Elsevier

Ophthalmology

Volume 105, Issue 10, 1 October 1998, Pages 1855-1865
Ophthalmology

Ten-year postoperative results of penetrating keratoplasty

Presented in part at the Association for Research in Vision and Ophthalmology annual meeting, Fort Lauderdale, Florida, May 15, 1997.
https://doi.org/10.1016/S0161-6420(98)91030-2Get rights and content

Abstract

Objective

To investigate the changes in central corneal endothelial cells and corneal thickness in transplanted corneas from 5 to 10 years after grafting. This study also aimed to investigate the development of glaucoma, graft rejection, and graft failure during the first 10 postoperative years.

Design/participants

Longitudinal cohort study of 500 consecutive penetrating keratoplasties by 1 surgeon. Patients were asked to return for follow-up examinations at 2 months and at 1, 3, 5, and 10 years after grafting. The authors excluded eyes regrafted during the study and the fellow eyes of bilateral cases, leaving 394 grafts in 394 patients for analysis.

Intervention

Penetrating keratoplasty was performed.

Main outcome measures

Using specular microscopy, the authors measured endothelial cell density, coefficient of variation of cell area, percentage of hexagonal cells, and corneal thickness. The authors performed clinical examinations to determine graft rejection or failure and the development of glaucoma.

Results

By 10 years postkeratoplasty, 80 of the 394 patients had died and 68 grafts had failed. Of the remaining 246 patients, 119 (48%) returned for their 10-year examinations. For the 72 patients who returned for all of the scheduled postoperative visits and had no rejection episodes, reoperations, or failure, endothelial cell loss from preoperative donor levels at 10 years was 67 ± 18% (mean ± standard deviation), endothelial cell density was 958 ± 471 cells/mm2, coefficient of variation was 0.32 ± 0.11, hexagonal cells were 56 ± 12%, and corneal thickness was 0.58 ± 0.05 mm. The 5- to 10-year changes for all these values were significant (P ≤ 0.004). The mean rate of late endothelial cell loss from 5 to 10 years postkeratoplasty was 4.2% per year. Eyes that were aphakic after grafting had the lowest endothelial cell loss (57 ± 24%) and the lowest interval cell loss from 5 to 10 years postkeratoplasty (4 ± 19%). Eyes that were phakic had the highest endothelial cell loss (73 ± 8%) and 5- to 10-year-interval cell loss (17 ± 31%). Eyes with posterior chamber lenses had a greater endothelial cell loss (71 ± 9%) than did eyes with anterior chamber lenses (51 ± 25%, P = 0.03). The 10-year cumulative risk of glaucoma, rejection, or failure was 21%, 21%, and 22%, respectively. Late endothelial failure became the major cause for graft failure, accounting for 9 of the 11 failures after 5 postoperative years.

Conclusions

From 5 to 10 years after penetrating keratoplasty, the annual rate of endothelial cell loss was seven times the normal rate. The endothelial cell loss, pleomorphism, polymegethism, and corneal thickness increased significantly during this time, indicating continued endothelial instability and dysfunction, resulting in an increasing rate of late endothelial failure.

Section snippets

Methods

Enrollment consists of 500 consecutive patients who had penetrating keratoplasty between 1976 and 1986 by 1 surgeon (WMB). To make each graft an independent observation, 36 repeat grafts of eyes that previously were grafted in the study and 70 fellow eyes of bilateral cases were excluded. This left 394 grafts in 394 patients. There were 143 males and 251 females; the age at keratoplasty ranged from 3 to 94 years (62 ± 20 years, mean ± standard deviation). The distribution of preoperative

Results

One hundred nineteen patients returned for their 10-year postoperative examinations. The mean postoperative time was 10 years (range, 8.1–11.3 years). By the 10-year examination, 68 grafts were known to have failed and 80 patients were known to have died. One hundred nineteen patients represent 48% of the clear grafts available for follow-up (Table 3).

Of the 119 specular microscopic examinations performed at 10 years, 2 photographs produced images that were not sufficiently clear to allow for

Discussion

Several points need to be made regarding our data evaluation. First, when a large number of comparisons are made, the chance of reporting a type I error (a false-positive) is high. Therefore, more confidence should be placed in differences of higher statistical significance (i.e., those with P ≤ 0.01). Second, the results of nonrandomized studies such as this one are not as powerful or predictive as the results of randomized controlled studies. Third, when comparing the groups with regard to

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    Supported in part by National Institutes of Health research grant EY 02037; an unrestricted grant from Research to Prevent Blindness, Inc., New York, New York; and the Mayo Foundation, Rochester, Minnesota.

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