JPH0724052A - Soft eye-inlying lens for correcting protanopia - Google Patents

Abstract

PURPOSE:To provide a soft inlying lens of eyes for correcting sufficiently protanopia which originates from aphakia after operation of cataract, wherein the lens can be inserted into eyes through a small incised part, and the lens is provided with characteristics of a lowering of content of additives like ultra- violet absorber which produces a low dissolution of additives out of a lens. CONSTITUTION:A soft inlying lens for eyes having transparent colored body, wherein the lens is made by admixing into a soft and transparent material with at least one of coloring material selected from the group of yellow, yellowish brown and orange color, and ultra-violet absorber.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a soft intraocular lens for correcting blue eyes, and more particularly to a soft intraocular lens for correcting blue eyes occurring in aphakic eye patients after cataract surgery.

[0002]

2. Description of the Related Art In recent years, the population of senile cataract patients has been increasing with the increase of the elderly population. Aphakic eye patients whose lenses have been removed by cataract surgery have their eyesight corrected by eyeglasses, contact lenses, or intraocular lenses.

In the case of spectacles, the correction lens is a thick convex lens, which is unsightly to look at, and the retinal image is larger than that of a normal eye. As a result, fatigue of the optic nerve and cranial nerve increases, and the burden on the user is large. On the other hand, as a contact lens, a highly oxygen permeable lens has been developed in recent years, and has become extremely effective for correcting visual acuity of aphakic patients.

Further, an intraocular lens which does not need to be removed by being embedded in the eye has been developed, and has recently been widely accepted as an alternative lens for cataract patients due to its excellent effect.

Many patients with aphakic eyes after cataracts complain of photophobia and discomfort in color, and in particular, blue vision, in which an object looks bluish, is generally well known. Blue eye syndrome is a symptom in which an object appears blue compared to a normal eye as a result of reaching the retina without blue light being attenuated due to the removal of the crystalline lens originally colored yellow or tan. Type artificial intraocular lens when inserted into the eye
In the eye with the MMA (polymethylmethacrylate) posterior chamber lens inserted, blue light reaches the retina without being attenuated, and therefore, the color discrimination ability in blue to violet is lower than that in the phakic eye.

[0006] Therefore, an intraocular lens capable of correcting blue eyes is desired, and a hard lens is made to have a yellow, yellowish brown or orange colorant or the colorant and an ultraviolet absorber so as to approximate the crystalline absorption characteristics of the human eye. A hard intraocular lens was developed (W
No. 089/07952) and commercialized.

However, since a hard intraocular lens insertion operation requires a wide incision of about 6 to 8 mm, it is said that astigmatism frequently occurs after lens insertion. In order to improve this point, recently, a soft intraocular lens having rubber elasticity that can be inserted through a small incision of 2 to 3 mm has been developed and spread. In such a soft intraocular lens having rubber elasticity, a non-hydrous soft intraocular lens containing an ultraviolet absorber is also disclosed for the purpose of absorbing ultraviolet light (Japanese Patent Laid-Open No. 1-244762).

[0008]

However, in the above-mentioned intraocular lens containing the ultraviolet absorber, the ultraviolet absorber is 4
Although harmful UV rays of 00 nm or less can be cut off, visible blue light cannot be absorbed, and thus correction of blue vision is incomplete.
Further, when a large amount of an ultraviolet absorber is used to increase absorption in the visible light region, the physical properties of the material are deteriorated, which is not preferable.

When a large amount of ultraviolet absorber is added to the lens base material-forming monomer mixture for polymerization to obtain a lens, problems such as decomposition of the ultraviolet absorber occur during polymerization, which adversely affects the polymerization operation. Also, problems such as elution of the ultraviolet absorber occur when the lens is used.

The object of the present invention is to add a small amount of additives such as an ultraviolet absorber, which can be inserted through a small incision and can sufficiently correct blue vision occurring in the aphakic eye after cataract surgery. It is intended to provide a soft intraocular lens which can be suppressed and has advantages such as a small amount of eluate.

[0011]

The present invention has been made to achieve the above object, and a soft intraocular lens for correcting blue eyesight according to the present invention comprises a soft transparent lens material including yellow and yellowish brown. And at least one selected from orange colorants and a transparent coloring material obtained by mixing an ultraviolet absorber.

The present invention will be described in detail below. The soft transparent lens material that constitutes the base material of the blue eye correction soft intraocular lens of the present invention is particularly limited as long as it has rubber elasticity and has the characteristics required as the soft intraocular lens material. Not something. For example, examples of the silicone-based material include one-component and two-component type liquid silicone rubbers that cure by condensation or addition reaction. Such liquid silicone rubber is known as RTV (Room Temperature V
ulcanizing) Silicone rubber (referred to as RTV rubber), which is cured into a rubber elastic body at room temperature to 70 ° C. In the one-pack type, the main agent mainly cures by reacting with moisture in the air to be cured, while in the two-pack type, the reaction is initiated by mixing two liquids of the main agent and the curing agent at a predetermined ratio at the time of use, and rubber elasticity The body. As liquid silicone rubber,
Any material may be used as long as it has good transparency, deep-part curability and shrinkage upon curing.

As the acrylic material, for example,
Methyl methacrylate and long chain acrylate or methacrylate (n-butyl acrylate, n-hexyl acrylate, n-octyl acrylate, nonyl acrylate, lauryl acrylate, stearyl acrylate, 2-ethylhexyl methacrylate, nonyl methacrylate, lauryl methacrylate, stearyl methacrylate, etc.) And a copolymer obtained by copolymerizing the above in the presence of a crosslinking agent (ethylene glycol dimethacrylate, allyl methacrylate, trimethylolpropane trimethacrylate, etc.). The long-chain acrylates or methacrylates are used alone or in combination of two or more, and the glass transition temperature of these is preferably 30 ° C. or lower. Further, as the above-mentioned monomer copolymerized with methyl methacrylate, a monomer such as a fluorinated acrylate or a fluorinated methacrylate can be selected.

It is desirable that the yellow, yellowish brown or orange colorant and the ultraviolet absorber be mixed into the soft transparent lens material having rubber elasticity at the same time when the soft base material is manufactured. That is, a colored intraocular lens in which the colorant and the ultraviolet absorber are molecularly dispersed can be obtained by adding the colorant and the ultraviolet absorber to the intraocular lens base material-forming monomer mixture and performing cast polymerization. Note that various compression molding methods may be used instead of the above-mentioned cast polymerization.

The colorant is the most important substance in the soft intraocular lens for correcting blue eye of the present invention, and the compound used as the colorant is yellow, tan or orange, and preferably has a maximum absorption wavelength of 320 to 320. Compounds between 450 nm are compatible.

Examples of colorants include CI Solvent Yellow (Solv) described in Color Index (CI).
ent Yellow), CI Solvent Orange (Solvent Or
oil-soluble dyes such as ange) or disperse dyes such as CI Disperse Yellow and CI Disperse Orange are preferable. Other than the above, any colorant having a good compatibility with the lens material may be used.

Although the yellow colorant is not limited to these, CI Solvent Yellow 16, CI Solvent Yellow 29, CI Solvent Yellow 3
3, CI Solvent Yellow 44, CI Solvent
Yellow 56, CI Solvent Yellow 77, CI Solvent Yellow 93, CI Disperse Yellow 3 and the like. The yellow-brown colorant is not limited to these, but is CI Solvent Yellow 14, CI Solvent Yellow 104, CI Solvent Yellow 105, CI Solvent Yellow 11
0, CI solvent yellow 112, CI solvent yellow 113, CI solvent yellow 114, and the like. Further, the orange colorant is not limited to this, but may be CI solvent orange 6
0, CI solvent orange 67, CI solvent
Orange 68, CI Solvent Orange 79, CI Solvent Orange 80, CI Solvent Orange 8
6, CI Disperse Orange 47.

A particularly preferred colorant is CI solvent.
Yellow 93, CI Solvent Yellow 44, CI Solvent Yellow 16, CI Solvent Yellow 7
7, CI Disperse Yellow 3 and other compounds having a maximum absorption wavelength in the vicinity of 350 to 400 nm. These colorants have the advantage of absorbing visible light of 400 to 500 nm and also capable of simultaneously absorbing light of 300 to 400 nm, which is the ultraviolet absorption region of the crystalline lens, but are sufficiently satisfactory for correcting blue eyes. is not.

In the soft intraocular lens for correcting blue eyes of the present invention, the light absorption at 300 to 400 nm can be arbitrarily adjusted by using the ultraviolet absorber together with the colorant as described above. Therefore, by selecting the type and addition concentration of the colorant in accordance with the visible part absorption characteristics of the human eye lens, and supplementing the insufficient absorption in the ultraviolet with an ultraviolet absorber, the light absorption characteristics of the human eye lens are further improved. It is possible to get closer.

Examples of such an ultraviolet absorber include (1) benzotriazole-based 2- (2'-hydroxy-3'-tert-butyl-
5'-methylphenyl) -5-chlorobenzotriazole (Tinuvin 326, manufactured by Ciba-Geigy) 2- (2'-hydroxy-5'-methylphenyl) benzotriazole (Tinuvin P, manufactured by Ciba-Geigy) 2- (2 '-Hydroxy-3', 5'-di-tert
-Butylphenyl) benzotriazole (Tinuvin 32
0, manufactured by Ciba Geigy) 2- (2'-hydroxy-3 ', 5'-di-tert
-Butylphenyl) -5-chlorobenzotriazole (Tinuvin 327, manufactured by Ciba Geigy). 2- (2'-hydroxy-3 ', 5'-di-tert.
-Amylphenyl) benzotriazole (Tinuvin 32
(8, manufactured by Ciba-Geigy) (2) Benzophenone-based 2,4-dihydroxybenzophenone 2-hydroxy-4-methoxybenzophenone 2-hydroxy-4-octoxybenzophenone 2-hydroxy-4-dodecyloxybenzophenone 2,2'-dihydroxy- 4-methoxybenzophenone 2,2'-dihydroxy-4,4'-dimethoxybenzophenone 2-hydroxy-4-methoxy-5-sulfobenzophenone (3) salicylic acid phenyl salicylate p-tert-butylphenyl salicylate p-octylphenyl salicylate, etc. Is mentioned.

Reactive UV absorbers having the same chemical structure as those of these UV absorbers and having a part capable of copolymerizing with the intraocular lens base material forming monomer can also be used. Examples thereof include 2-hydroxy-4-acryloyloxyethoxybenzophenone and 2 (2-hydroxy-4-methacryloyloxyethoxy) -4-chlorobenzotriazole.

Conventionally, when an ultraviolet absorber is used for the purpose of absorbing ultraviolet rays, it is necessary to use a large amount of 0.5 to 10% by weight. As a result, a large amount of the ultraviolet absorber is used in the production of lens materials. It may hinder the polymerization reaction of (1) and cause various problems such as deterioration of physical properties of the lens material. For example, deterioration of physical properties such as solvent resistance, heat resistance and elasticity, coloring agent, bleeding of ultraviolet absorber (development in which the added coloring agent and ultraviolet absorber float on the polymer surface), and elution thereof are mentioned.

On the other hand, in the soft intraocular lens for correcting blue eyes of the present invention, since the coloring agent used has a great coloring effect, the mixing amount of the coloring agent can be reduced. The amount of the colorant mixed in is extremely small, 0.1% by weight or less with respect to the lens material, and the amount of the ultraviolet absorber mixed in can be extremely low, 0.1% by weight or less. Therefore, it has an excellent feature that adverse effects such as elution of the colorant and the ultraviolet absorber are reduced. A particularly preferable amount of the colorant mixed is 0.
01 to 0.04% by weight, and particularly preferable amount of the ultraviolet absorber mixed is 0.01 to 0.08% by weight.

[0024]

The present invention will be described in more detail with reference to the following examples. (Example 1) Two-component liquid silicone rubber base agent (trade name:
KE106, manufactured by Shin-Etsu Chemical Co., Ltd.) 52.3 g and a curing agent (trade name: Cat-RG, manufactured by Shin-Etsu Chemical Co., Ltd.)
After uniformly mixing with 5.9 g, 12 mg (0.
021 wt% CI Solvent Yellow 93 and 4
2.0 mg (0.072% by weight) of 2- (2'hydroxy-3'-tert-butyl-5'-methylphenyl)
-5-Chlorobenzotriazole (Tinuvin 326, manufactured by Ciba Geigy) and 25 ml of methylene chloride were added, and the mixture was sufficiently stirred until the colorant and the ultraviolet absorber were uniformly dissolved. Then, the solvent was removed under reduced pressure, and the mixture was placed in a polymerization mold having a predetermined intraocular lens shape and polymerized at 60 ° C. for 48 hours to prepare a + 20D non-hydrated intraocular lens.

The intraocular lens absorbed a light ray of 300 to 450 nm as shown by the curve (a) in FIG. 1, although the mixing amount of the coloring agent and the ultraviolet absorber was extremely small. In particular, it was possible to absorb ultraviolet rays of 320 to 400 nm, which are harmful to the eyes, and light of 400 to 450 nm, which is the original colored region of the crystalline lens, and the light absorption characteristics were close to those of the crystalline lens of the human eye.

(Comparative Example 1) 2- (2'hydroxy-3'-t-butyl-) was used as an ultraviolet absorber without adding a coloring agent.
A + 20D intraocular lens was produced in the same manner as in Example 1 except that 0.25% by weight of 5'-methylphenyl) -5-chlorobenzotriazole (Tinuvin 326, manufactured by Ciba Geigy) was added. Although the intraocular lens absorbed a light ray of 300 to 390 nm as shown by the curve (b) in FIG. 1 in spite of the large amount of the ultraviolet absorber mixed therein, it is an original colored region of the human eye crystalline lens. There was no light absorption at 400 to 450 nm. Further, bleeding from the lens to the surface of the ultraviolet absorber was observed with the passage of time.

Example 2 As monomers, 50 g of methyl methacrylate, 50 g of n-butyl acrylate,
5 g of ethylene glycol dimethacrylate and 0.1% by weight of azobisdimethylvaleronitrile as a radical polymerization initiator were added to the monomers, and they were mixed uniformly. Then, 0.02% by weight of CI Solvent Yellow 77 and 0.02% by weight of 2-hydroxy-4-acryloyloxyethoxybenzophenone were added and sufficiently stirred, and then put into a polymerization mold having a predetermined intraocular lens shape. , 6
Polymerization was performed at 0 ° C. to 110 ° C. for 60 hours to prepare a + 20D non-hydrated intraocular lens.

The present intraocular lens absorbed a light ray of 300 to 450 nm as shown by the curve (a) in FIG. 2, although the mixing amount of the colorant and the ultraviolet absorber was extremely small. In particular, it is possible to absorb ultraviolet rays harmful to the eye of 320 to 400 nm and light of 400 to 450 nm which is the original colored region of the human eye crystalline lens, which is close to the light absorption characteristics of the human eye crystalline lens.

Example 3 As a monomer, 60 g of methyl methacrylate, 40 g of nonyl acrylate, 5 g of ethylene glycol dimethacrylate, and 0.1% by weight of azobisdimethylvaleronitrile as a radical polymerization initiator were added to the monomer and mixed uniformly. It was Then 0.02% by weight of CI Solvent Yellow 7
7, 0.02% by weight of 2- (2'-hydroxy-3 ',
5-di-t-amylphenyl) benzotriazole (Tinuvin 328, manufactured by Ciba Geigy) was added and sufficiently stirred, and then placed in a polymerization mold having a predetermined intraocular lens shape, and 60
Polymerization was performed at 60 ° C to 110 ° C for 60 hours to prepare a + 20D non-hydrated intraocular lens.

The present intraocular lens absorbed a light ray of 300 to 450 nm as shown by the curve (a) in FIG. 3, although the mixing amount of the coloring agent and the ultraviolet absorber was extremely small. In particular, it is possible to absorb ultraviolet rays harmful to the eye of 320 to 400 nm and light of 400 to 450 nm which is the original colored region of the human eye crystalline lens, which is close to the light absorption characteristics of the human eye crystalline lens.

Further, using the aqueous extracts of the intraocular lenses obtained in Examples 1 to 3 and Comparative Example 1, a potassium permanganate reducing substance test and an ultraviolet absorption spectrum test were conducted, and suitability as an intraocular lens. Was evaluated.

Water extraction from the intraocular lens was performed by the following method. Samples (Examples 1 to 1) in a 100 ml round bottom flask.
3) and 5 g of each of the intraocular lenses of Comparative Example 1 and 100 ml of distilled water are added, and the mixture is heated at 100 ° C. for 30 minutes with a reflux condenser and cooled to room temperature to obtain an extract.
The following test is performed using this extract as a test solution.

(A) Test for reducing potassium permanganate reducing substance 10 ml of the test solution was placed in an Erlenmeyer flask, 20 ml of 0.01N potassium permanganate solution and 1.0 ml of dilute sulfuric acid were added, and the mixture was boiled for 3 minutes and cooled. Add 0.1 g of potassium iodide and 5 drops of starch test solution, and titrate with 0.01N sodium thiosulfate solution. Water 1 instead of test solution
Using 0 ml and operating in the same manner, the difference in consumption of the potassium permanganate solution between the test solution and water is determined. According to the intraocular lens approval criteria, this difference should be less than 1.0 ml.

(B) Ultraviolet absorption spectrum test With respect to the test solution, the absorbance at a wavelength of 220 to 350 nm is measured in a 10 mm square cell with water as a control. According to the intraocular lens approval standard, this absorbance should be less than 0.1.

The test results are shown in Table 1.

[0036]

[Table 1] From Table 1, the intraocular lens of Comparative Example 1 does not meet the intraocular lens approval criteria in both the potassium permanganate reducing substance test and the ultraviolet absorption spectrum test, and is not suitable as an intraocular lens, but Examples 1 to 3 It is clear that the intraocular lens of 1) is suitable for all tests and is preferably used as the intraocular lens.

[0037]

As described above in detail, the soft intraocular lens for correcting blue eyes of the present invention can be inserted through a small incision, can efficiently correct blue eyes, and can be eluted. It has a remarkable effect such as less.

[Brief description of drawings]

FIG. 1 is a transmittance curve diagram of an intraocular lens of Example 1, an intraocular lens of Comparative Example 1, a PMMA intraocular lens, and a human eye crystalline lens.

FIG. 2 is a transmittance curve diagram of the intraocular lens of Example 2.

FIG. 3 is a transmittance curve diagram of the intraocular lens of Example 3.

Claims (2)

[Claims] 1. A blue colored transparent material obtained by mixing a soft transparent lens material with at least one colorant selected from yellow, yellowish brown and orange colorants and an ultraviolet absorber. Flexible intraocular lens for correction of vision. 2. The content of the coloring agent in the soft transparent lens is 0.1% by weight or less, and the content of the ultraviolet absorber is 0.1.
The soft intraocular lens for correcting blue eyesight according to claim 1, wherein the intraocular lens is blue or white.