Penetrating keratoplasty (PK) vs deep anterior lamellar keratoplasty (DALK) for keratoconus treatment: a multicentre, controlled, randomized clinical trial

Abstract

Background: Nowadays, keratoconus (KC) is considered the first indication of cornea transplantation among young people. Historically, penetrating keratoplasty (PK), which involves replacement of total corneal thickness, has been the gold standard for the surgical treatment of KC, but the emergence of lamellar techniques, which involve the selective replacement of affected corneal layers, has created a subject of controversy when choosing the best surgical option for patients with KC. The Deep anterior lamellar keratoplasty (DALK) is the lamellar surgical technique especially indicated for KC, which does not replace the endothelial layer of the patient's cornea to eliminate the possibility of endothelial graft rejection. The lower probability of endothelial rejection of DALK regarding PK has been what has encouraged us to carry out this study. Objective: The aim of this study is to evaluate the non-inferiority of DALK regarding PK by comparing the following outcome indicators: visual acuity, astigmatism and intraocular pressure. Design: A multicenter, controlled, randomized clinical trial with 238 patients in each branch of treatment. A non- probabilistic sampling will be performed in order to include the patients in our study. The study is expected to be completed in three years. Setting: This study will take place in the following hospitals: Hospital Vall d ́Hebron (Barcelona), Hospital Clinic (Barcelona), Hospital Universitario La Paz (Madrid), Hospital General Universitario Gregorio Marañón and Hospital Universitari i Politècnic La Fe (Valencia). The reference hospital will be Hospital Clinic. Participants: patients with KC tributaries for surgery