is effected (a pharmacological widening of the pupil frequently differs from its natural movement).
  • An infrared camera is then used to determine the respective position of the pupil centre for the various pupil widths, with the previously determined apex as the reference point.
  • the dependence of the angle of the pupil rotation on the pupil width is determined analogously.
  • the IR cameral in addition to identifying the pupil centre, the IR cameral also identifies the variation of the position of the iris pattern, which provides information concerning the pupil rotation.
  • the image processing programs stored in the computer 40 use the stored functions, described above, relating to the instantaneous pupil size and pupil position to calculate the coordinates of the apex A, and the computer 40 takes this instantaneous apex A, as the ablation centre, as a basis in the control of the devices 36 for beam guidance, i.e.
  • the individual laser pulses are positioned in accordance with the ablation profile in which the instantaneously measured site of the apex A serves as the ablation centre. This is performed repeatedly, at the said high frequency, during the entire refractive surgical procedure, such that the instantaneous ablation centre always corresponds to the actual state of the eye.
  • the “eye tracking”, known per se is performed by means of the camera 38 and the computer 40 during the procedure.
  • the centring of the ablation on the apex A already provides an improved refractive-surgery result, i.e. an improvement of the visual correction.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Optics & Photonics (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Human Computer Interaction (AREA)
  • Electromagnetism (AREA)
  • Otolaryngology (AREA)
  • Laser Surgery Devices (AREA)
  • Eye Examination Apparatus (AREA)
US15/887,767 2007-04-25 2008-04-24 Device, method, and control program for refractive surgery Active 2030-09-25 USRE47550E1 (en)

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Application Number Priority Date Filing Date Title
US15/887,767 USRE47550E1 (en) 2007-04-25 2008-04-24 Device, method, and control program for refractive surgery

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP07008446A EP1985269B1 (de) 2007-04-25 2007-04-25 Vorrichtung, Verfahren und Steuerprogramm für die refraktive Chirurgie
EP07008446 2007-04-25
US15/887,767 USRE47550E1 (en) 2007-04-25 2008-04-24 Device, method, and control program for refractive surgery
PCT/EP2008/003311 WO2008131909A1 (de) 2007-04-25 2008-04-24 Vorrichtung, verfahren und steuerprogramm für die refraktive chirurgie
US12/597,139 US8672925B2 (en) 2007-04-25 2008-04-24 Device, method, and control program for refractive surgery

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EP (1) EP1985269B1 (ru)
JP (1) JP5503529B2 (ru)
KR (1) KR101294327B1 (ru)
CN (1) CN101677875B (ru)
BR (1) BRPI0810131B8 (ru)
CA (1) CA2684880C (ru)
ES (1) ES2368450T3 (ru)
MX (1) MX2009011570A (ru)
RU (1) RU2472477C2 (ru)
WO (1) WO2008131909A1 (ru)

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EP1985269A1 (de) 2008-10-29
US8672925B2 (en) 2014-03-18
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CA2684880C (en) 2013-11-12
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KR101294327B1 (ko) 2013-08-07
EP1985269B1 (de) 2011-07-27
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US20100211054A1 (en) 2010-08-19
CA2684880A1 (en) 2008-11-06
RU2009141582A (ru) 2011-05-27
KR20100020453A (ko) 2010-02-22
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RU2472477C2 (ru) 2013-01-20
ES2368450T3 (es) 2011-11-17

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