JPH0370971B2 - - Google Patents

Description

[Detailed description of the invention] [Industrial application field]

The present invention relates to an ophthalmic surgery aid.

[Prior art and its problems]

Of the ultraviolet rays contained in sunlight, most of the ultraviolet rays with a wavelength of about 280 nm or less are absorbed by the ozone layer in the upper atmosphere, and light with longer wavelengths falls on the earth's surface. Of these lights, in eyes with crystalline lenses, ultraviolet rays with wavelengths of approximately 280 to 320 nm are absorbed by the cornea, near ultraviolet rays with wavelengths of approximately 320 to 400 nm are absorbed by the crystalline lens, and ultraviolet rays with wavelengths of approximately 400 to 780 nm are absorbed by the cornea. visible light and near-infrared light with wavelengths of approximately 780 to 1400 nm reach the retina. Note that infrared rays with wavelengths of about 1400 nm or more are absorbed by the cornea. Therefore, when the crystalline lens is surgically removed due to certain eye disorders or diseases, such as cataracts, approximately
Near ultraviolet rays with a wavelength of 320 to 400 nm can reach the retina, resulting in damage to the retina. For this reason, when undergoing lens removal surgery and wearing an intraocular lens for aphakia, the intraocular lens itself must be constructed so that it absorbs and cuts near ultraviolet rays with a wavelength of about 320 to 400 nm. From this point of view, it has been proposed that intraocular lenses be made of a polymer containing an ultraviolet absorber that absorbs near ultraviolet rays having a wavelength of about 320 to 400 nm. However, it has been pointed out that even when intraocular lenses made of materials containing such ultraviolet absorbers are used, retinal disorders occur. As research into the occurrence of such retinal disorders progressed, it became possible to believe that this was caused by the light from the surgical microscope at the time of intraocular lens implantation. In other words, due to ophthalmic surgical techniques, it is necessary to confirm the posterior capsule using coaxial illumination light, the optical axis of the microscope is close to the optical axis of the surgical eye, and the light with high energy density is used for retrobulbar anesthesia and index imaging due to the condensation of the intraocular lens. We have come to believe that this is due to continuous focusing at the posterior pole of the surgical eye, which is fixed with a thread. In fact, in experiments on monkey eyes and human eyes, it has been confirmed that retinal damage occurs when exposed to microscopic light for 7.5 to 60 minutes. In addition, since the light rays from a surgical microscope are strong, they inevitably cause damage not only to the retina but also to the cornea of the anterior segment of the eye. From this point of view, it has been proposed to place a light-blocking lens-shaped object on the cornea during surgery.

[Disclosure of the invention]

The inventor of the present invention found that the above-mentioned light-shielding lens shape does not allow visualization of the anterior chamber during surgery, and that the strength of the suture can be determined based on the creases in the cornea, especially when suturing the sclerocornea after inserting an intraocular lens. However, this judgment was extremely difficult to make, and this light-shielding lens shape was not sufficient, so as we continued our research and development, we discovered that it did not need to be light-shielding. I've reached it. That is, the present inventor has determined that the main cause of retinal damage is near ultraviolet rays with a wavelength of about 320 to 400 nm in microscopic light, and the retina In addition, in phakic eyes until lens removal during surgery, the crystalline lens acts as a near-ultraviolet filter,
Although it was thought that retinal damage would not occur, it has come to be thought that even phakic eyes may be affected to some extent if it takes a long time during eye surgery in which the eyeball is fixed, and furthermore, it has become clear that retinal damage may occur even in phakic eyes. Because the near-UV filter is missing for a certain period of time until the intraocular lens is inserted, the eye becomes aphakic.
It was discovered that retinal damage may occur if the surgical procedure leading up to the insertion of an intraocular lens is prolonged, and approximately 320 patients were diagnosed during the entire procedure from the start of the surgery to the end of the surgery.
They came to the knowledge that if near-ultraviolet rays of ~400 nm are blocked, retinal damage will not occur. Therefore, even if the lens-shaped object placed on the cornea during intraocular lens implantation surgery is made of a material that blocks near-ultraviolet rays, it is possible to reduce the likelihood of retinal damage. I found it. Even if this lens shape is made of a translucent material, it not only does not cause retinal damage, but also enables visualization of the anterior chamber during surgery. This method had the advantage that the strength of the suture could be judged by the degree of wrinkles produced on the cornea without having to remove the lens-shaped object from above the cornea. In addition, the ophthalmic surgery aids that will be placed on the cornea of the operated eye must be removed after the surgery, and may also need to be moved during the surgery. Therefore, if a protrusion is provided at a position offset from the center of the front surface (opposite the corneal surface) of this ophthalmic surgery aid,
The above operations can be performed extremely easily. The shape of this ophthalmic surgery aid may be, for example, about 6 to 12 mm in diameter, preferably about 9 to 10 mm, and the curvature of the inner surface (corneal surface) side is about 7.2 to 8.6 mm. preferably about 8.2 to 8.3 mm, and the center thickness is about 0.1 to 1.0 mm, preferably about 0.2 to 0.5 mm, and the front curve is almost parallel to the inner curve;
Alternatively, it is preferable to use a concave lens type having a negative power of 0 to -0.3D. In other words, since it is used by placing it on the cornea, this ophthalmic surgery aid may be configured to resemble a contact lens (however,
Although the top view does not have to be circular like a contact lens), in order to avoid converging the microscope light, this ophthalmic surgery aid should be shaped so that the power is zero or negative. This is desirable. In addition, as mentioned above, this ophthalmic surgery aid has the following features:
It must be made of a see-through material that blocks near-ultraviolet rays, but if possible, it is also desirable to have soft properties. In other words, if a so-called hard contact lens is made of a material such as polymethyl methacrylate, the cornea (eyeball) may be significantly deformed when the ophthalmic surgical aid made of such a hard material is removed. Because there was a possibility that it would happen. In addition, in the case of ophthalmic surgical aids made of a so-called water-containing soft contact lens material such as 2-hydroxyethyl acrylate, it is difficult to place them on the cornea by being irradiated with microscopic light during use. The ophthalmic surgery aids that were used tended to dry out, which caused them to become deformed and sometimes fall off the cornea.
It would be desirable to use a material that does not have such drawbacks, that is, a non-water-containing material. Silicone rubbers such as dimethyl silicone or methylphenyl silicone are examples of materials with the above-mentioned properties, but since these silicone rubbers are hydrophobic, they are treated with hydrophilic materials to make the surface hydrophilic. It would have been desirable to undergo sexualization treatment. In addition, such hydrophilic treatment can be carried out, for example, by subjecting an ophthalmic surgical aid made of silicone rubber to a desired shape to low-temperature plasma treatment in an oxygen, nitrogen, or inert gas atmosphere, or by treating it with N −
Examples include performing low-temperature plasma polymerization in an atmosphere of a water-soluble polymer monomer such as vinylpyrrolidone, 2-hydroxyethyl acrylate, or ethylene glycol. And such ophthalmic surgery aids. Silicone rubbers, such as dimethylsiloxane or methylphenylsiloxane, and as ultraviolet and near-UV absorbing materials, e.g. Green No. 201, 202
No., green pigment like No. 402, yellow No. 204, No. 205,
Yellow dye like No. 405, red No. 202, 204, 206
Red pigments such as No. 204, Blue pigments such as No. 403, Blue pigments such as No. 404, Purple pigments such as No. 401, Purple pigments such as No. 401, Brown pigments such as Brown No. 201, Orange pigments such as No. 203
Appropriately select prescribed legal pigments such as orange pigments such as No. 1, No. 204, and No. 401, sufficiently mix and disperse a predetermined amount of these, and after thoroughly degassing, pour this into a mold of a predetermined shape. Either the silicone rubber as described above is injected into a mold of a predetermined shape and cured by heating, and then the silicone rubber is taken out and immersed in a solution in which a legal dye as described above is dissolved. Obtained by interposing a legal dye inside.

【Example】

FIG. 1 is a perspective view of one embodiment of the ophthalmic surgery aid according to the present invention, and FIG. 2 is an explanatory view showing the use of this ophthalmic surgery aid. Dimethylsiloxane and legal dye Red No. 501,
After mixing and dispersing a predetermined amount of Yellow No. 204, Green No. 204, and Orange No. 203 and sufficiently degassing, this is poured into a mold of a predetermined shape, heated to a predetermined temperature and cured, and after curing. This is removed from the mold to obtain an ophthalmic surgery aid 1 as shown in FIG. The curvature of the curve on the inner surface 2 side of this eye surgery aid 1 is 8.25 mm, the thickness at the center is 0.4 mm, the diameter is 9 mm, and it is molded into a concave lens shape with a power of -1.0D. 2mm in diameter and 3 in length on the front 3 side of the periphery, which is further shifted from the center.
It has a configuration in which a shaft 4 of mm is provided. The ophthalmic surgery aid molded into the shape shown in Figure 1 was autoclaved twice at 120°C for 20 minutes to fully harden it and release the residual dye. A low-temperature plasma treatment is performed in an air atmosphere to make the surface of the ophthalmic surgery aid 1 hydrophilic. When the light transmittance of the ophthalmic surgery aid 1 thus obtained was measured using a UV-265FW spectrophotometer manufactured by Shimadzu Corporation, as shown in FIG.
In the wavelength range of 200 to 400 nm, the transmittance is less than 30%,
In the wavelength range of 400 to 500 nm, the transmittance is approximately 40 to 60%,
The transmittance is about 75% or more in the wavelength range of 500 to 800 nm, and this eye surgery aid 1 sufficiently blocks ultraviolet rays, near ultraviolet rays, and some visible light, and is transparent. It was hot. In addition, regarding this ophthalmic surgery aid 1, a safety test (Ministry of Health and Welfare Notification No.
No. 302) was carried out, and all of the dissolution tests for sodium carbonate, citric acid, and water were passed. In addition, no change was observed even after boiling in sterile purified water for about 30 minutes, so this ophthalmic surgery aid 1 can be sterilized by extremely simple means. Then, as shown in FIG. 2, the ophthalmic surgery aid 1 as described above is placed on the cornea 11 of the operated eye,
Then, the intraocular lens implantation surgery was performed using a Zeiss 6C type microscope under the normally used illumination range as the light source 12. During this surgery, it was possible to see through the anterior chamber, and changes in the anterior chamber could be easily confirmed. Moreover, it was stable on the cornea and did not interfere with surgical operations, and furthermore, no corneal or retinal disorders were observed. Example 2 A predetermined amount of dimethylphenylsiloxane is injected into a mold of a predetermined shape, heated and hardened, and then taken out to obtain an undyed ophthalmic surgical aid having the shape shown in FIG. After that, this is legally dyed red No. 501 and yellow No. 204.
No. 202 and Green No. 202 are immersed in an ethanol solution for about 40 minutes for dyeing. Then, after washing and removing the dye attached to the surface, autoclave treatment is performed twice for 20 minutes at 121° C., and finally low-temperature plasma treatment is performed in an air atmosphere to obtain an ophthalmic surgery aid. The curvature of the inner surface of this eye surgery aid is 8.30 mm, the thickness of the center is 0.4 mm, and the diameter is 9 mm.
It has a concave lens shape with a power of -0.5D, and a shaft with a diameter of 2 m and a length of 3 mm is provided at a position on the front side of the peripheral part offset from the center. Then, we determined the light transmittance of this ophthalmic surgery aid.
When measured with a UV-265FW spectrophotometer, it is 200~
Transmittance is less than 10% in the 400nm wavelength region, 400~
In the wavelength range of 500nm, the transmittance is 15~25%, 500~
In the wavelength range of 800nm, the transmittance is 60-70%,
This aid for ophthalmologic surgery sufficiently blocks ultraviolet rays, near ultraviolet rays, and some visible rays, and is transparent. In addition, it has passed the stability test of the Ministry of Health and Welfare Notification No. 302, and can be sterilized by boiling.Furthermore, it does not cause corneal or retinal damage during surgery, and has good operability during surgery. It was hot.

【effect】

The ophthalmic surgery aid according to the present invention is formed into a substantially lens shape that can be worn on the cornea using a see-through material that blocks near-ultraviolet rays, and further includes a front surface located at a position offset from the center of the substantially lens-shaped body. Since the projecting part is configured on the ophthalmic surgery, if this ophthalmic surgical aid is attached to the cornea and ophthalmic surgery is performed, it is possible to significantly eliminate the occurrence of retinal damage and corneal damage caused by microscopic light. When suturing the sclerocornea, the strength of the suture can be determined by the degree of wrinkles that occur on the cornea, so the suturing work can be performed extremely accurately, and it also prevents the cornea from drying out even when exposed to light during surgery. It is also effective in prevention, and furthermore, the ophthalmic surgery aid can be removed from the cornea after surgery without damaging the cornea and can be done extremely easily.

[Brief explanation of drawings]

Fig. 1 is a perspective view of one embodiment of the ophthalmic surgery aid according to the present invention, Fig. 2 is an explanatory diagram of an operation performed using this ophthalmic surgery aid, and Fig. 3 shows the light transmittance. This is a graph showing. 1...Auxiliary tool for ophthalmic surgery, 2...Inner surface, 3...
Front surface, 4... axis (projection), 11... cornea, 12...
…light source.

Claims (1)

[Scope of Claims] 1. It is constructed in a substantially lens shape that can be worn on the cornea using a see-through material that blocks near ultraviolet rays, and furthermore, a protrusion is provided on the front surface of the substantially lens-shaped body at a position offset from the center. An ophthalmic surgery aid characterized by the following configurations: 2. The aid for ophthalmic surgery according to claim 1, in which the substantially lens-shaped body has a parallel curve or a shape having negative power. 3. The aid for ophthalmic surgery according to claim 1, which has a cutting range of near ultraviolet rays of at least about 320 to 400 nm, and has a cutting rate of about 30% or more in this cutting range. 4. In the ophthalmic surgery aid according to claim 1, the substantially lens-shaped body is made of a soft and see-through material that blocks ultraviolet rays and near ultraviolet rays. 5. In the ophthalmic surgery aid as set forth in claim 1, the substantially lens-shaped body is made of a soft, substantially water-free and see-through material that blocks ultraviolet rays and near ultraviolet rays. 6. In the ophthalmic surgery aid according to claim 1, 4, or 5, the substantially lens-shaped body is made of a silicone rubber material to which an ultraviolet and near ultraviolet absorber is added. 7. In the ophthalmic surgery aid as set forth in claim 6, the silicone rubber is mainly composed of dimethyl silicone. 8. In the ophthalmic surgery aid as set forth in claim 6, the silicone rubber is mainly composed of methylphenyl silicone. 9. An ophthalmic surgery aid according to claim 6, 7, or 8, wherein the surface of the silicone rubber substantially lens-shaped body is subjected to hydrophilic treatment.