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Table of Contents
ORIGINAL ARTICLE
Year : 2021  |  Volume : 15  |  Issue : 3  |  Page : 223-226

Comparison of donor corneas obtained from hospital cornea retrieval program and voluntary eye donation in South India - A prospective study


Department of Cornea and Refractive Services, Aravind Eye Hospital, Madurai, Tamil Nadu, India

Date of Submission29-Jul-2020
Date of Decision05-Apr-2021
Date of Acceptance28-Apr-2021
Date of Web Publication30-Sep-2021

Correspondence Address:
Dr. Naveen Radhakrishnan
Consultant, Department of Cornea and Refractive Surgery, Aravind Eye Hospital, 1, Anna Nagar, Madurai - 625020, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijot.ijot_85_20

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  Abstract 

Background: The aim of this study was to compare the donor characteristics, quality of tissues, and utilization rate of corneas collected through Hospital cornea retrieval program (HCRP) and voluntary eye donation (VED). Methods: A prospective nonrandomized comparative study of all consecutive donor corneas collected through HCRP and VED during December 2015 to November 2016 was performed. Details of the donor such as age, sex, cause of death, need for medicolegal clearance, death to enucleation time, slit-lamp grading, specular microscopy, and tissue utilization were documented. Results: Nine hundred and eighty-five eyes of 493 donors were included in the study, of which 606 (61.5%) eyes belonged to HCRP and 379 (38.5%) eyes in VED. HCRP donors were significantly younger (HCRP: 43.87 ± 19 years; VED: 72.8 ± 13 years; P < 0.001). Males were more common in HCRP (HCRP: 236, 77.6%; VED: 99, 52.2%; P < 0.001). The most common cause of death was road traffic accident (132, 43.6%) in HCRP and cardiovascular disease (93, 49%) in VED. 73.3% (222) of HCRP donors needed medicolegal clearance. Phakic donor eyes were significantly higher in HCRP (HCRP: 561, 92.6%; VED: 184, 48.6%; P < 0.001). Specular microscopy was possible in 396 (65.3%) eyes of HCRP and 129 (34%) eyes of VED. The mean endothelial cell density was 2931 ± 431.1 in HCRP and 2668.6 ± 381.1 in VED. The tissue utilization rate was significantly higher in HCRP (HCRP: 481, 79.4%; VED: 201, 53%; P < 0.001). Eighty-two percent of endothelial keratoplasty, 78.5% of optical penetrating keratoplasty, and 58% of therapeutic keratoplasty were from HCRP donors. Conclusion: Donor corneas collected through HCRP have higher tissue utilization.

Keywords: Hospital cornea retrieval program, keratoplasty, voluntary eye donation


How to cite this article:
Rashme VL, Radhakrishnan N, Das M, Srinivasan M, Prajna N V. Comparison of donor corneas obtained from hospital cornea retrieval program and voluntary eye donation in South India - A prospective study. Indian J Transplant 2021;15:223-6

How to cite this URL:
Rashme VL, Radhakrishnan N, Das M, Srinivasan M, Prajna N V. Comparison of donor corneas obtained from hospital cornea retrieval program and voluntary eye donation in South India - A prospective study. Indian J Transplant [serial online] 2021 [cited 2021 Nov 29];15:223-6. Available from: https://www.ijtonline.in/text.asp?2021/15/3/223/327399


  Introduction Top


Corneal blindness is the fourth leading cause of global blindness and the second leading cause in developing countries such as India and African countries.[1] The National Prevention of Corneal Blindness Program (NPCB) of India estimated 122,000 bilateral corneal blind persons in the country, of whom 60,000 can be rehabilitated with keratoplasty.[2] Although the annual collection of corneas tripled over the past decade in India, the utilization rate is still low at 40%–45%.[3] NPCB partners reportedly collected 50,000 corneas every year, and it still falls short of the required corneas significantly to wipe out the backlog. In order to improve the donor collection to meet the existing needs, we have to achieve 1.5%–2% of eye donation rate from eligible donors in a country with a crude death rate of 7.33% (2017).[3],[4]

In India, eye donation is performed through two methods: the voluntary eye donation (VED) and the hospital cornea retrieval program (HCRP). In VED, the family members of the deceased inform the eye bank directly or through the members of nongovernmental organizations. The eye bank team reaches the site which is most often the home of the deceased and retrieves the eye. In HCRP, a trained grief counselor who is stationed at the general hospital approaches the family of the deceased in the hospital and motivates them to consider eye donation and give permission on behalf of their loved one.[5] The Eye Bank Association of India (EBAI) reported the utilization rate of overall Indian eye banks to be 38% with VED donor tissues and 72% with HCRP donor tissues considering HCRP to be a highly focused and efficient approach that minimizes the resources and the donors required.[6] However, the literature comparing the characteristics of the donor corneas collected through both the systems and its relevance on improving the eye bank activities is scarce. The aim of this study is to compare the donor characteristics, quality of the tissues, and the utilization rate of the corneas collected through VED and HCRP from rural South India.


  Methods Top


A prospective nonrandomized comparative study of the donor corneas collected through VED and HCRP was performed during the study period from December 2015 to November 2016. The study adhered to the tenets of the Declaration of Helsinki and is approved by the institutional review board (IRB201500217).

All consecutive donor eyes collected during the study period were included in the study. The eyes collected from hospitals through the grief counselors were included in the HCRP group, and the donor eyes collected through voluntary telephonic calls were included in the VED group. The eyes were enucleated in toto and stored in moist chamber during the transport to the eye bank. After the enucleated eyeball reached the eye bank, it was examined by the cornea consultant, and based on the quality of the tissue, it was graded into excellent, very good, good, fair, and not suitable for surgery. The eyeball which was graded as excellent or very good or good or fair was excised under aseptic precautions in the eye bank under laminar airflow.

An incision was made through the sclera, 2–3 mm from the limbus, and 4–5 mm in length into the suprachoroidal space. Using the right and left Castroviejo corneal scissors, the sclera was cut 360° evenly with the blades of the scissors. With the sterile toothed forceps, the cornea was held by its scleral rim, and with the iris forceps, iris was gently pealed off and the cornea was kept inside the storage medium with it's epithelial side touching the base of the storage vial. The corneoscleral button was stored in Cornisol medium (Aurolab, India) after the blood sample had been tested for the standard serology tests. Specular microscopy was performed for the excised corneoscleral buttons in the Cornisol medium. The eyeball that was categorized as not suitable for surgery was used for wet-laboratory training and research purpose. Details of the donor such as age, sex, cause of death, need for medicolegal clearance, death to enucleation time, slit-lamp grading, specular microscopy, and tissue utilization were documented.

Mean (standard deviation) and frequency (percentage) were used for continuous and categorical variables, respectively. Fisher's exact test or Chi-square test was used to assess the difference between the categorical variables. Student's t-test or Mann–Whitney U-test was used to test the mean difference between the two continuous variables. P < 0.05 was considered as statistically significant. All statistical analysis was done by statistical software STATA VERSION 11.0, StataCorp LLC, Lakeway drive, Texas, USA.

Statistical analysis

Mean (standard deviation) and frequency (percentage) were used for continuous and categorical variables, respectively. Fisher's exact test or Chi-square test was used to assess the difference between the categorical variables. Student's t-test or Mann–Whitney U-test was used to test the mean difference between the two continuous variables. P < 0.05 was considered as statistically significant. All statistical analysis was done by statistical software STATA 11.0. StataCorp LLC, Lakeway drive, Texas, USA.

Patient consent

The patient consent has been taken for participation in the study and for publication of clinical details and images. Patients understand that the names and initials would not be published, and all standard protocols will be followed to conceal their identity.

Ethics statement

IRB Number: IRB201500217, Institute Ethics Committee, Aravind Medical Research Foundation. All protocols were followed as per Declaration of Helsinki. The procedure was carried out in accordance with the Declaration of Helsinki and International Council for Harmonization-Good Clinical Practice (ICH-GCP).


  Results Top


Nine hundred and eighty-five eyes of 493 donors (one donor in VED was monocular) were included during the study period. Six hundred and six (61.5%) eyes of 303 donors belonged to HCRP, and 379 (38.5%) eyes of 190 donors belonged to VED [Table 1].
Table 1: Donor characteristics and utilization of donor eyes of hospital cornea retrieval program and voluntary eye donation group

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Donor characteristics

The mean age of the donors was significantly less (P < 0.001, Student's t-test) in the HCRP group (43.87 ± 19 years) compared to the VED group (72.8 ± 13 years). Males were significantly more common (P < 0.001, Fisher's exact test) in the HCRP group (236, 77.6%) compared to the VED group (99, 52.2%). The most common cause of death in HCRP was road traffic accident in 132 (43.6%) donors followed by poisoning in 57 (18.8%). A significant proportion of the poisoning was due to organophosphorus compounds (41, 13.3%). Whereas in the VED group, the most common cause of death was cardiovascular disease in 93 (49%) donors followed by respiratory failure in 47 (24.7%) donors. Of the 303 HCRP donors, 222 (73.3%) needed medicolegal clearance from local police and forensic department before enucleation. In the VED group, medicolegal clearance was needed in two donors, due to the cause of death, namely road traffic accident. The mean death to enucleation time was 201.30 ± 95.93 min in the HCRP group and 184.84 ± 78 min in the VED group (P = 0.058, Man–Whitney U-test).

Quality of the tissue

Donor eyes with phakic status were significantly higher (P < 0.001, Chi-square test) in the HCRP group (561, 92.6%) compared to the VED group (184, 48.6%). Specular microscopy was possible in 396 (65.3%) eyes of HCRP and 129 (34%) eyes of VED. Of the eyes with measurable endothelial count, the mean endothelial cell density was 2931.48 ± 431.1 in the HCRP group compared to 2668.6 ± 381.1 in the VED group. Slit-lamp evaluation of the HCRP donor eyes revealed 26 (4.3%) eyes in excellent grade, 109 (18.0%) in very good grade, 300 (49.5%) in good grade, 88 (14.5%) in fair grade, and 83 (13.7%) were not suitable for surgery. Whereas in the VED group, 9 (2.4%) eyes were in excellent grade, 36 (9.5%) in very good grade, 138 (36.4%) in good grade, 91 (24.0%) in fair grade, and 105 (27.7%) were not suitable for surgery.

Utilization

Of the 606 eyes in HCRP, 481 (79.4%) were utilized for keratoplasty, of which 285 (47%) eyes were utilized for optical penetrating keratoplasty, 65 (10.7%) eyes were utilized for endothelial keratoplasty, 12 (1.6%) were utilized for deep anterior lamellar keratoplasty (DALK), 121 (19.9%) eyes were utilized for therapeutic keratoplasty, and 125 (20.6%) eyes could not be utilized due to poor tissue quality. Of the 379 eyes in the VED group, 201 (53%) were utilized for keratoplasty and 178 (47%) were not suitable for surgery. Of these 201 eyes, 78 (20.5%) were utilized for optical penetrating keratoplasty, 14 (3.7%) were utilized for endothelial keratoplasty, 12 (3.2%) were utilized for DALK, and 87 (22.9%) was used for therapeutic keratoplasty. The HCRP group had a significantly higher tissue utilization compared to the VED group (P < 0.001, Chi-square test). Eighty two percent of our endothelial keratoplasty, 78.5% of our optical penetrating keratoplasty, and 58% of our therapeutic keratoplasty were from HCRP donors.


  Discussion Top


India had been making great strides in addressing blindness due to cataract but lags in treating corneal blindness due to lack of good-quality corneal tissue.[2] Increase in awareness campaigns and eye bank development efforts in recent years have shown only modest success with a 10% annual increase in transplant surgeries in the last 10 years. This growth rate is not sufficient to address the estimated 122,000 corneal blind in India. We need to increase this growth rate by 20% to reach the target of 100,000 transplants per year.[7],[8] Tissue utilization rate is slowly climbing to 40%, which is still low compared to Western countries. Major factors for low utilization are lack of screening of donors in voluntary donation and limited training of staff.[2] Many eye banks in India rely primarily on voluntary donations, and this contributes to the low utilization rates overall. The transplant surgery rate per million population is 15 in India, with a cataract surgery rate of over 4000.[6] Even among centers with increased cornea utilization, the increase was noted to be due to an increase in the utilization of nonoptical grade tissues with therapeutic keratoplasty in India. The most common indication for keratoplasty is still acute infective keratitis and corneal melts associated with them. Therapeutic keratoplasty still forms more than 50% of the total keratoplasty in India compared to the USA, wherein endothelial keratoplasty was the most common keratoplasty performed.[9] The EBAI reported an overall 72% utilization rate with HCRP donor eyes compared to 38% utilization in VED donors.[6] HCRP is possible in India, given proper training and professional program structure.

It is important to note that the donors of HCRP were significantly younger than VED and died mostly due to unnatural causes such as road traffic accidents or poisoning. It is well known that the endothelial cell density, a surrogate marker for the endothelial health and quality of the corneal tissue, decreases with age.[10] The percentage of phakic eyes was significantly more in the HCRP group. Kwon et al. reported that age, past history of cataract surgery, and diabetes mellitus were found to be the greatest risk factors for inadequate quality of the donor tissues.[11] However, among the patients who underwent penetrating keratoplasty, the 5-year graft survival rate was not associated with donor age.[12] Age-matched gender was not associated with low endothelial cell density.[10]

Eighty percent of the tissues in HCRP were utilized for keratoplasty and more than 60% of them were utilized for optical indications. Whereas, only 50% of VED tissues were utilized for keratoplasty and the majority of them were utilized for therapeutic keratoplasty. Four-fifths of our endothelial keratoplasty and optical penetrating keratoplasty and two-thirds of our therapeutic keratoplasty were from HCRP donor tissues. One-third of the therapeutic keratoplasty is from VED. It is interesting to note that the death to enucleation time was more in the HCRP than the VED group, mainly due to the medicolegal formalities. A cordial relationship between the eye bank and the hospitals involved is essential for the smooth functioning of HCRP.


  Conclusion Top


HCRP is highly efficient with high utilization of good quality tissues. It can bridge the demand-supply gap that currently exists for a good-quality corneal tissue. Yet, we cannot undermine the importance of VED in a country where the need for donor cornea is still unmet.

Limitations

As the study is from South India rural region, results may not be generalizable to the entire country

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Pineda R. Corneal transplantation in the developing world: Lessons learned and meeting the challenge. Cornea 2015;34 Suppl 10:S35-40.  Back to cited text no. 1
    
2.
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Sharma N, Agrawal N, Maharana PK, Agarwal T, Vanathi M, Vajpayee RB. Comparison of hospital cornea retrieval and voluntary eye donation program in eye banking. Eye Contact Lens 2018;44 Suppl 1:S54-8.  Back to cited text no. 4
    
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Krishnaiah S, Kovai V, Nutheti R, Shamanna BR, Thomas R, Rao GN. Awareness of eye donation in the rural population of India. Indian J Ophthalmol 2004;52:73-8.  Back to cited text no. 5
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Sangwan VA, Gopinathan U, Garg P, Rao GN. Eye banking in India – A road ahead. J Int Med Sci Acad 2010;23:197-200.  Back to cited text no. 8
    
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Kwon JW, Cho KJ, Kim HK, Lee JK, Gore PK, McCartney MD, et al. Analyses of factors affecting endothelial cell density in an eye bank corneal donor database. Cornea 2016;35:1206-10.  Back to cited text no. 11
    
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Wakefield MJ, Armitage WJ, Jones MN, Kaye SB, Larkin DF, Tole D, et al. The impact of donor age and endothelial cell density on graft survival following penetrating keratoplasty. Br J Ophthalmol 2016;100:986-9.  Back to cited text no. 12
    



 
 
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