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WO1991016865A1 - Modification ajustable du profil de lenticules synthetiques - Google Patents

Modification ajustable du profil de lenticules synthetiques Download PDF

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Publication number
WO1991016865A1
WO1991016865A1 PCT/US1991/002978 US9102978W WO9116865A1 WO 1991016865 A1 WO1991016865 A1 WO 1991016865A1 US 9102978 W US9102978 W US 9102978W WO 9116865 A1 WO9116865 A1 WO 9116865A1
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WO
WIPO (PCT)
Prior art keywords
lenticule
cornea
synthetic
over
laser
Prior art date
Application number
PCT/US1991/002978
Other languages
English (en)
Inventor
Keith P. Thompson
Yung Sheng Liu
Seth Richard Banks
Raymond P. Gailitis
Original Assignee
Thompson Keith P
Yung Sheng Liu
Seth Richard Banks
Gailitis Raymond P
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Thompson Keith P, Yung Sheng Liu, Seth Richard Banks, Gailitis Raymond P filed Critical Thompson Keith P
Publication of WO1991016865A1 publication Critical patent/WO1991016865A1/fr

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Classifications

    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/145—Corneal inlays, onlays, or lenses for refractive correction
    • 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
    • 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
    • A61F9/00812—Inlays; Onlays; Intraocular lenses [IOL]
    • 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

  • Ophthalmologists have derived a number of surgical procedures which attempt to correct refractive errors. None of these techniques have gained widespread acceptance because the procedures generally have unpredictable outcomes and undesirable side effects such as glare, fluctuating vision, and corneal scarring. Unpredictable refractive outcome is the primary reason radial eratotomy has not been accepted by a majority of ophthalmologists as an effective treatment for myopia. Two other recent techniques to correct ametropias are briefly described below.
  • Epi eratophakia meaning lens on top of the cornea
  • Epi eratophakia is a technique in which a portion of a donor cornea is used to make a lens which is sewn or glued to the surface of the patient's cornea in an attempt to correct his refractive error.
  • This procedure involves freezing the donor corneal tissue and grinding the posterior surface to achieve the desired optical configuration.
  • This donor lenticule is then usually sewn into a groove in the patient's cornea cut by a circular mechanical trephine with hand dissection of a circular pocket.
  • Epikeratophakia is used primarily in patients who have had cataract operations and in whom an intraocular lens is contraindicated, such as children or older patients with certain eye diseases, and has also been used to correct for myopia.
  • epikeratophakia which render its routine use for patients with refractive errors unsatisfactory. The procedure is highly unpredictable- and errors in refraction exceeding thirty percent of the expected change are common. Decrease in the patient's best corrected visual acuity is also encountered following epikeratophakia.
  • the refractive change achieved by epikeratophakia is not adjustable, and patients who are grossly over or under corrected must have the lenticule removed and replaced.
  • a second technique to correct refractive errors termed photorefractive keratectomy, has recently been developed.
  • Energy generated by a pulsed argon fluoride excimer laser at a wavelength of 193 nm causes a precise removal of corneal tissue without adjacent thermal or mechanical damage.
  • Several optical laser delivery systems have been described which attempt to achieve a controlled etching of the anterior cornea to the desired refractive curvature.
  • This technique clinically unacceptable for some patients: scarring, unpredictable outcome, and refractive instability. Sin ⁇ e this procedure is performed directly in the visual axis, any scarring is unacceptable.
  • the net affect of this redistribution will cause the ablated cornea to shift in an anterior direction following photorefractive keratectomy, inducing a steepening of the optical zone.
  • the extent of this shift will vary with the intraocular pressure, the patient's age, and tissue characteristics and therefore can cause significant variations in optical outcome.
  • the majority of the thickness of the cornea is termed the stro a and consists of water, collagen fibers, a matrix substance, and numerous cells called keratocytes.
  • the keratocytes which reside between Bowman's layer and Desce et's membrane, help produce and maintain the collagen structure of the corneal stroma. These cells are also responsible for wound healing following corneal injury. When Bowman's layer is violated, these cells produce new collagen as scar tissue and attempt to reform the injured or disrupted fibers. The cornea heals in a very slow fashion with the keratocytes laying down and remodeling new collagen over many months to years.
  • Another object of the present invention is to provide a process for application of a synthetic lenticule which does not require ablation of the central corneal region or Bowman's layer, thereby avoiding irreversible disturbance of the visual axis of the patient.
  • a further object of the present invention is to provide an apparatus and a process in which the synthetic lenticule can be safely and easily removed and replaced with a different synthetic lenticule if necessitated by the physical condition of the patient or by other factors.
  • a still further object of the present invention is to provide a process "which corrects refractive errors in patients and which avoids the previously mentioned problems associated with current techniques and procedures.
  • the present invention relates to an apparatus and a process for application and reprofiling, if necessary, a synthetic lenticule for vision correction.
  • the process first involves the removal of the overlying epithelium.
  • a synthetic lenticule which has been formed or selected to correct the particular refractive error in the patient's vision, is then secured over the undisturbed central corneal region utilizing the present apparatus.
  • the application of the lenticule may be carried out under vacuum conditions and certain pharmacological agents may then be applied to the surface of the lenticule to enhance the regrowth of the normal epithelial cells over the lenticule.
  • a further step includes selective reprofiling of the lenticule by laser ablation for refining the refractive power of the lenticule, if necessary.
  • Figure 1 is a partial, side elevational and cross- sectional view of the outer half of a normal human eye.
  • Figure 2 is an enlarged; partial cross-sectional view of the outer half of the eye, shown prior to the operation embodying the present process;
  • Figure 3 is an enlarged, partial cross-sectional view, similar to the preceding figure, . with the epithelium removed, exposing the tenterior surface layer of the cornea;
  • Figure 4 is an enlarged, partial cross-sectional view, similar to the preceding figure, shown with an outer peripheral groove formed in the cornea;
  • Figure 5 is a diagrammatical view of a laser apparatus suitable for ablating the peripheral groove or slit and for reprofiling the lenticule.
  • Figure 6 is a partial top plan view of the eye, corresponding to the view shown in Figure 4 ;
  • Figure 7 is an enlarged, partial, cross-sectional view showing a sealant means disposed in the groove for receiving the edge of the lenticule, the view being taken
  • Figure 8 is a diagrammatical view, shown partially in cross-section, of the apparatus used for placing the lenticule over the cornea;
  • Figure 9 is an enlarged, partial, cross-sectional view, similar to Figure 4, showing the lenticule secured in place over the cornea;
  • Figure 10 is an enlarged, partial, cross-sectional view, similar to the preceding figure, schematically illustrating reprofiling of the lenticule
  • Figure 11 is an enlarged, partial cross-sectional view, similar to the preceding figure, showing the reprofiled lenticule in place with the epithelium regrown thereover;
  • Figure 12 is an enlarged partial, cross-sectional view illustrating an alternate embodiment of the present invention in which no host bed preparation is done to the cornea;
  • Figure 13 is an enlarged, partial, cross-sectional view illustrating another embodiment in which a peripheral slit is formed in the cornea to receive the lenticule; and
  • Figure 14 is an enlarged, partial, cross-sectional view illustrating an alternate embodiment of the embodiment shown in the preceding figure.
  • numeral 20 designates generally the outer half of the human eye upon which the present process for vision correction is performed, portions thereof being described hereinbelow as an aid in understanding the present process.
  • the portions of the cornea 21 of the eye which are involved in the present process include an outer layer of epithelial cells 22 which cover the outer cornea, which is known as Bowman's layer
  • the cornea has an inner corneal membrane 26, known as
  • Descement's membrane which has covering layer 28 on its posterior surface, termed the endothelium. Between the anterior and posterior boundaries are layers of striated tissue, termed the stroma 30, which comprise the bulk of the cornea 21.
  • the optical axis of the eye can be considered as an imaginary line which extends through the central region, including the cornea 21, the lens 34, and the vitreous region 36 to the rear of the eyeball near the optic nerve (shown above) .
  • This region of the cornea is the most important region of the cornea with regard to the vision of the patient. This factor, which has been observed in the outcomes of several of the prior art techniques previously described, is a majox- reason why the present process specifically avoids any surgical invasion of the central region of the cornea.
  • FIG 2 illustrates in magnified detail the section of the eye shown in Figure 1, shown prior to beginning the process embodying the present invention.
  • a detailed analytical profile of the patient's cornea is normally made and analyzed by the physician.
  • Such a profile may be obtained with a conventional kerjatoscope or by a corneal topographic mapping system such as, for example, the Corneal Modeling System developed by the Computed Anatomy Corp. of New York, New York.
  • Such computer modeling provides the physician with a three dimensional profile of the cornea and precisely defines its anterior shape.
  • Corneal topographic data may be used to determine the posterior shape of the lenticule, and refractive data is used to determine the anterior shape.
  • the lenticule can then be manufactured to meet individual patient specifications.
  • the lenticule is manufactured from a synthetic or reconstituted polymer, such as a preferred synthetic collagenous polymer, or other suitable synthetic material that is biocompatible with the tissues of the eye.
  • the lenticule is prepared and treated with appropriate chemical means to achieve the desired properties of constituency, optical clarity, and stability.
  • the material also has characteristics such that it is resistant to invasion and/or degradation by cells and cellular agents.
  • the material can be shaped to the desired specifications by injection molding, lathe cutting, laser profiling, or a combination of these and/or other techniques.
  • the material used for the lenticule has the capability to support and maintain epithelial growth in a normal fashion over its anterior surface and has favorable optical characteristics for the transmission of light in the visible spectrum.
  • a final requirement of the synthetic, material is that it will allow laser ' reprofiling of its anterior surface after attachment to the cornea, which is a significant and unique step disclosed by the present inventive process.
  • Such materials meeting the above requirement are currently available on the market and other suitable synthetic materials are likely to be developed. It is important to note however, that the present process does not involve or contemplate the use of donor corneal material from a human eye.
  • the posterior surface 38 of the lenticule 40 ( Figure 8) is configured such that it precisely matches the patient's anterior corneal curvature after the removal of the epithelium 22.
  • the anterior surface 42 of the lenticule which serves as the new optical curve for the cor ⁇ tea, is shaped prior to application to the curvature necessary to correct the patient's refractive error, when using a lenticule that is relatively rigid.
  • the physician determines in a more general manner the approximate contour of the anterior surface of the cornea to provide an indication of the refractive error to be corrected and to provide a general indication of the required thickness of the lenticule to be applied thereover.
  • This type of general determination is made possible since attachment of the lenticule according to the present method avoids any surgical invasion of the cornea in the visual axis and, as disclosed hereinafter, some attachment techniques avoid any surgical invasion of the cornea whatsoever.
  • the material used for the lenticule in this alternate embodiment has the characteristics defined hereinabove, i.e., capability of being reprofiled, resistant to invasion by cells and cellular agents, and constructed of a material designed to correct refractive errors.
  • the material also has sufficient flexibility to conform to the anterior surface of the cornea. This also obviates the need to profile the posterior surface of the lenticule to conform to the anterior surface of the cornea since the material is self- conforming. Attaching this flexible material to the cornea is accomplished with any of the techniques disclosed herein.
  • FIGs 3 through 14 illustrate the additional steps of the present invention.
  • the corneal epithelium 22 is normally removed mechanically, as shown in Figure 3, with a chemical solution on a swab or by other suitable means.
  • Figure 5 illustrates diagra matically a combination scanning device for mapping the contour of the eye and laser delivery system 44, a preferred system providing energy generated by a pulsed laser for reprofiling the lenticule after its application.
  • One suitable laser system is an argon fluoride excimer laser, the energy produced having a wavelength of 193nm.
  • the system is capable of a precisely determined removal of material without thermal or mechanical damage to adjacent regions. Such a system is discussed in U.S. Patent No. 4,665,913 to L'Esperance, Jr. for a Method For Ophthal ological Surgery.
  • Other suitable laser delivery systems may also be used, such as a 2.9 micron infrared laser system, and other systems are under development.
  • the patient's eye is fixed at the limbus 46, to the housing 48 of the system, by a limbal suction ring 50, a vacuum within the ring being created by evacuating the air within the ring through ports 51, Taking into consideration the diameter and the configuration of the peripheral edge 52 of the prepared lenticule 40, the laser delivery system is programmed to etch a shallow peripheral groove 54, extending into or through Bowman's layer 24 and into the stroma 30.
  • a template (not shown) or a specialized lens, such as an axicon lens (not shown) may be used to direct and focus the microprocessor controlled laser output, forming the groove in a peripheral, optically insignificant region jof the cornea.
  • the groove is formed well outside the visual axis of the patient.
  • mechanical cutting means such as a trephine, may be used to form the groove provided the mechanical means used includes the required precision to form the groove without damage to adjacent tissue under the control of a skilled surgeon.
  • a suitable adhesive means 56 is applied therein to receive and bond the lenticule to the cornea, as shown in Figure 7.
  • a preferred adhesive is collagen-based glue so as to b ⁇ biocompatible with the corneal stroma and with the lenticule.
  • Other suitable securing means may also be used, for example, suturing, with a suitably prepared lenticule, preferably having preformed apertures to receive the sutures, thus preventing asymmetrical tension on the eye or lenticule.
  • Figure 8 diagrammatically illustrates a lenticule application apparatus 58, which may be used in some cases. In the alternative, the lenticule can be placed manually by the surgeon.
  • the eye is fixed as shown in Figure 5, like elements being defined by like numerals, with suction ring 50 securing the apparatus to the limbus 46 of the eye.
  • the apparatus is similar in use to that shown in Figure 5 as far as attachment to the eye; however, certain features have been added as described hereinbelow.
  • the lenticule 40 is held by a suction ring 60 having a vacuum line 61, the ring 60 being attached to a micromanipulator system.
  • the vacuum line communicates with the posterior surface of the suction ring so as to selectively create a vacuum between the ring and the lenticule.
  • the micromanipulator has a horizontal carriage 62, a vertical carriage 64, and a 360° gimbal 66, thus -being capable of movement in any axis as well as translations across these axes.
  • the unit is powered through electrical power lines or cables 67 and is driven by a motor 65 which receives signals from a microprocessor 68.
  • Th ⁇ micromanipulator unit is controlled by the surgeon with conventional remote control means (not shown) .
  • the main chamber 69 is evacuated of air through suction ports 70. With a sufficient vacuum obtained, the lenticule 40 is lowered into position on the cornea.
  • the surgeon may utilize fiber optic viewing ports 72 to assist in alignment of the peripheral edge 52 of the lenticule with the groove 54.
  • the vacuum in the main chamber is released. Since the mating of the lenticule with the corneal surface occurs under conditions of low pressure, the return of ambient air pressure causes a firm seating of the lenticule to the cornea. This assures good approximation of the posterior surface of the lenticule to the corneal layer during the bonding period of the glue which normally takes several minutes. The glue achieves permanent bonding of the peripheral edge of the lenticule in the groove.
  • the precision etching of the groove by the laser assures that the anterior surface of the edge portion is substantially flush with the outer, adjacent corneal layer, thus providing no mechanical barrier to the epithelial cell layer which then regrows over the lenticule.
  • the anterior curvatures can be remeasured to determine if the anticipated correction has been achieved. If there were inaccuracies in the initial calculation of the lenticular shape or ' changes in lenticule curvature due to the attachment technique, these may be immediately corrected by laser reprofiling of the lenticule by the laser delivery system.
  • certain pharmacological agents may be applied which enhance and speed the growth of epithelial cells over the lenticule, agents such as fibronectin, epidermal growth factor, and antibiotics. With these agents, epithelial covering will normally be complete within several days, this being illustrated in Figure 11.
  • a suitable laser delivery system as previously described and shown in Figure 5, can be used to reprofile the anterior curvature of the lenticule to the desired shape.
  • the data used to determine reprofiling criteria are determined in follow-up examinations and may include the previous data obtained on the patient, corneal topographic mapping, automated cycloplegic refraction measurements, and any other pertinent data.
  • the corneal epithelium is removed as previously described, the eye then being as shown in Figure 9.
  • the laser delivery system shown in Figure 5 is set up and the eye is fixed at the limbus 46 as discussed hereinabove. Assuming, for example, that a myopic condition still exists or develops later, the laser is directed to reprofile the surface of the lenticule 40 in the central region thereof, thereby reducing the curvature, this being schematically illustrated in Figure 10. To increase the curvature, the laser ablation would be directed to the peripheral regions of the lenticule (not shown) , thus steepening the curve and adjusting for hyperopic condition.
  • the epithelium regrows over the lenticule, as shown in Figure 11.
  • the lenticule's design allows for laser reprofiling of its anterior surface after attachment to the patient's eye.
  • Such reprofiling allows .cprrection of residual refractive errors.
  • the process thus provides patients with refractive errors an alternative means of correcting their vision without the need for spectacles, contact lenses, or current surgical techniques, and allows for future corrections to be made as needed.
  • Another safety advantage to the synthetic, overlay technique is the avoidance of direct irradiation of the optical axis of the eye with far ultraviolet laser energy.
  • the refractive result remains stable over time. Since the overlay is composed of a material whi.ch prevents i.nvasion or degradation by cells or cellular agents, no refractive shift caused by collagen deposition or removal is encountered as is seen in photorefractive keratectomy.
  • a further, significantly unique feature of the synthetic overlay process described herein is the ability to adjust the refractive power of the lenticule after it is placed on the cornea. Unlike procedures such as radial keratotomy or epikeratophakia which are not adjustable, the overlay can be reprofiled while in place on the corneal surface if a new refractive power is needed. Although photorefractive keratectomy procedures could be repeated on patients who did not achieve their desired correction, each treatment would irreversibly remove more of the patient's central corneal tissue, and risk causing corneal scarring with every treatment.
  • FIG. 12 an alternate embodiment of the present invention, with regard to the application of the lenticule, is illustrated in cross-section.
  • the lenticule 140 is applied directly over Bowman's layer 24 with no disturbance at all to Bowman's layer or the stroma 30.
  • the peripheral edge 152 of the lenticule is chamfered so as to provide a smooth transition between the lenticule edge and Bowman's layer, thus presenting no obstacle to the regrowth of the epithelial cell layer.
  • the lenticule is secured in place with a suitable biocompatible adhesive means 56, which is applied either beneath the peripheral edge 152, as shown in Figure 12, or where the adhesive is substantially completely transparent, beneath the entire lenticule, as shown in Figure 13 for the succeeding embodiment, or by other suitable means.
  • a suitable biocompatible adhesive means 56 which is applied either beneath the peripheral edge 152, as shown in Figure 12, or where the adhesive is substantially completely transparent, beneath the entire lenticule, as shown in Figure 13 for the succeeding embodiment, or by other suitable means.
  • This embodiment offers advantages in that no receiving means, i.e. a peripheral groove, etc. is formed in the cornea, thus making the procedure completely reversible.
  • FIGS. 13 and 14 illustrate another embodiment of the present invention, the application differing only in the use and/or non-use and placement of the securing means, as between the two figures.
  • a peripheral slit 180 is formed in an optically insignificant region of the cornea, the slit being formed by any of a number of conventional means, such as a trephine.
  • the chamfered edge 252 of lenticule 240 is inserted into the slit 180 where it is retained by means of the design of the chamfered edge portion and the angle at which the slit 180 is formed without the need for an adhesive or other securing means.
  • the lenticule 240 may also be further secured by the application of an adhesive means 56 either beneath the entire lenticule, as shown in Figure 13, or at the peripheral edge, as shown in Figure 14.
  • lenticule 240 is designed with the same principles in mind as the previously described embodiments, providing the capability of profiling or reprofiling the lenticule with the laser after its application over the cornea, providing for reversibility of the operation with no disturbance of the central corneal region, and providing a smooth transition between the peripheral edge thereof and Bowman's layer, thus facilitating the regrowth of the epithelial layer.
  • the lenticule may be relatively rigid or flexible and thus, self-conforming.
  • a further possible material for the lenticule is a viscous material which could be spread in place over a patient's cornea.
  • a suitable molding device is placed over the viscous mass to generally form the shape of the lenticule.
  • the viscous lenticule material is then solidified, using UV cross-linked collagen molding. Once solidified the material is stable and can be profiled, reprofiled and/or removed if necessary or desirable.
  • a collagenous adhesive means may be used to secure the lenticule in place over the cornea, utilizing a similar system of cross-linking via ultraviolet radiation.
  • the synthetic lenticule may be removed if unforeseen problems develop.
  • a malfunction in the laser r-eprofiling delivery system when used as described above may render the synthetic lenticule optically unacceptable, but would leave the patient's central cornea completely intact, and a substitute lenticule can easily be applied.
  • This ease of removal also permits the profiling or reprofiling steps discussed hereinabovei f to be easily accomplished with the lenticule having been removed from over the cornea.
  • a lenticule having the peripheral edge disposed in a slit with no use of securing means can easily be removed for reprofiling if necessary, the determination of what adjustments are needed being made by the ophthalmologist, perhaps with the aid of a computer. While an embodiment of an apparatus and process for application and adjustable reprofiling of synthetic lenticules for vision correction and modifications thereof have been shown and described in detail herein, various additional modifications may be made without departing from the scope of the present invention.

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Abstract

Appareil et procédé permettant d'appliquer une lenticule synthétique sur la cornée d'un ÷il humain ledit procédé concernant également la modification sélective du profil de la lenticule lorsque celle-ci se trouve déjà placée sur la cornée. Le procédé comprend la pose de la lenticule (140) sur la cornée (24) à l'aide d'un adhésif (56), ceci ne perturbant pas l'axe optique de l'÷il, ou bien à l'aide d'un bord périphérique (152) de la lenticule qui se trouve retenu par une fente située sur le pourtour. S'il est nécessaire de modifier le profil de la lenticule afin qu'elle ait un meilleur pouvoir de réfraction, on utilise pour ce faire, un système émeltant un faisceau laser.
PCT/US1991/002978 1990-05-02 1991-05-01 Modification ajustable du profil de lenticules synthetiques WO1991016865A1 (fr)

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US51737890A 1990-05-02 1990-05-02
US517,378 1990-05-02

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003101348A1 (fr) * 2002-05-31 2003-12-11 Bausch & Lomb Incorporated Materiaux polymeres utilises comme lenticules intra-corneens photoablatifs
WO2006112952A3 (fr) * 2005-04-15 2007-12-21 Minu Llc Lentille intraoculaire adaptee pour etre reglee par laser apres implantation
US9545303B2 (en) 2011-12-02 2017-01-17 Acufocus, Inc. Ocular mask having selective spectral transmission
US9204962B2 (en) 2013-03-13 2015-12-08 Acufocus, Inc. In situ adjustable optical mask
US9603704B2 (en) 2013-03-13 2017-03-28 Acufocus, Inc. In situ adjustable optical mask
US10350058B2 (en) 2013-03-13 2019-07-16 Acufocus, Inc. In situ adjustable optical mask
US10939995B2 (en) 2013-03-13 2021-03-09 Acufocus, Inc. In situ adjustable optical mask
US11771552B2 (en) 2013-03-13 2023-10-03 Acufocus, Inc. In situ adjustable optical mask
US9427922B2 (en) 2013-03-14 2016-08-30 Acufocus, Inc. Process for manufacturing an intraocular lens with an embedded mask

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