Methods and compositions usable in cataract surgery

• US 20030014021A1
• Filed: 06/03/2002
• Published: 01/16/2003
• Est. Priority Date: 05/03/2001
• Status: Active Grant

• Current Assignee: Phacotreat AB
• Original Assignee: Phacotreat AB
• Inventors: Holmen, Jorgen
• Granted Patent: US 6,986,763 B2
• Time in Patent Office: Days
• US Class Current: 604/294
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00745 using mechanical vibrations, e.g. ultrasonic
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/12 for cataracts

Abstract

The invention relates to a method of performing ocular surgery, after an anterior capsulotomy has been made, by forming a sealed expanded capsular bag. The method includes sealing the capsular bag with a viscoelastic material to provide a gas tight seal to prevent leakage into the anterior chamber of the eye during the surgical process; expanding the capsular bag by introducing a gas capable of exerting a pressure on the inner surface of the capsular bag wall; inspecting and/or treating the capsular bag with one or several devices and/or agents suitable for performing inspection and/or treatment. The inspection and/or treatment can comprise any of visual inspection, estimation of capsular bag volume; labeling any residual epithelial cells to detect the presence thereof; removing residual epithelial cells, implanting one or more intracapsular implants; injecting a lens forming material for molding a lens in situ; drying the lens capsule; alone or in any combination. Use of a viscoelastic compound for the preparation of a temporary intraocular seal capable of sealing the capsular bag is also provided.

Claims

1. A method of performing ocular surgery, after an anterior capsulotomy has been made, by forming a sealed expanded capsular bag including the steps of

sealing the capsular bag with a viscoelastic material to provide a gas tight seal to prevent leakage into the anterior chamber of the eye during the surgical process;

expanding the capsular bag by introducing a gas capable of exerting a pressure on the inner surface of the capsular bag wall,

inspecting and/or treating the capsular bag with one or several devices and/or agents suitable for performing inspection and/or treatment.

2. A method according to claim 1, wherein the step of inspecting and/or treatment comprises any of:

visual inspection,

estimation of capsular bag volume;

labeling any residual epithelial cells to detect the presence thereof;

removing residual epithelial cells;

implanting one or more intracapsular implants;

injecting a lens forming material for molding a lens in situ,

drying the lens capsule;

alone or in any combination.

3. A method according to claim 2, wherein the implant(s) comprises one or more of capsular rings, intraocular lens, patches, valves, or injectable lens forming fluids.

4. A method according to claim 1, wherein the treatment of step c) includes introduction into the capsular bag of an agent that is capable of preventing PCO from occurring.

5. A method according to claim 1, wherein the expansion of the lens capsule (8) is accomplished with air (14), nitrogen, perfluoropropane, preferably air.

6. Method according to claim 4, wherein the active agent is a gas (14).

7. Method according to claim 4, wherein said active agent (15) is injected in form of a solution onto the inner surface of the gas-filled lens capsule (8),

8. Method according to claim 4, wherein the active agent (15) is a colored active agent

9. Method according to claim 4, wherein the active agent (15) is an active agent to which a dye has been bound.

10. Method according to claim 4, wherein the active agent (15) is in a colored solution.

11. Method according to claim 4, wherein the active agent (15), after having (irreversibly) damaged or killed the lens epithelial cells (9), is inactivated in or removed from the lens capsule (8).

12. Method according to claim 4, further comprising the step of coating the inner surface of the gas-filled lens capsule (11) with a second active agent, capable of preventing cell growth and migration onto the posterior region of the capsule for as long as possible.

13. Method according to claim 12, wherein the addition of the second active agent is subsequent to the addition of the first active agent.

14. Method according to claim 12, wherein both the first and second active agents are administered at the same time.

15. Method according to claim 12, wherein an active agent is administered which has the properties of both the first and the second agent active.

16. Method according to claim 12, wherein the viscoelastic solution (13) has the ability to eliminate the toxicity of the active agents

17. Method according to claim 1, wherein the viscoelastic solution (13) has the ability to prevent diffusion of the active agents to adjacent tissues.

18. Method according to claim 4, wherein the agent is selected from doxorubicin, methotrexate, mitomycin, daunomycin/daunorubicin, 5-fluorouracil, colchicines and taxol, and substances usable for performing a photodynamic therapy, e.g. green porphyrin

19. A method according to claim 1, wherein the medium of step b) is a selected among a gas, an aerosol, or an aqueous fluid.

20. A method according to claim 1, wherein treating the capsular bag involves surgically repairing the bag by attaching a patch of a biocompatible material

21. A method according to claim 20, wherein the patch of a biocompatible material is made of collagen.

22. A method according to claim 20, wherein the collagen is bovine collagen Type I, III or IV.

23. A method according to claim 20, wherein a fibrin sealant is introduced to secure closure

24. A method according to claim 20, wherein the patch is located over the anterior capsulotomy with an overlap of at least 1 mm.

25. A method according to claim 20, wherein the patch is located over a posterior capsulotomy with an overlap of at least 1 mm.

26. A method according to claim 1, wherein the natural crystalline lens has been surgically excised including the formation of a capsulorhexis.

27. A method according to claim 26, wherein said capsulorhexis is sealed with a plug that admits entrance into the capsular bag.

28. A method according to any of claims 1, 26 or 27 that includes injection of a lens forming fluid into the capsular bag

29. A method according to claim 2, wherein treating the capsular bag according to step c) includes inserting an applicator charged with an agent capable of preventing from PCO.

30. A method according to claim 26, wherein the method includes insertion of an intraocular lens implant comprising an optical part and haptics capable of securing said implant in the capsular bag.

31. A method according to claim 2, wherein the estimation of the volume of the capsular bag comprises:

measuring the amount of gas injected,

calculating a volume using said measured value.

32. Method according to claim 31, further comprising measuring the intraocular pressure in the capsular bag.

33. Method according to claim 31, further comprising introducing a defined amount of viscoelastic solution into the anterior chamber before injecting the gas into the capsular bag.

34. Method according to 33, wherein the volume of the anterior chamber is measured, and the amount of viscoelastic solution to be introduced into the anterior chamber is taken to be essentially equal to said volume.

35. The method as claimed in claim 31, wherein the amount of gas is estimated by monitoring the flow rate of the gas, and the time of injection.

37. Use according to claim 36, wherein said composition has a concentration within the range of 18-40 mg/ml sodium hyaluronate and the sodium hyaluronate having a molecular mass within the range of 2.5×

10⁶ to 10×

10⁶<

M>

_r,M.

38. Use according to claim 36, wherein the molecular mass of the sodium hyaluronate is within the range 2.5×

10⁶−

6×

10⁶<

M>

_r,M and the concentration of the aqueous solution is within the range of 18-35 mg/ml.

39. Use according to claim 36, wherein the molecular mass of the sodium hyaluronate is within the range 2.5×

10⁶−

5×

10⁶<

M>

_r,M and the concentration of the aqueous solution is within the range of 20-28 mg/ml.

40. Use according to claim 36, wherein the composition further comprises a compound acting as a scavenger.

41. Use according to claim 36, wherein the surgical procedures include visual inspection;

estimation of capsular bag volume;

labeling any residual epithelial cells to detect the presence thereof;

removing residual epithelial cells, implanting one or more intracapsular implants, injecting a lens forming material for molding a lens in situ, drying the lens capsule;

alone or in any combination.

36. Use of a viscoelastic aqueous composition of a polysaccharide with both dispersive and cohesive qualities for the preparation of a temporary intraocular seal capable of sealing a gas expanded capsular bag during a surgical process after lensectomy for a time sufficient to admit surgical procedures to be performed, including inspection of the capsular bag inside and/or various treatments of the capsular bag.

42. Use of a viscoelastic aqueous composition of a polysaccharide with both dispersive and cohesive qualities for the preparation of a temporary intraocular mold useful for forming a lens implant from a fluid material injected into the capsular bag by exerting a sufficient controlled adjustable localized pressure on the anterior surface of an expanded capsular bag in order to obtain a shape controlled molding of the anterior surface of a final lens implant and thereby obtain a controlled refractive outcome of treated eye.

43. Use according to claim 42, wherein said composition has a concentration within the range of 18-40 mg/ml sodium hyaluronate and the sodium hyaluronate having a molecular mass within the range of 2.5×

10⁶ to 10×

0⁶<

M>

_r,M.

44. Use according to claim 42, wherein the molecular mass of the sodium hyaluronate is within the range 2 5×

10⁶−

6×

10⁶<

M>

_r,M and the concentration of the aqueous solution is within the range of 18-35 mg/ml.

45. Use according to claim 42, wherein the molecular mass of the sodium hyaluronate is within the range 2.5×

10⁶−

5×

10⁶<

M>

_r,M and the concentration of the aqueous solution is within the range of 20-28 mg/ml.

47. The method as claimed in claim 46, wherein the lens forming fluid comprises a silicone material having a specific gravity that is greater than 1.0 and a refractive index of a natural lens that is polymerized from a plurality of siloxane monomers

48. The method of claim 46 wherein the refractive index ranges between 1.383 and 1.695.

49. The method of claim 46 wherein at least one siloxane monomer has a specific gravity greater than 1.0.

50. The method of claim 46 wherein the silicone is a terpolymer having a specific gravity of about 1.1 and a refractive index of about 1.41.

51. The method of claim 46 wherein the silicone is a copolymer having a specific gravity of about 1.1 and a refractive index of about 1.41.

52. Method according to claim 46, wherein said composition has a concentration within the range of 18-40 mg/ml sodium hyaluronate and the sodium hyaluronate having a molecular mass within the range of 2.5×

10⁶ to 10×

10⁶<

M>

_r,M

53. Method according to claim 52, wherein the molecular mass of the sodium hyaluronate is within the range 2.5×

10⁶−

6×

10⁶<

M>

_r,M and the concentration of the aqueous solution is within the range of 18-35 mg/ml.

54. Use according to claim 53, wherein the molecular mass of the sodium hyaluronate is within the range 2.5×

10⁶−

5×

10⁶<

M>

_r,M and the concentration of the aqueous solution is within the range of 20-28 mg/ml.

46. A method of performing visual correction of an eye by forming an intraocular lens in the capsular bag from which the natural crystalline lens has been surgical excised including the steps of:

injecting a predetermined amount of a lens forming fluid into the capsular bag;

locally introducing said viscoelastic material in amount sufficient to affect the shape of the anterior surface of the capsular bag;

optionally controlling the visual outcome of the eye and if necessary locally reintroducing said viscoelastic material in manner so as to approach a desired visual outcome,

forming the final lens implant.