PURPOSE: To determine whether deep anterior lamellar keratoplasty (DALK) using acellular glycerol-cryopreserved corneal tissue (GCCT) could prevent allograft rejection in high-risk corneas. DESIGN: Prospective, randomized, comparative study. SETTINGS: The Eye Hospital, Wenzhou Medical College, Zhejiang, China. STUDY POPULATION: All patients with herpes simplex virus keratitis, bacterial keratitis, fungal keratitis, or ocular burn, who were eligible as per study design, were invited to participate. OBSERVATION PROCEDURES: According to randomized block design, all patients received either GCCT or fresh corneal tissue (FCT) during DALK. Best-corrected visual acuity (BCVA), slit-lamp microscopy, and in vivo confocal microscopy examinations at 1 week and 1, 3, 6, 12, and 24 months after surgery were analyzed. Kaplan-Meier survival analysis was used to evaluate graft survival rate. MAIN OUTCOME MEASURES: Therapeutic success, 2-year rejection-free graft survival rate and 2-year graft survival rate, in vivo confocal microscopy results, BCVA, and endothelial cell density. RESULTS:Postoperative BCVA of 20/40 or better at the last follow-up visit was achieved in 57.6% (19/33) of eyes in the GCCT group and in 54.8% (17/31) of the FCT group. No graft rejection occurred in the GCCT group, while in the FCT group 10 episodes of stromal rejection developed in 7 eyes. Overall, the rejection-free graft survival rate at 2 years was significantly higher in the GCCT group as compared with the FCT group (100.0%, 78.8% respectively, P = .006). CONCLUSIONS: Deep anterior lamellar keratoplasty using acellular glycerol-preserved cornea could prevent allograft rejection and promote graft survival rate in high-risk corneas.
RCT Entities:
PURPOSE: To determine whether deep anterior lamellar keratoplasty (DALK) using acellular glycerol-cryopreserved corneal tissue (GCCT) could prevent allograft rejection in high-risk corneas. DESIGN: Prospective, randomized, comparative study. SETTINGS: The Eye Hospital, Wenzhou Medical College, Zhejiang, China. STUDY POPULATION: All patients with herpes simplex virus keratitis, bacterial keratitis, fungal keratitis, or ocular burn, who were eligible as per study design, were invited to participate. OBSERVATION PROCEDURES: According to randomized block design, all patients received either GCCT or fresh corneal tissue (FCT) during DALK. Best-corrected visual acuity (BCVA), slit-lamp microscopy, and in vivo confocal microscopy examinations at 1 week and 1, 3, 6, 12, and 24 months after surgery were analyzed. Kaplan-Meier survival analysis was used to evaluate graft survival rate. MAIN OUTCOME MEASURES: Therapeutic success, 2-year rejection-free graft survival rate and 2-year graft survival rate, in vivo confocal microscopy results, BCVA, and endothelial cell density. RESULTS: Postoperative BCVA of 20/40 or better at the last follow-up visit was achieved in 57.6% (19/33) of eyes in the GCCT group and in 54.8% (17/31) of the FCT group. No graft rejection occurred in the GCCT group, while in the FCT group 10 episodes of stromal rejection developed in 7 eyes. Overall, the rejection-free graft survival rate at 2 years was significantly higher in the GCCT group as compared with the FCT group (100.0%, 78.8% respectively, P = .006). CONCLUSIONS:Deep anterior lamellar keratoplasty using acellular glycerol-preserved cornea could prevent allograft rejection and promote graft survival rate in high-risk corneas.
Authors: Vladimir Lamm; Hidetaka Hara; Alex Mammen; Deepinder Dhaliwal; David K C Cooper Journal: Xenotransplantation Date: 2014-02-21 Impact factor: 3.907
Authors: Xiao-Jing Pan; Tao Jiang; Hai Zhu; Peng-Peng Liu; Zhan-Yu Zhou; Alexander J Mao Journal: Int J Ophthalmol Date: 2016-01-18 Impact factor: 1.779