Correction of defects in the eye and compositions therefor

• US 4,608,050 A
• Filed: 07/21/1983
• Issued: 08/26/1986
• Est. Priority Date: 07/21/1983
• Status: Expired due to Term

• Current Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Original Assignee: Innovative Surgical Products, Inc. (Innovative Specialty Silicone Acquisition Corp.)
• Inventors: Wright, George M., Talcott, Thomas D.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Isabella, David J.
• Application Number:
  US06/515,790
• Time in Patent Office: 1,132 Days
• Field of Search: 623/4, 623/5, 623/6, 528/15, 528/81, 528/82, 128/1 R
• US Class Current: 623/6.56
• CPC Class Codes: A61F 2/1613 having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
• CPC Class Codes: A61F 2/1616 Pseudo-accommodative, e.g. multifocal or enabling monovision
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence

Abstract

In a method of treating defective lenses in the eye, the natural lens is removed leaving the lens capsule intact. A curable liquid composition comprising (a) a crosslinkable siloxane polymer, (b) a crosslinker, and (c) a crosslinking catalyst is injected into the lens capsule where the composition cures at body temperature to a solid, transparent synthetic lens which remains clear in the presence of physiological fluids.

Claims

1. A method of replacing the lens in the eye of a human being or other animal in vivo which comprises:

introducing into the lens capsule, from which the natural lens has been removed, a curable liquid silicone polymer composition comprising crosslinkable silicone polymer and a crosslinker through a needle inserted into a hole in the lens capsule;

sealing the hole in the lens capsule by curing the polymer composition that is in the vicinity of the hole to an extent sufficient to prevent loss of said composition from the lens capsule prior to withdrawing the needle from the hole; and

;

curing said composition to form in situ a clear, synthetic lens.

6. A method as claimed in any of claims 1, 3, 4 or 5 which comprises the preliminary step of gradually breaking up and removing the natural lens to leave the lens capsule substantially intact.

7. A method as claimed in claim 6, wherein said natural lens is broken up by ultrasonic or mechanical means.

8. A method as claimed in any one of claims 1 to 5, wherein said silicone composition comprises:

(a) a crosslinkable organosiloxane polymer;

(b) a crosslinker; and

(c) a catalyst for the crosslinking reaction between (a) and (b).

9. A method as claimed in claim 6, wherein said silicone composition comprises:

(a) a crosslinkable organosiloxane polymer;

(b) a crosslinker; and

(c) a catalyst for the crosslinking reaction between (a) and (b).

10. A method as claimed in claim 7, wherein said silicone composition comprises:

(a) a crosslinkable organosiloxane polymer;

(b) a crosslinker; and

(c) a catalyst for the crosslinking reaction between (a) and (b).

19. A method as claimed in claim 8, wherein said crosslinking component (b) has at least one of the following general formula:

##STR21## wherein the R substituents are the same or different and are as defined above, R'"'"' is as defined in Formula VI above, R'"'"' here being hydrogen when R'"'"' in Formula V is alkenyl, and vice versa; and

q is an average number from about 1 to 250 times the value of q'"'"';

preferably q'"'"' is an average number of from about 3 to 20;

the material of Formula VIII having an average degree of polymerization of from about 50 to 5,000, the average value of q being determined by the difference between the degree of polymerization and the average value of q'"'"';

##STR22## wherein M is a monofuntional, silicon-containing, chain-capping residue;

D is a difunctional siloxane monomer unit;

T is a trifunctional siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

wherein n and x are average positive numbers, m is 0 or an average positive number, the total of n m being from about 2 to 100 and, when m=0, n alone has these values, the degree of polymerization (DP) being from 50 to 5,000. ##STR23## wherein R and R¹ are as defined above, n is an average number substantially equal to the average degree of polymerization of the material which is from about 50 to 5,000.

20. A method as claimed in claim 8, wherein said catalyst component (c) comprises a platinum compound.

21. A method as claimed in claim 20, hwerein said platinum compound comprises chloroplatinic acid.

22. A method as claimed in claim 8, wherein said silicone composition is substantially curable at body temperature and is curable to an optically clear material which remains so in the presence of physiological fluids.

23. A method as claimed in any of claims 1 to 5 wherein said silicone composition comprises:

(a) a high molecular weight, organosiloxane polymer containing crosslinkable groups;

(b) a high molecular weight organosiloxane crosslinker containing groups crosslinkable with said crosslinkable groups in component (a); and

(c) a catalyst which promots the crosslinking reaction between components (a) and (b).

24. A method as claimed in claim 23, wherein the average degree of polymerization of component (a) is from about 100 to 20000.

25. A method as claimed in claim 23, wherein the average degree of polymerization of component (b) is from about 200 to 1000.

26. A method as claimed in claim 23, wherein components (a) and (b) are substantially free of polar or ionic groups.

27. A method as claimed in claim 26 wherein said components (a) and (b) are prepared by polymerization in the presence of an acid catalyst.

28. A method as claimed in any of claims 23 to 27, wherein said composition is curable, substantially at body temperature, from an optically clear composition that remains so in the presence of physiological fluids.

2. A method of using the lens capsule in the eye of a human being or other animal as a mold to form a synthetic lens in vivo which comprises:

removing the natural lens from said lens capsule to leave said capsule intact;

replacing said natural lens with a mobile crosslinkable silicone polymer composition through a needle inserted into a hole in the lens capsule;

sealing the hole in the lens capsule by curing the polymer composition that is in the vicinity of the hole to an extent sufficient to prevent loss of said composition from the lens capsule prior to withdrawing the needle from the hole; and

curing said composition to a solid shape determined by the lens capsule.

3. A method of forming in vivo a replacement lens in the eye of a human being or other animal which comprises:

introducing into the lens capsule, from which the natural lens has been previously removed, a silicone lens composition, which undergoes a physical change in said capsule to form said replacement lens, through a needle inserted into a hole in the lens capsule; and

sealing the hole in the lens capsule by curing the composition that is in the vicinity of the hole to an extent sufficient to prevent loss of said composition from the lens capsule prior to withdrawing the needle from the hole.

4. A method as claimed in claim 3, wherein said silicone lens composition is injected into said lens capsule as a viscous liquid which solidifies in said capsule.

11. A method as claimed in claim 3, wherein component (a) comprises polymer having the average formula:

##STR14## wherein;

M is a monofunctional, silicon-containing, chain capping residue;

D is a difunctional, siloxane monomer unit, T is a trifunctional, siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

m and n are average numbers whose total is from about 2 to about 1000, n being a positive number greater than zero, M being zero or a positive number greater than zero;

the average degree of polymerization of said polymer being from about 100 to about 20000, the valve of said degree of polymerization and m and n determining the average value of x.

12. A method as claimed in claim 11, wherein said monofunctional units M are derived from polymerization of a polyorganosiloxane of the formula ##STR15## where the R radicals do not take part in the cross-linking reaction and are substituted or unsubstituted and are the same or different radicals selected from:

alkyl, aryl, alkaryl and aralkyl; and

wherein m is an average number up to about 30.

13. A method as claimed in claim 12, wherein said R radicals are each methyl radicals.

14. A method as claimed in claim 11, wherein said difunctional units D are derived from polymerization of a mixture of siloxanes of formula (IV) and (V) below:

##STR16## wherein the R radicals do not take part in the cross-linking reaction and are substituted or unsubstituted and are the same or different radicals and are selected from the group consisting of alkyl, aryl, alkaryl and arakyl, said siloxane of formula (IV) being linear or cyclic, but when linear ##STR17## wherein R is as defined above and E is chloro, methoxy, ethoxy, acetoxy or hydroxy; and

p is from 1 to 200;

and when cyclic, A and B are chemical bonds joined together; and

p is from 3 to 8;

##STR18## wherein, A, B, R and p are as defined above, and R¹ is H or alkenyl.

15. A method as claimed in claim 11, wherein said trifunctional units T are derived from polymerization of at least one silicon compound of the formula:

##STR19## wherein R² is R or R¹ does not take part in the cross-linking reaction and is substituted or unsubstituted and selected from the group consisting of alkyl, aryl, alkaryl and arakyl and R¹ is H or alkenyl; and

W, Y and Z are the same of different substituents which in the formation of said crosslinkable polymer are converted to volatile or otherwise easily removable by-products.

16. A method as claimed in claim 15, wherein W, Y and Z are selected from C₁ -C₆ alkoxy, acetoxy, chloro and hydroxy.

17. A method as claimed in claim 11, wherein said tetrafunctional residues Q are derived from polymerization of at least one silicon compound of the formula:

##STR20## Wherein W, X, Y and Z are the same or different substituents which in the formation of said crosslinkable polymer are converted to volatile or otherwise easily removable by-products.

18. A method as claimed in claim 17, wherein W, X, Y and Z are selected from, C₁ -C₆ alkoxy, acetoxy, chloro and hydroxy.

5. A method of forming a synthetic lens in the lens capsule of an eye which is without a lens which comprises:

introducing a curable silicone composition into said capsule, where said composition forms a self-supportable lens, through a needle inserted into a hole in the lens capsule, and

sealing the hole in the lens casule by curing the composition that is in the vicinity of the hole to an extent sufficient to prevent loss of said composition from the lens capsule prior to withdrawing the needle from the hole.

29. A method of replacing the lens in the eye of a human being or other animal in vivo which comprises:

introducing into the lens capsule, from which the natural lens has been removed, a curable liquid silicone polymer composition comprising crosslinkable silicone polymer and a crosslinker and

curing said composition to form in situ a clear, synthetic lens, said composition being substantially curable at body temperature to form a lens which is optically clear and remains so in the presence of physiological fluids, said composition comprising;

(a) a crosslinkable organosiloxane polymer containing crosslinkable hydrogen or alkenyl groups and having the average formula;

##STR24## wherein;

M is a monofunctional, silicon-containing, chain capping residue D is a difunctional, siloxane monomer unit, T is a trifunctional, siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

m and n are average numbers whose total is from about 2 to about 1000, n being a positive number greater than zero, m being zero or a positive number greater than zero;

the average degree of polymerization of said polymer being from about 100 to about 20000, the value of said degree of polymerization and m and n determining the average value of x;

(b) an organosiloxane crosslinker polymer containing alkenyl groups when polymer (a) contains said crosslinkable hydrogen groups or hydrogen groups when said polymer (a) contains said crosslinkable alkenyl groups, polymer (b) having at least one of the following general formula (i), (ii) and (iii);

##STR25## wherein the R substituents are substituted or unsubstituted and are the same or different and are selected from the group consisting of alkyl, aryl, alkaryl and aralkyl;

R¹ is hydrogen or alkenyl; and

q is an average number from about 1 to 250 times the value of q'"'"', q'"'"' being an average number of from about 3 to 20;

the material of Formula VIII having an average degree of polymerization of from about 50 to 5,000, the average value of q being determined by the difference between the degree of polymerization and the average value of q'"'"';

##STR26## wherein M is a monofunctional, silicon-containing, chain-capping residue which is free of said crosslinkable groups;

D is a difunctional siloxane monomer unit;

T is a trifunctional siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

wherein n and x are average positive numbers, m and 0 or an average positive number, the total of n m being from about 2 to 100 and, when m=0, n alone has these values, the degree of polymerization (DP) being from 50 to 5,000; and

##STR27## wherein R and R¹ are as defined above, n is an average number substantially equal to the average degree of polymerization of the material which is from about 50 to 5,000; and

(c) a platinum complex catalyst capable of promoting a crosslinking reaction between said hydrogen or alkenyl groups in polymer (a) and said alkenyl or hydrogen groups in polymer (b).

33. A method as claimed in claims 29, 30, 31 or 32, wherein both before and after cure, less than about 40% to 50% by weight of said composition is extractable by solvent.

34. A method as claimed in claim 33, wherein less than about 30% by weight of said composition is extractable by solvent.

35. A method as claimed in claims 29, 30, 31 or 32, wherein said composition is curable to a lens having a refractive index of about 1.4.

36. A method as claimed in claim 29, 30, 31 or 32 wherein said monofunctional units M are derived from polymerization of a polyorganosiloxane of the formula ##STR40## where the R radicals do not take part in the cross-linking reaction and are substituted or unsubstituted and are the same or different radicals selected from:

alkyl, aryl, alkaryl and aralkyl; and

wherein m is an average number up to about 30.

37. A method as claimed in claim 36, wherein said R radicals are each methyl radicals.

38. A method as claimed in claim 29, 30, 31 or 32, wherein said difunctional units D are derived from polymerization of a mixture of siloxanes of formula (IV) and (V) below:

##STR41## wherein the R radicals do not take part in the cross-linking reaction and are substituted or unsubstituted and are the same or different radicals and are selected from the group consisting of alkyl, aryl, alkaryl and aralkyl, said siloxane of formula (IV) being linear or cyclic, but when linear ##STR42## wherein R is as defined above and E is chloro, methoxy, ethoxy, acetoxy or hydroxy; and

p is from 1 to 200;

and when cyclic, A and B are chemical bonds joined together; and

p is from 3 to 8;

##STR43## wherein, A,B,R and p are as defined above, and R¹ is H or alkenyl.

39. A method as claimed in claim 29, 30, 31 or 32, wherein said trifunctional units T are derived from polymerization of at least one silicon compound of the formula:

##STR44## wherein R² is R or R¹ and R does not take part in the cross-linking reaction and is substituted or unsubstituted and selected from the group consisting of alkyl, aryl, alkaryl, and aralkyl, and R¹ is H or alkenyl; and

W,Y and Z are the same of different substituents which in the formation of said crosslinkable polymer are converted to volatile or otherwise easily removable by-products.

40. A method as claimed in claim 39, wherein W, Y and z are selected from C₁ -C₆ alkoxy, acetoxy, chloro and hydroxy.

41. A method as claimed in claim 29, 30, 31 or 32, wherein said tetrafunctional residues Q are derived from polymerization of at least one silicon compound of the formula:

##STR45## wherein W, X, Y and Z are the same or different substituents which in the formation of said cross-linkable polymer are converted to volatile or otherwise easily removable by-products.

42. A method as claimed in claim 41, where W, X, Y and Z are selected from C₁ -C₆ alkoxy, acetoxy, chloro and hydroxy.

43. A method as claimed in claim 29, 30, 31 or 32, wherein said catalysts component (c) comprises a platinum compound.

44. A method as claimed in claim 43, wherein said platinum compound comprises chloroplatinic acid.

45. A method as claimed in claim 29, 30, 31 or 32, wherein components (a) and (b) are substantially free of polar or ionic groups.

46. A method as claimed in claim 45, wherein said components (a) and (b) are prepared by polymerization in the presence of an acid catalyst.

47. A method as claimed in claim 29, 30, 31 or 32, wherein polymer (a) is prepared from octamethylcyclotetrasiloxane;

polydimethylsiloxane;

tetravinyltetramethylcylotetrasiloxane; and

methyltriacetoxy-silane.

48. A method as claimed in claim 29, 30, 31 or 32, wherein polymer (a) is prepared from octamethylcyclotetrasiloxane;

polydimethylsiloxane;

1,1,2,2,-tetramethyl-1,2-divinyldisiloxane; and

methyltriacetoxy-silane.

49. A composition as claimed in claim 29, 30, 31 or 32 wherein polymer (a) is prepared from dimethyldichlorosilane;

octamethylcyclotetrasiloxane;

trimethylchlorosilane, and vinyltri-chlorosilane.

50. A composition as claimed in claim 29, 30, 31 or 32 wherein polymer (a) is prepared from dimethyldichlorosilane;

octamethylcyclotetrasiloxane;

trimethylchlorosilane;

vinyltrichlorosilane; and

methyltrichlorosilane.

51. A method as claimed in claim 29, 30, 31 or 32, wherein polymer (a) is prepared from octamethylcyclotetrasiloxane;

polydimethylsiloxane;

vinyldiacetoxysilane; and

methyltriacetoxysilane.

52. A method as claimed in claim 29, 30, 31 or 32, wherein polymer (a) is prepared from octamethylcyclotetrasiloxane;

polydimethylsiloxane;

vinyltriacetoxysilane; and

tetracetoxysilane.

53. A composition as claimed in claims 29, 30, 31 or 32 wherein polymer (b) is prepared from polymethylhydrogensiloxane and octamethylcyclotetrasiloxane.

30. A method of using the lens capsule in the eye of a human being or other animal as a mold to form a synthetic lens in vivo which comprises:

removing the natural lens from said lens capsule to leave said capsule intact;

replacing said natural lens with a mobile crosslinkable silicone polymer composition and

curing said composition to a solid shape determined by the lens capsule, said composition being substantially curable at body temperature to form a lens which is optically clear and remains so in the presence of physiological fluids, said composition comprising;

(a) a crosslinkable organosiloxane polymer containing crosslinkable hydrogen or alkenyl groups and having the average formula;

##STR28## wherein;

M is a monofunctional, silicon-containing, chain capping residue D is a difunctional, siloxane monomer unit, T is a trifunctional, siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

m and n are average numbers whose total is from about 2 to about 1000, n being a positive number greater than zero, m being zero or a positive number greater than zero;

the average degree of polymerization of said polymer being from about 100 to about 20000, the value of said degree of polymerization and m and n determining the average value of x;

(b) an organosiloxane crosslinker polymer containing alkenyl groups when polymer (a) contains said crosslinkable hydrogen groups or hydrogen groups when said polymer (a) contains said crosslinkable alkenyl groups, polymer (b) having at least one of the following general formula (i), (ii) and (iii);

##STR29## wherein the R substituents are substituted or unsubstituted and are the same or different and are selected from the group consisting of alkyl, aryl, alkaryl and aralkyl;

R¹ is hydrogen or alkenyl; and

q is an average number from about 1 to 250 times the value of q'"'"', q'"'"' being an average number of from about 3 to 20;

the material of Formula VIII having an average degree of polymerization of from about 50 to 5,000, the average value of q being determined by the difference between the degree of polymerization and the average value of q'"'"';

##STR30## wherein M is a monofunctional, silicon-containing, chain-capping residue which is free of said crosslinkable groups;

D is a difunctional siloxane monomer unit;

T is a trifunctional siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

wherein n and x are average positive numbers, m is 0 or an average positive number, the total of n m being from about 2 to 100 and, when m=0, n alone has these values, the degree of polymerization (DP) being from 50 to 5,000; and

##STR31## wherein R and R¹ are as defined above, n is an average number substantially equal to the average degree of polymerization of the material which is from about 50 to 5,000; and

(c) a platinum complex catalyst capable of promoting a crosslinking reaction between said hydrogen or alkenyl groups in polymer (a) and said alkenyl or hydrogen groups in polymer (b).

31. A method of forming in vivo a replacement lens in the eye of a human being or other animal which comprises:

introducing into the lens capsule, from which the natural lens has been previously removed, a silicone lens composition which undergoes a physical change in said capsule to form said replacement lens, said composition being substantially curable at body temperature to form a lens which is optically clear and remains so in the presence of physiological fluids, said composition comprising;

(a) a crosslinkable organosiloxane polymer containing crosslinkable hydrogen or alkenyl groups and having the average formula;

##STR32## wherein;

M is a monofunctional, silicon-containing, chain capping residue D is a difunctional, siloxane monomer unit, T is a trifunctional, siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

m and n are average numbers whose total is from about 2 to about 1000, n being a positive number greater than zero, m being zero or a positive number greater than zero;

the average degree of polymerization of said polymer being from about 100 to about 20000, the value of said degree of polymerization and m and n determining the average value of x;

(b) an organosiloxane crosslinker polymer containing alkenyl groups when polymer (a) contains said crosslinkable hydrogen groups or hydrogen groups when said polymer (a) contains said crosslinkable alkenyl groups, polymer (b) having at least one of the following general formula (i), (ii) and (iii);

##STR33## wherein the R substituents are substituted or unsubstituted and are the same or different and are selected from the group consisting of alkyl, aryl, alkaryl and aralkyl;

R¹ is hydrogen or alkenyl; and

q is an average number from about 1 to 250 times the value of q'"'"', q'"'"' being an average number of from about 3 to 20;

the material of Formula VIII having an average degree of polymerization of from about 50 to 5,000, the average value of q being determined by the difference between the degree of polymerization and the average value of q'"'"';

##STR34## wherein M is a monofunctional, silicon-containing, chain-capping residue which is free of said crosslinkable groups;

D is a difunctional siloxane monomer unit;

T is a trifunctional siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

wherein n and x are average positive numbers, m is 0 or an average positive number, the total of n m being from about 2 to 100 and, when m=0, n alone has these values, the degree of polymerization (DP) being from 50 to 5,000; and

##STR35## wherein R and R¹ are as defined above, n is an average number substantially equal to the average degree of polymerization of the material which is from about 50 to 5,000; and

(c) a platinum complex catalyst capable of promoting a crosslinking reaction between said hydrogen or alkenyl groups in polymer (a) and said alkenyl or hydrogen groups in polymer (b).

32. A method of forming a synthetic lens in the lens capsule of an eye which is without a lens which comprises:

introducing a curable silicone composition into said capsule where said composition forms a self-supportable lens said composition being substantially curable at body temperature to form a lens which is optically clear and remains so in the presence of physiological fluids, said composition comprising;

(a) a crosslinkable organosiloxane polymer containing crosslinkable hydrogen or alkenyl groups and having the average formula;

##STR36## wherein;

M is a monofunctional, silicon-containing, chain capping residue D is a difunctional, siloxane monomer unit, T is a trifunctional, siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

m and n are average numbers whose total is from about 2 to about 1000, n being a positive number greater than zero, m being zero or a positive number greater than zero;

the average degree of polymerization of said polymer being from about 100 to about 20000, the value of said degree of polymerization and m and n determining the average value of x;

(b) an organosiloxane crosslinker polymer containing alkenyl groups when polymer (a) contains said crosslinkable hydrogen groups or hydrogen groups when said polymer (a) contains said crosslinkable alkenyl groups, polymer (b) having at least one of the following general formula (i), (ii) and (iii);

##STR37## wherein the R substituents are substituted or unsubstituted and are the same or different and are selected from the group consisting of alkyl, aryl, alkaryl and aralkyl;

R¹ is hydrogen or alkenyl; and

q is an average number from about 1 to 250 times the value of q'"'"', q'"'"' being an average number of from about 3 to 20;

the material of Formula VIII having an average degree of polymerization of from about 50 to 5,000, the average value of q being determined by the difference between the degree of polymerization and the average value of q'"'"';

##STR38## wherein M is a monofunctional, silicon-containing, chain-capping residue which is free of said crosslinkable groups;

D is a difunctional siloxane monomer unit;

T is a trifunctional siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

wherein n and x are average positive numbers, m is 0 or an average positive number, the total of n m being from about 2 to 100 and, when m=0, n alone has these values, the degree of polymerization (DP) being from 50 to 5,000; and

##STR39## wherein R and R¹ are as defined above, n is an average number substantially equal to the average degree of polymerization of the material which is from about 50 to 5,000; and

(c) a platinum complex catalyst capable of promoting a crosslinking reaction between said hydrogen or alkenyl groups in polymer (a) and said alkenyl or hydrogen groups in polymer (b).

54. A method of replacing the lens in the eye of a human being in vivo which comprises:

introducing into the lens capsule, from which the natural lens has been removed, a curable liquid silicone polymer composition curable at body temperature and comprising (a) crosslinkable silicone polymer and (b) a crosslinker, said component (a) comprises polymer having the average formula;

##STR46## wherein;

M is a monofunctional, silicon-containing, chain capping residue;

D is a difunctional, siloxane monomer unit, T is a trifunctional, siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

m and n are average numbers whose total is from about 2 to about 1000, n being a positive number greater than zero, M being zero or a positive number greater than zero;

the average degree of polymerization of said polymer being from about 100 to about 20000, the value of said degree of polymerization and m and n determining the average value of x; and

curing said composition to form in situ a lens which is optically clear and remains so in the presence of physiological fluids.

55. A method as claimed in claim 54, wherein said monofunctional units M are derived from polymerization of a polyorganosiloxane of the formula ##STR47## where the R radicals are do not take part in the crosslinking reaction and the same or different radicals selected from:

alkyl, aryl, alkaryl and aralkyl; and

wherein m is an average number up to about 30.

56. A method as claimed in claim 54, wherein said difunctional units D are derived from polymerization of a mixture of siloxanes of formula (IV) and (V) below:

##STR48## wherein the R radicals do not take part in the cross-linking reaction and are substituted or unsubstituted and are the same or different radicals and are selected from the group consisting of alkyl, aryl, alkaryl and arakyl, said siloxane of formula (IV) being linear or cyclic, but when linear ##STR49## wherein R is as defined above and E is chloro, methoxy, ethoxy, acetoxy or hydroxy; and

p is from 1 to 200;

and when cyclic, A and B are chemical bonds joined together; and

p is from 3 to 8;

##STR50## wherein, A,B,R and p are as defined above, and R¹ is H or alkenyl.

57. A method as claimed in claim 54, wherein said trifunctional units T are derived from polymerization of at least one silicon compound of the formula:

##STR51## wherein R² is R or R¹ and R does not take part in the cross-linking reaction and is substituted or unsubstituted and selected from the group consisting of alkyl, aryl, alkaryl and arakyl and R¹ is H or alkenyl; and

W,Y and Z are the same or different substituents which in the formation of said crosslinkable polymer are converted to volatile or otherwise easily removable by-products.

58. A method as claimed in claim 54, wherein said tetrafunctional residues Q are derived from polymerization of at least one silicon compound of the formula:

##STR52## wherein W, X, Y and Z are the same or different substituents which in the formation of said crosslinkable polymer are converted to volatile or otherwise easily removable by-products.

59. A method as claimed in claim 54, wherein said crosslinking component (b) has at least one of the following general formula:

##STR53## wherein the R substituents are the same or different and are as defined above, R'"'"' is as defined in Formula VI above, R'"'"' here being hydrogen when R'"'"' in Formula V is alkenyl, and vice versa; and

q is an average number from about 1 to 250 times the value of q'"'"';

preferably q'"'"' is an average number of from about 3 to 20;

the material of Formula VIII having an average degree of polymerization of from about 50 to 5,000, the average value of q being determined by the difference between the degree of polymerization and the average value of q'"'"';

##STR54## wherein M is a monofuntional, silicon-containing, chain-capping residue;

D is a difunctional siloxane monomer unit;

T is a trifunctional siloxane monomer unit; and

Q is a tetrafunctional siloxane monomer unit; and

wherein n and x are average positive numbers, m is 0 or an average positive number, the total of n m being from about 2 to 100 and, when m=0, n alone has these values, the degree of polymerization (DP) being from 50 to 5,000;

##STR55## wherein R and R¹ are as defined above, n is an average number substantially equal to the average degree of polymerization of the material which is from about 50 to 5,000.