Abstract
BackgroundA worldwide lack of donor corneas demands the bioengineered corneas be developed as an alternative. The primary objective of the current study was to evaluate the efficacy of acellular porcine corneal stroma (APCS) transplantation in various types of infectious keratitis and identify risk factors that may increase APCS graft failure.MethodsIn this prospective interventional study, 39 patients with progressive infectious keratitis underwent therapeutic lamellar keratoplasty using APCS and were followed up for 12 months. Data collected for analysis included preoperative characteristics, visual acuity, graft survival and complications. Graft survival was evaluated by the Kaplan–Meier method and compared with the log-rank test.ResultsThe percentage of eyes that had a visual acuity of 20/40 or better increased from 10.3% preoperatively to 51.2% at 12 months postoperatively. Twelve patients (30.8%) experienced graft failure within the follow-up period. The primary reasons given for graft failure was noninfectious graft melting (n = 5), and the other causes included recurrence of primary infection (n = 4) and extensive graft neovascularization (n = 3). No graft rejection was observed during the follow-up period. A higher relative risk (RR) of graft failure was associated with herpetic keratitis (RR = 8.0, P = 0.046) and graft size larger than 8 mm (RR = 6.5, P < 0.001).ConclusionsAPCS transplantation is an alternative treatment option for eyes with medically unresponsive infectious keratitis. Despite the efficacy of therapeutic lamellar keratoplasty with APCS, to achieve a good prognosis, restriction of surgical indications, careful selection of patients and postoperative management must be emphasized.Trial registration Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea, NCT03105466. Registered 31 August 2016, ClinicalTrails.gov
Highlights
A worldwide lack of donor corneas demands the bioengineered corneas be developed as an alternative
As shown in hematoxylin and eosin (H&E) histological stains, these replacements consisted of highly organized collagen fibers, yet no remaining cell were detected
Descemetocele formation was observed in two patients with herpes simplex keratitis (HSK) (5.1%)
Summary
A worldwide lack of donor corneas demands the bioengineered corneas be developed as an alternative. To provide better guidance for clinical practice, we conducted this study to evaluate the efficacy of APCS keratoplasty in progressive infectious keratitis caused by a wide variety of pathogens, such as fungi, bacteria, viruses or Acanthamoeba. Another purpose of the present study was to identify some of the factors that may increase the therapeutic failure rate of APCS transplantation so that future patients with a high risk of graft failure may be excluded and avoidance measures may be taken
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