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

Benetz Beth Ann BA Lass Jonathan H JH Gal Robin L RL Sugar Alan A Menegay Harry H Dontchev Mariya M Kollman Craig C Beck Roy W RW Mannis Mark J MJ Holland Edward J EJ Gorovoy Mark M Hannush Sadeer B SB Bokosky John E JE Caudill James W JW

JAMA ophthalmology 20130501 5

<h4>Importance</h4>Endothelial morphometric measures have potential value in predicting graft failure after penetrating keratoplasty.<h4>Objective</h4>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 condi ...[more]

PMID: 23493999

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Project description:To 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.Multicenter, prospective, double-masked, controlled clinical trial.One 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.Corneas 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.Time to graft failure (regraft or cloudy cornea for 3 consecutive months) and ECD.There 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.The 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.

Project description:ObjectiveTo determine whether the 10-year success rate of penetrating keratoplasty for corneal endothelial disorders is associated with donor age.DesignMulticenter, prospective, double-masked clinical trial.ParticipantsA total of 1090 participants undergoing penetrating keratoplasty at 80 sites for Fuchs' dystrophy (62%), pseudophakic/aphakic corneal edema (34%), or another corneal endothelial disorder (4%) and followed for up to 12 years.MethodsForty-three eye banks provided corneas from donors aged 12 to 75 years, using a randomized approach to assign donor corneas to study participants without respect to recipient factors. Surgery and postoperative care were performed according to the surgeons' usual routines.Main outcome measuresGraft failure defined as a regraft or, in the absence of a regraft, a cloudy cornea that was sufficiently opaque to compromise vision for 3 consecutive months.ResultsIn the primary analysis, the 10-year success rate was 77% for 707 corneas from donors aged 12 to 65 years compared with 71% for 383 donors aged 66 to 75 years (difference, +6%; 95% confidence interval, -1 to +12; P = 0.11). When analyzed as a continuous variable, higher donor age was associated with lower graft success beyond the first 5 years (P<0.001). Exploring this association further, we observed that the 10-year success rate was relatively constant for donors aged 34 to 71 years (75%). The success rate was higher for 80 donors aged 12 to 33 years (96%) and lower for 130 donors aged 72 to 75 years (62%). The relative decrease in the success rate with donor ages 72 to 75 years was not observed until after year 6.ConclusionsAlthough the primary analysis did not show a significant difference in 10-year success rates comparing donor ages 12 to 65 years and 66 to 75 years, there was evidence of a donor age effect at the extremes of the age range. Because we observed a fairly constant 10-year success rate for donors aged 34 to 71 years, which account for approximately 75% of corneas in the United States available for transplant, the Cornea Donor Study results indicate that donor age is not an important factor in most penetrating keratoplasties for endothelial disease.

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

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

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