Background: Fuchs endothelial dystrophy (FED), first described by Ernst Fuchsis in 1910, is a condition in which there is premature degeneration of corneal endothelial cells. When the number of endothelial cells is reduced to a significant degree fluid begins to accumulate within the cornea. As a result the cornea loses its transparency and the individual suffers a reduction in vision. The only successful surgical treatment for this condition is replacement of part or all of the cornea with healthy tissue from a cadaveric donor. The established procedure, penetrating keratoplasty (PKP), has been used for many years and its safety and efficacy are well known. Endothelial keratoplasty (EK) is a relatively new surgical procedure and the safety and efficacy relative to PKP are unknown.
Objectives: The objective of this review is to collate information on the benefits and complications related to two surgical methods (PKP and EK) of replacing the diseased endothelial layer of the cornea with a healthy layer in people with FED.
Search strategy: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2011, Issue 2), MEDLINE (January 1950 to February 2011), EMBASE (January 1980 to February 2011), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to February 2011), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 6 February 2011.
Selection criteria: We included all randomised controlled trials (RCTs) comparing EK versus PKP for people (of any age and gender) who had been clinically diagnosed with FED. When assessing the primary and secondary outcome measures, only RCTs were included in the analysis. As per our protocol a description of data from non-randomised comparative studies is also reported. As RCTs may not detect differences in frequency of adverse events, when assessing these we included data from cohort studies with more than 50 participants and a follow-up of up to five years.
Data collection and analysis: Two authors independently assessed trial quality and extracted data.
Main results: The electronic searches identified one RCT, five non-randomised comparative studies and 34 cohort studies with a sample size of over 50 participants for inclusion. The RCT was conducted in the USA and included 28 eyes of 25 participants with FED. Although this is a very good RCT, there may be potential for bias due to lack of masking of assessors and possible selective reporting not being clearly reported. In this RCT, comparing EK versus PKP, best corrected visual acuity (BCVA) was similar at 24 months (PKP 0.20 ± 0.20 logMAR; EK 0.34 ± 0.35 logMAR; P = 0.23) and higher order aberrations (HOAs) (deviations of the performance of an optical system from the predictions of paraxial optics) were lower with EK. No other data were reported by the trial. Based on data obtained from both non-randomised comparative studies and individual cohort studies the endothelial rejection rate was between 5.3% and 23.2% for PKP and 2% and 4% for EK. However the mean follow-up duration in the EK cohort studies was noticeably shorter. The rate of EK graft dislocation requiring repositioning ranged from 3% to 63%, with the majority of studies having a rate of < 10%.
Authors' conclusions: There is no high quality evidence that EK is superior to PKP in the treatment of FED considering the studies that satisfied our primary and secondary outcome measures. One RCT demonstrated that HOAs are lower following EK and some lower quality evidence suggests that endothelial rejection episodes may be less with EK. These findings should be interpreted with caution as they are based on data with risk of biases. Further RCTs of visual and refractive outcomes needs to be performed in this field, comparing EK to PKP, with a larger sample size and at least five years of follow up. To avoid bias due to a surgeon's learning curve, procedures should be performed by experienced surgeons only. Quality of life and vision should also be evaluated. The risk of endothelial rejection will be difficult to address in the context of a RCT because of power considerations but large non-randomised comparative case series and corneal graft registry outcome data will be useful in this regard.