Eye Banking in India, medical and legal perspectives

1. DR. BINESH TYAGI

2. OVERVIEW
Historical milestones
Introduction
Burden
Functions
Requirements
Procedure
Storage & preservation

3. •1906: edumund zirm 1st
successful corneal
transplantation
•1937: V P Filatow : father of modern eye
banking
•1944: Dr. R. Townley Paton established the
first eye bank in New York City.
•1953: Stocker revealed the vital role
endothelial cells play in corneal transparency.
•1955: Harris and Nordquist, published a paper
that showed endothelium maintains function at
4°C.

4. • 1961: Eye Bank Association of America was
established
• 1974: McKarey and Kaufman developed M-K
medium which allowed the excised corneo-
scleral rim to be preserved for up to 4 days at
4°C.
• 1985: Kaufman et al presented K-Sol as a
storage method viable for up to 10 days.

5. Corneal Blindness: INDIA
•2 million people- 25% of total blind in India
• 1.5 million = Unilateral
• 0.5 million = Bilateral
•New patients every year = 40,000 – 50,000
•Need = 100,000 Keratoplasty/year = 200,000 Corneas/year if
we can enhance our utilization up to 50%.

6. What is an Eye Bank ?

7. It is anonprofit communityorganization
which deals with thecollection, storage, &
distribution of corneaforthe purpose of
corneal grafting, research & supply of the
othereyetissues forthe other purposes.

8. Functions of eye bank

9. EYE BANK
ORGANIZATIO
N

10. THREE TIER ORGANIZATION
An integrated system
involving a three-tier community
eye banking pyramid based on the
infrastructure and manpower at all
levels
.
The three tiers proposed were eye
donation centres, eye bank and
eye bank training centres.

11. EBTC (eye bank training
centre)
The top tier comprises of 5 Eye banking training centers (EBTC)
responsible for
1. Tissue harvesting, processing & distribution.
2. Creating public awareness.
3. Training and skill up-gradation of eye banking personnel.

12. Eye banks
Middle tier would comprise of a strong network of 45 Eye Banks(EB)
•cater to a population of 20 million each.
•would be closely linked with 2,000 Eye Donation Centers- EDC (ratio of
1: 50 suggested)

13. EYE DONATION
CENTERS
•Publicity of the volantary donation
•Registration
•Arrangement for the collection of the eye after death
•Processing , packing , & transportation of collected eye to attached
eye bank
•would cater to a population ranging from 50,000 to 100,000.

14. Organisational structure
•EB should be under the charge of a Medical Director.
•Functions of Medical Director
• Maintains good communication with regulatory council, enucleators, eye
bank personnel, and public.
•Key managerial person- Eye bank manager.
•Three technicians and grief counsellors.
•Min 600sq feet area

15. Equipment
Mandatory
• Refrigerator with temperature
recording device
• Biological safety cabinet or
operation theatre
• Slit lamp
• Sterilization facilities
• Enucleation and corneal
excision instruments
Desirable
• Incubator
• Specular microscope
• Ultrasonic cleaner
• Ice machine
• Microbiology facilities
• Centrifuge

16. EYE BANK-SOURCES OF TISSUE
 Voluntary
 Police mortuaries
 Hospital Cornea Retrieval Program(HCRP)

17. STEPS OF EYE DONATION
1. DONOR SELECTION
2. TISSUE RETRIEVAL
3. CORNEAL EXAMINATION
4. TISSUE TRANSPORTATION
5. STORAGE OF CORNEAL TISSUE
6. DISTRIBUTION

18. DONOR SELECTION
1) AGE OF DONOR:
no influence of age on transplant outcome.
Older age : usage rate declines
Lower limit : 2 yrs to prevent myopic shift after keratoplasty

19. 2) Medical history review
• Eye banks must have consistent policies for the examination and
documentation of donor's available
• medical records,
• medical history
• cause of death
• Medications
• laboratory reports

20. Contraindications for eye
donation
I. Systemic Conditions potentially hazardous to eye bank personnel and fatal, if
transmitted:
a. HIV Seropositivity.
b. Rabies
c. Active viral hepatitis
d. Creutzfeldt-Jakob disease.
2. Other contraindications:
a. Subacute sclerosing panencephalitis
b. Progressive multifocal leukoencephalopathy
c. Reye’s syndrome
d. Death from unknown cause including unknown encephalitis
e. Congenital rubella
f. Active septicemia including endocarditis

21. II. Ocular
a. Intrinsic eye disease—retinoblastoma, active
inflammatory disease (conjunctivitis, iritis, uveitis, vitreitis,
retinitis), congenital abnormalities (keratoconus,
keratoglobus), central opacities and pterygium.
b. Prior refractive procedures—radial keratotomy scars,
lamellar inserts, laser photoablation.
c. Anterior segment surgical procedures (cataract,
glaucoma).

22. TISSUE RETRIVAL
enucleation
i.e. surgical by in -situ
removal of the whole eye corneo-scleral
excision
(globe is retained
In the orbit)

24. Enucleation

26. Corneo – scleral button
excision

28. Biomicroscopic
Examination
Whole Globe Examination
•examined as early as possible before the corneal edema
increases.
•Thawed to room temperature for the endothelium to
function and deturgesce the cornea.
•All handling of the globe should be done with sterile
instruments/cotton tipped applicators

29. CORNEOSCLERAL BUTTON EXAMINATION
1.glass vial placed in a special corneal viewing chamber
2.tissue warmed to room temperature
3.Slitlamp Biomicroscopic examination

31. Corneal Epithelium
•Epithelial microscytic oedema, defects and debris are to be
looked for.
•Epithelial oedema is indicative of poor endothelial function.
•Epithelial oedema has to be carefully differentiated from
surface irregularity of the epithelium by oblique
illumination or retroillumination techniques.

32. Corneal stroma
The corneal stroma is screened for opacities, infiltration, edema and
Descemet's folds.

33. Snail Tracks, Stress Striae
Careless
The middle and lower illustrations
show snail tracks at varying degrees
of magnification.
Careless folding of the corneal cap
during removal causes snail tracks .

34. Specular Microscopy
Cell density
Cell size, shape, uniformity, pleomorphism, and polymegathism
Presence of corneal guttata .
Evidence of any old intraocular inflammation & endothelil insult

35. Parameters obtained by the
cell analysis
• Cell density (CD)
• Coefficient of variation of cell area (CV)
• Percentage of hexagonal cells (6A)

36. Cell Density (CD)
Inversion of cell area i.e. 1,000,000 divided by average cell
area (1mm2
=1,000,000um2
)
Eg. Average cell area = 346 um2
then
CD = 1,000,000/346 = 2890 cells /mm2
Excellent : cell density of >3000 cells/mm2
Very good : cell density of 2500-3000 cells/mm2
Good : cell density of 2000-2500 cells/mm2
Fair : cell density of 1500-2000 cells/mm2
Poor : cell density of 1200-1500 cells/mm2

37. Coefficient of variation of
cell area (CV)
•CV= std deviation of cell area/ mean cell area
• Normal range : 0.20 – 0.30
• Higher the CV (wide variety in cell sizes) higher
polymegathism
• Lower the CV more stable the cornea

38. Percentage of Hexagonal
Cells (6A)
• Represents the shape factor of cells (Pleomorphism)
• Irregular cell shapes in traumatized endothelium
elongation/triangle/octagon /square
• 6A is calculated as number of hexagonal cells/number of
cells entered
• Higher the 6A – more stable the cornea
• >50% hexagonality is desirable

42. Normal Endothelial cells

44. Polymorphism and
Polymegathism

45. Folds with pleomorphism
and polymegathism

50. METHODS OF CORNEAL
PRESERVATI0N
1. Short-term storage methods
2. Intermediate-term storage
3. Long term storage

51. Eye Bank - Preservation
Media
• Short Term (48hrs) - Moist Chamber
• Intermediate Term (4 days) -
McCarey - Kaufman medium – 4 days
K - Sol medium - 7 days
Dexsol medium - 10 days
Optisol medium - 14 days
• Long term storage - Organ Culture – 35 days
Cryopreservation - 1 year

52. Short term storageShort term storage
methodsmethods
1. Moist chamber storage:
• Storage of the whole globe for short period of
time at 4 degree
• It is a closed container with cotton gauze
moistened with sterile saline
• Container is never completely filled with liquid

53. Advantages of moist chamber storageAdvantages of moist chamber storage
1.simplicity1.simplicity
2. needs little expertise & manipulation2. needs little expertise & manipulation
3.inexpensive3.inexpensive
DisadvantagesDisadvantages
1.storage time limited to 48 hrs1.storage time limited to 48 hrs
2. endothelium remains in contact with aqueous.2. endothelium remains in contact with aqueous.

54. Intermediate term storageIntermediate term storage
methodsmethods
Tissue media preservation:
Advantages:
1.provides a chemically defined & stable
environment
2.helps support & enhances metabolic activities
3.reduces the stromal swelling
4.keeps the tissue under sterile condition till use
5.provides time for EB to serologically screen the
donor for communicable diseases

55. INGREDIENTS :INGREDIENTS :
1.Dextran1.Dextran
2.Chondroitin sulphate2.Chondroitin sulphate
3.Electrolytes3.Electrolytes
4.pH buffer system4.pH buffer system
5.Antibiotics5.Antibiotics
6.Essential aminoacids6.Essential aminoacids
7.Antioxidants,ATP precursors7.Antioxidants,ATP precursors
8.Insulin8.Insulin
9.EGF9.EGF
10.A10.ANTIPROTEASES & anticollagenases& anticollagenases

56. Dextran
• Keeps preserved cornea thin
•Initially 5% of 5,00,000 mol wt dextran is used.
•In newer media 1% of 40000mol.Wt is used.
Chondroitin sulphate.
•it is akin to naturally occuring GAG in cornea.
•It is available from whale(type A),wine(typeB),shark(type c).
•High mol.wt chondroitin sulphate maintains deturegence where as
low mol.wt helps retain viability of endothelium
•Also acts as an antioxidant

57. MC CAREY KAUFMAN MEDIUM
Components
Tic 199
5% dextran
Bicarbonate buffer
Penicillin and streptomycin which was later substituted
by gentamycin in con of 50-200 micro grams per ml

58. Modified MK medium
•Waltman and plamberg
•Substituted 0.025 M hepes buffer for bicarbonate buffer
•phenol red as a pH indicator
•Osmolarity 290 milli osm/kg
•pH 7.4
•Storage period 4 days at 4 degree C.

61. Chondroitin sulphate enriched media
K-sol medium:
Storage period 7 days
Corneal storage medium:
•Minimal essential medium
•1.35 % chondroitin sulphate
•0.025 M hepes buffer
•Mercaptoethnol
•Non essential amino acids
•gentamycin

62. Dexol medium :
•Composition similar alongwith antioxidants
•Storage period – 10 days
•Optisol media :
•Described in 1991 by kaufman and associates
•Contains both dextran and chondroitin sulphate to enhance
corneal dehydration
•Storage period is 14 days
•Procell medium :
•Contains insulin ,HEGF, Vit-B12 and anti-oxidants

64. LONG-TERM STORAGE
1. Organ-culture method
2. Cryo preservation
1. Organ culture method
• Up to 35 days
• Corneoscleral button is placed in petri dish
containing 15ml of medium.

65. COMPONENTS OF ORGAN CULTURE MEDIUM
Eagle’s minimum essential medium
Earle’s salts without L-glutamine
L-glutamine
Decomplemented calf serum
1.5% chondroitin sulfate

66. 2. CRYOPRESERVATION
•can be preserved for an indefinite period of time
•Developed by CAPELLA and KAUFMAN
•Corneoscleral button is passed through a series of
solutions containing increasing concentraions of
DIMETHYL SULFOXIDE(DMSO) upto 7.5%
•It acts as membrane stabilizer
•frozen at a controlled rate upto -80 deg C
•subsequently stored at -180 deg C

67. Advantages of cryopreservation
•emergency situations like corneal trauma and perforation
•for performing bacteriological studies on donor tissue and HLA
compatability studies
•Disadvantages
•Needs expensive equipment and highly trained persons

68. Other uses:
Donated Sclera can be used for glaucoma , oculoplastic and retinal
surgeries
Human amniotic membrane can be used for ocular surface procedures
Fair and equitable distribution of transplantable tissues to corneal
surgeons acco to waiting list.

69. LEGAL ASPECTS IN
INDIA
Under the Transplantation of Human Organs Act, 1994 (THOA)
1. The qualification of doctors permitted to perform enucleation (surgical
eye removal) has been reduced from MS (Ophth.) to MBBS.
2. Eye donation in India is always decided by the donor’s surviving
relatives and not by the actual donor.
3. Enucleating doctors always have to legally obtain a written consent
from the relatives of the deceased before they actually remove the eyes.

70. Don't Burn or Bury
Your Eyes.....
Help Others See Our
Beautiful World Too!