Wilhelmina J. Rijneveld

Endothelial cell loss and visual outcome of deep anterior lamellar keratoplasty versus penetrating keratoplasty: a randomized multicenter clinical trial

OBJECTIVE To compare endothelial cell (EC) loss, visual and refractive outcomes, and complications after deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty (PK). DESIGN Randomized, multicenter clinical trial. PARTICIPANTS Fifty-six eyes of 56 patients with a corneal stromal pathology not affecting the endothelium were randomized to DALK or PK. METHODS The DALK procedure was performed according to Anwars big-bubble technique. Patients underwent an ophthalmic examination preoperatively and 3, 6, and 12 months postoperatively. MAIN OUTCOME MEASURES Endothelial cell loss, refractive and topographic astigmatism, spherical equivalent, uncorrected visual acuity, and best spectacle-corrected visual acuity (BSCVA) were measured, and complications were recorded. RESULTS Endothelial cell loss was significantly higher after PK compared with DALK procedures performed without perforation of Descemets membrane (12 months: 27.7% ± 11.1% vs. 12.9% ± 17.6%). The BSCVA was significantly better in the PK group at 3 and 6 months after surgery but was not significantly different 12 months after surgery (0.39 ± 0.3 logarithm of the minimum angle of resolution [logMAR] in DALK and 0.31 ± 0.3 logMAR in PK). At 12 months postoperatively, refractive and topographic astigmatism in the DALK and PK groups were -3.37 ± 2.3 diopters (D) and -3.76 ± 2.1 D (P = 0.53), and 3.57 ± 2.3 D and 4.16 ± 2.0 D (P = 0.34), respectively. (Micro)perforation of the Descemets membrane occurred in 32% (9/28) of the DALK eyes, and 18% (5/28) of the patients required conversion to PK. Endothelial cell loss was not significantly different between DALK and PK when cases with perforation of Descemets membrane were included in the (intention-to-treat) analysis (12 months: 19.1 ± 21.6 vs. 27.7 ± 11.1 P = 0.112). Rejection episodes were reported in 1 patient in the DALK group (epithelial rejection) and 3 patients in the PK group (all endothelial rejections). No graft failure occurred. CONCLUSIONS One year after DALK performed without perforation of Descemets membrane, EC loss is significantly lower, whereas the BSCVA is comparable to that in the PK group. In addition, no endothelial rejection occurred in the DALK group. However, Descemets membrane perforation remains a major complication in DALK and warrants improvements to standardize the big-bubble technique.

Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial.

Background. To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease. Methods. A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease were randomized to FLEK or PK. Clinical outcomes (astigmatism and visual acuity) and incidence of postoperative complications were compared between the two groups. Results. At 12 months, the percentage of eyes with a refractive astigmatism less than or equal to 3 diopters was higher in the FLEK group in comparison with the PK group (86.2% vs. 51.3%, P=0.004). The mean postoperative best corrected visual acuity was 20/70±2 lines in the FLEK group and 20/44±2 lines in the PK group (P<0.001), but the gain in the best corrected visual acuity between the two groups was not significantly different. The endothelial cell loss in the FLEK and PK group was 65±12% and 23±15% (P<0.001). The most common postoperative complication in the FLEK group was graft dislocation (27.8%). Wound healing related problems occurred in six eyes (15%) in the PK group and in none of the FLEK eyes. Conclusions. FLEK effectively reduces postoperative astigmatism and results in an absence of wound healing related problems in patients with endothelial disease. However, visual acuity is lower as compared with conventional PK, and the high level of endothelial cell loss warrants a modification of the insertion technique of the endothelial graft.

Preliminary results of femtosecond laser-assisted descemet stripping endothelial keratoplasty

OBJECTIVE To evaluate the preliminary visual results of femtosecond laser-assisted Descemet stripping endothelial keratoplasty (FS-DSEK). METHODS We prospectively analyzed results of 20 consecutive patients with Fuchs endothelial dystrophy or aphakic/pseudophakic bullous keratopathy who underwent FS-DSEK. Best spectacle-corrected visual acuity (BSCVA), refraction, corneal topography, and endothelial cell density were measured preoperatively and 3 and 6 months after FS-DSEK. Corneal thickness was measured using an optical coherence tomography technique. RESULTS The average BSCVA of 11 eyes with normal visual potential significantly improved from 20/110 +/- 4 lines to 20/57 +/- 1 line at 6 months (P < .007). At 6 months, the mean (SD) hyperopic shift was 2.24 (2.3) diopters (D). Preoperative and 6 months postoperative refractive astigmatism were -0.75 (0.9) D and -1.58 (1.1) D (P = .01), but the topographic astigmatism did not change postoperatively (P = .95). Mean (SD) endothelial cell density at 6 months was 1368 (425) cells/mm(2). There was a persistent deswelling of the graft up to 3 months postoperatively. Complications included graft dislocations requiring repositioning (20%), pupillary block glaucoma (5%), epithelial ingrowth (5%), and primary graft failure (5%). CONCLUSIONS Femtosecond laser-assisted Descemet stripping endothelial keratoplasty was effective in treating endothelial failure with minimal induced refractive astigmatism, limited improvement of BSCVA, and induction of a hyperopic shift. Endothelial cell count and dislocation rate were significant, which may be related to the surgical technique.

Effect of oral acyclovir after penetrating keratoplasty for herpetic keratitis: a placebo-controlled multicenter trial.

OBJECTIVE To determine the prophylactic effect of oral acyclovir on the recurrence rate of herpetic eye disease after penetrating keratoplasty. DESIGN A randomized, double-masked, placebo-controlled multicenter trial. PARTICIPANTS Sixty-eight consecutive patients (68 eyes) with corneal opacities due to herpetic eye disease who underwent penetrating keratoplasty. INTERVENTION Oral acyclovir 400 mg twice daily or placebo tablets for 6 months. MAIN OUTCOME MEASURES The recurrence rate of herpetic eye disease-related events and rejection episodes, proven by viral cell culture or polymerase chain reaction. RESULTS During the 2-year follow-up period, there were 3 culture-proven herpetic eye disease recurrences in the acyclovir group and 9 in the placebo group. Lifetime survival analysis of the probability of remaining free from recurrence revealed a significantly reduced risk of recurrent herpetic disease in the acyclovir-treated group. CONCLUSION This study suggests that oral acyclovir effectively prevents herpes-related recurrences after penetrating keratoplasty in herpetic eye disease.

CAUSES OF HIGH ASTIGMATISM AFTER PENETRATING KERATOPLASTY

We retrospectively evaluated the factors which might have caused excessive corneal astigmatism after penetrating keratoplasty (PKP) in 29 eyes, in which surgical correction of astigmatism was indicated. In 18 eyes high astigmatism (5 diopters or more) existed before suture removal probably due to graft elevation (3×), wound dehiscence (3×), wound configuration abnormalities such as ovality/overcut (8×), and a thin recipient cornea (2×). The cause was unknown in 2 eyes. In 19 eyes the astigmatism considerably increased after all sutures were removed; astigmatism increased an average of 8.8 diopters (range, 5 to 16.5 D). Ten of these 19 patients showed graft elevation, despite the fact that the sutures were only removed after an average 22.9 months. In 3 other patients the astigmatism gradually increased over the years, long after suture removal; two of these showed graft elevation. The study demonstrates the possible instability of keratoplasty wounds, the change in astigmatism after suture removal, and the late apparently spontaneous changes in astigmatism after PKP in some eyes.

Unusual deposits in the superficial corneal stroma following combined use of topical corticosteroid and beta-blocking medication.

Clinical observation of eight patients with superficial stromal precipitation of calcium phosphate is presented. In all cases the predisposing factors for the formation of these depositions were: epithelial defects and the combined use of topical dexamethason phosphate or prednisolon phosphate with topical beta-blocking agents. In two patients the medication that gave rise to these precipitates was used without preservatives, suggesting that the medication itself and not the preservatives contribute to the deposits. Discontinuance of simultaneous administration of the steroids and beta-blocking agents prevented further formation of precipitates. The authors suggest an interaction between simultaneously given steroid and betablocking agents, giving rise to calcium phosphate precipitates when an epithelial defect is present which allows easy access to the superficial corneal stroma.

Organ Culture Preservation for Corneal Tissue

INTRODUCTION The technical and quality aspects of organ culture as a storage method for human donor corneas are described. MATERIALS AND METHODS Data electronically stored since 1989 of > 41,000 corneas, processed in the Cornea Bank Amsterdam, are analysed. The technical information of eye banks collected in the Directory of the European Eye Bank Association (EEBA) is used as comparison. European Union (EU) directive for tissue banking and EEBA technical guidelines are references for the quality aspects. RESULTS Organ culture allows the storage of donor corneas up to 4-5weeks. The storage phase is followed by a generally much shorter phase of 1-7 days, to reverse the corneal swelling occurring in the first phase and to transport the tissue to the clinic. Selection of the corneas based on inspection of the endothelium after storage as well as microbiological testing of the storage solution after a quarantine period are mandatory for this technique. General agreement exists about the outline of the method, but technical variations are applied to suit local circumstances and preferences of corneal surgeons. Agreement exists about a minimum endothelial cell count as selection criterion in case the donor endothelium is meant to be grafted. The use and cutoff points of other selection parameters for the cornea, e.g. the endothelial cell mosaic, are varying. According to EU regulations, a quality management system should be installed. This way each bank is able to issue a standardized product, while the production process is monitored with quality registrations. With the clinical outcome of the graft, the quality of the selection and storage procedures is verified. With the notification of adverse reactions such as primary graft failure and endophthalmitis, minimum risks will be assessed. CONCLUSION The organ-cultured cornea is a well-documented product concerning microbiological safety and quality of the tissue. However, variations in performance and materials and no definite cut-off points for selection do not make an organ-cultured cornea a generally standardized product. The corneal surgeons have to ascertain themselves of the safety and quality of the followed procedure. It is up to an organization such as the EEBA to formulate tissue-specific additions to the EU regulations such as training opportunities, technical guidelines and criteria based on science.

Economic Evaluation of Deep Anterior Lamellar Keratoplasty Versus Penetrating Keratoplasty in The Netherlands

PURPOSE To evaluate the cost effectiveness of deep anterior lamellar keratoplasty (DALK) versus penetrating keratoplasty (PK) in The Netherlands. DESIGN Cost-effectiveness analysis alongside a randomized, multicenter clinical trial. METHODS Fifty-three patients with corneal stromal pathologic features not affecting the endothelium were included with 28 patients in the DALK group and 25 in the PK group. Quality of life was measured before surgery and 3, 6, and 12 months after surgery. The main outcome measures were incremental cost-effectiveness ratios per clinically improved patient on the 25-item National Eye Institute Visual Functioning Questionnaire and per patient with endothelial cell loss of maximally 20% within the first year. RESULTS Mean total bootstrapped costs per patient were €7607 (US

Five-year follow-up on the effect of oral acyclovir after penetrating keratoplasty for herpetic keratitis.

10,498) in the DALK group and €6552 (US

A retrospective study on the effectiveness of oral acyclovir to prevent herpes simplex recurrence in corneal grafts

9042) in the PK group. The incremental cost-effectiveness ratios were €9977 (US