Risk factors influencing survival of acellular porcine corneal stroma in infectious keratitis: a prospective clinical study

Saiqun Li, Meng Li, Li Gu, Lulu Peng, Yuqing Deng, Jing Zhong, Bowen Wang, Qian Wang, Yichen Xiao, Jin Yuan, Saiqun Li, Meng Li, Li Gu, Lulu Peng, Yuqing Deng, Jing Zhong, Bowen Wang, Qian Wang, Yichen Xiao, Jin Yuan

Abstract

Background: A 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.

Methods: In 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.

Results: The 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).

Conclusions: APCS 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.

Keywords: Acellular porcine corneal stroma; Infectious keratitis; Therapeutic lamellar keratoplasty.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Architecture of acellular porcine corneal stroma (APCS). Hematoxylin and eosin (H&E) staining of APCS (a) and human cornea (b). Total magnification = 100×. Scanning electron micrography (SEM) images of APCS (c) and human cornea (d). Total magnification = 1000×
Fig. 2
Fig. 2
Pre- and postoperative outcomes of 3 patients who underwent therapeutic lamellar keratoplasty using acellular porcine corneal stroma (APCS) for medically unresponsive infectious keratitis. Images were obtained in eyes before surgery (a, e), and at 1 day (b, f), 3 months (c, g) and 12 months (d, h) postoperatively
Fig. 3
Fig. 3
Visual outcomes in eyes undergoing acellular porcine corneal stroma (APCS) transplantation. The majority of patients had improved best-corrected visual acuity (BCVA) at 12 months after surgery. The points on the diagonal line show that the BCVA was the same preoperatively and 12 months postoperatively. Counting fingers, hand motion and light perception are shown as logarithm of the minimum angle of resolution (logMAR) values of 0.004, 0.002 and 0.001, respectively
Fig. 4
Fig. 4
Slit-lamp microscopy images of eyes with graft failure. a–c A patient was diagnosed with fungal keratitis who experienced recurrent infection within 1 week after the operation. A repeated PKP was performed. d–f A patient with mild eyelid deformity and lagophthalmos, which resulted in neovessel ingrowth and led to late graft dissolution. g–i A patient with a diagnosis of herpes simplex keratitis who had persistent epithelial defects after the operation that ultimately progressed to corneal ulceration. j–l The graft was transparent in the initial postoperative period, but neovessels later grew into the center of the graft
Fig. 5
Fig. 5
Kaplan–Meier survival curve depicting the graft failure episodes in eyes submitted to acellular porcine corneal stroma (APCS) implantation. a Total graft survival; b graft survival in eyes with various types of infectious keratitis; c graft survival in eyes with a graft size larger or smaller than a diameter of 8 mm. HSK, herpes simplex keratitis

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