Efficacy And Safety Of Penetrating Keratoplasty With Foreign Donated Corneas: A Pattern Of Prospective Clinical Tiral

Objective:To overcome the shortage of donor corneas, we are currently using donor corneassupplied by foreign international eye bank. However, the efficacy and safety of usingforeign donor corneas has not been investigated. This case-controlled study wasconducted to show the efficacy and safety of penetrating keratoplasty using corneasfrom foreign donors for different corneal disorders.Method:In a total of108cases (108eyes) with different corneal disorders who underwentpenetrating keratoplasty in Northern Hospital from February of2011to December of2012were enrolled in this prospective study. The patients who were matched wererandomized into2groups of foreign group (54eyes) and domestic group (54eyes). Thetwo groups were divided into infective subgroup (29eyes) and non-infective subgroup(25eyes) respectively. The BCVA, complications, postoperative survival state of thegrafts were compared between2groups and subgroups. The incidence of clear grafts inthe two groups was compared using the Kaplan-Meyer analysis with the log-rank testfor statistical significance. Chi-square and t test were used to compare incidencebetween domestic and foreign groups. P values of less than0.05were considered to bestatistically significant.Results:There were no significant differences in the ratio of recipient sex and age,distribution of initial diseases, BCVA and neovascularization degree of grafts betweenthe two groups. The mean age of the donors in the foreign (66.3±8.7years) anddomestic (27.8±11.3years) groups was significantly different (t=14.021, P=0.000). Themean P-O (preservation-operation) time was significantly longer in the foreign group(125.4±36.7hours) than in the domestic group (23.6±8.9hours)(t=14.007, P=0.000). The endothelial cell density of the grafts was lower in the foreign group on3rd、6thand12thpostoperatively (1309±219vs.1860±265cell/mm~2;1098±221vs.1573±216cell/mm~2;1025±147vs.1508±192cell/mm~2)(P <0.05). The rates of effective treatmentof infective keratitis in the two groups were89.7%and86.2%respectively, which werenot significantly different (χ~2=0.16, P=0.687). The BCVA (t=0.057, P=0.955) andneovascularization degree (u=0.24, P=0.811) were not significantly different betweenthe two groups at the end of the follow-up period. But there were better postoperativeBCVA and lower neovascularization degree of the grafts in the non-infective subgroupsof the two groups (P<0.05). The mean survival times of the grafts in the two groupswere534.671±36.317and506.755±38.954days respectively. The incidence of cleargrafts was not significantly different between the two groups at the end of the follow-upperiod (χ~2=0.179, P=0.672, log-rank test). The rates of primary graft failure (χ~2=2.04,P=0.153), immune rejection of the grafts (χ~2=0.98, P=0.322), secondary glaucoma(χ~2=0.20, P=0.653) and postoperative infections (χ~2=1.01, P=0.315) were notsignificantly different in the foreign and domestic groups. But the abnormalities ofcorneal epithelium were significantly different between the two groups (χ~2=4.74,P=0.03).Conclusions:The study results indicate that the foreign donor corneas are as safe and effective asthe domestic ones in penetrating keratoplasty.