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Endothelial morphometric measures to predict endothelial graft failure after penetrating keratoplasty.

ABSTRACT: Endothelial morphometric measures have potential value in predicting graft failure after penetrating keratoplasty.To determine whether preoperative and/or postoperative central morphometric measures (endothelial cell density [ECD], coefficient of variation [CV], and percentage of hexagonality [HEX]) and their postoperative changes are predictive of graft failure caused by endothelial decompensation after penetrating keratoplasty to treat a moderate-risk condition, principally Fuchs dystrophy or pseudophakic corneal edema.In a subset of Cornea Donor Study participants with graft failure, a central reading center determined preoperative and postoperative ECD, CV, and HEX from available central endothelial specular images.Cornea Image Analysis Reading Center of the Specular Microscopy Ancillary Study.Eighteen patients with graft failure due to endothelial decompensation and 54 individuals matched for most donor and recipient measures at baseline whose grafts did not fail.Change in ECD, CV, and HEX values.Preoperative ECD was not associated with graft failure (P = .43); however, a lower ECD at 6 months was predictive of subsequent failure (P = .004). Coefficient of variation at 6 months was not associated with graft failure in univariate (P = .91) or multivariate (P = .79) analyses. We found a suggestive trend of higher graft failure with lower HEX values at 6 months (P = .02) but not at the established statistical significance (P < .01). The most recent CV or HEX values, as time-dependent variables, were not associated with graft failure (P = .26 and P = .81, respectively). Endothelial cell density values decreased during follow-up, whereas CV and HEX appear to fluctuate without an apparent trend.Endothelial cell density at 6 months after penetrating keratoplasty is predictive of graft failure, whereas CV and HEX appear to fluctuate postoperatively, possibly indicating an unstable endothelial population in clear and failing grafts.clinicaltrials.gov Identifier: NCT00006411.

SUBMITTER: Benetz BA

PROVIDER: S-EPMC4179110 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo examine the long-term effect of donor diabetes history on graft failure and endothelial cell density (ECD) after penetrating keratoplasty (PK) in the Cornea Donor Study.DesignMulticenter, prospective, double-masked, controlled clinical trial.ParticipantsOne thousand ninety subjects undergoing PK for a moderate risk condition, principally Fuchs' dystrophy or pseudophakic or aphakic corneal edema, were enrolled by 105 surgeons from 80 clinical sites in the United States.MethodsCorneas from donors 12 to 75 years of age were assigned by 43 eye banks to participants without respect to recipient factors. Donor and recipient diabetes status was determined from existing medical records. Images of the central endothelium were obtained before surgery (baseline) and at intervals for 10 years after surgery and were analyzed by a central image analysis reading center to determine ECD.Main outcome measuresTime to graft failure (regraft or cloudy cornea for 3 consecutive months) and ECD.ResultsThere was no statistically significant association of donor diabetes history with 10-year graft failure, baseline ECD, 10-year ECD, or ECD values longitudinally over time in unadjusted analyses, nor after adjusting for donor age and other significant covariates. The 10-year graft failure rate was 23% in the 199 patients receiving a cornea from a donor with diabetes versus 26% in the 891 patients receiving a cornea from a donor without diabetes (95% confidence interval for the difference, -10% to 6%; unadjusted P=0.60). Baseline ECD (P=0.71), 10-year ECD (P>0.99), and changes in ECD over 10 years (P=0.86) were similar comparing donor groups with and without diabetes.ConclusionsThe study results do not suggest an association between donor diabetes and PK outcome. However, the assessment of donor diabetes was imprecise and based on historical data only. The increasing frequency of diabetes in the aging population in the United States affects the donor pool. Thus, the impact of donor diabetes on long-term endothelial health after PK or endothelial keratoplasty, or both, warrants further study with more precise measures of diabetes and its complications.

Project description:PurposeTo compare the amount of myopia induced by same-size donor-to-host penetrating keratoplasty with that of the amount of myopia induced by over-sized donor-to-host penetrating keratoplasty.SettingTertiary referral academic center.DesignRetrospective cohort study.MethodsCharts from patients who underwent penetrating keratoplasty by the same technique at Bascom Palmer Eye Institute between Nov 1, 2002, and January 1, 2006, were reviewed. The patients underwent optical penetrating keratoplasty using 12 interrupted 10-0 nylon sutures and a 12-bite continuous 10-0 nylon suture by a single surgeon (R.K.F.). The surgical technique used would be considered standard of care at most institutions. The Institutional Review Board, University of Miami Human Subjects Research Office, approved the study protocol. The donor graft was over-sized by 0.25mm in eyes when the intended final refractive target was greater than -1.00 diopters spherical equivalent (SE). The same-size donor graft was used when the intended final refractive target was less than -1.00 diopters SE. The selection of donor graft size was entirely based upon clinical parameters, meaning that the intended final refractive target was determined per each patient's fellow eye refraction, with the intention of reducing anisometropia. All patients received postoperative refraction and corneal topography. These measurements were performed at 6-8 weeks when the initial removal of sutures commenced, then at 6 months, then after completion of selective suture removal, then again at 12 months.ResultsAt 12 months, the over-sized group resulted in -1.35 diopters (SD = 2.25) SE of refraction, and the same-size group resulted in -0.14 diopters (SD = 2.42) SE. This approached statistical significance (p = 0.052) in comparison to -1.00 diopters spherical equivalent.ConclusionsUsing a donor graft that is over-sized by 0.25mm results in refraction of -1.00 diopters SE or more of myopia. Using a same-size donor-graft results in refraction of less than -1.00 diopters SE. Therefore, careful graft-size selection can result in a more favorable clinical outcome-namely, reduction in anisometropia-in patients undergoing penetrating keratoplasty.

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Endothelial morphometric measures to predict endothelial graft failure after penetrating keratoplasty.

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