Efficacy of customized corneal crosslinking versus standard corneal crosslinking in patients with progressive keratoconus (C-CROSS study): study protocol for a randomized controlled trial

BMC Ophthalmology

Study Protocol

Bjorn Winkens¹  Abhijit Sinha Roy²  Rohit Shetty²  Robert-Jan H. J. Wijdh³  Robert P. L. Wisse⁴  Frank J. H. M. van den Biggelaar⁵  Mor M. Dickman⁵  Rudy M. M. A. Nuijts⁵  Nienke Visser⁵  Tos T. J. M. Berendschot⁶  Magali M. S. Vandevenne⁶ 

[1] Department of Methodology and Statistics, Faculty of Health, Medicine, and Life Sciences (FHML), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands;Narayana Nethralaya Eye Hospital, Bangalore, India;Ophthalmology Department, University Medical Centre Groningen, Groningen, the Netherlands;Ophthalmology Department, University Medical Centre Utrecht, Utrecht, the Netherlands;University Eye Clinic Maastricht, Maastricht University Medical Centre+, P Debyelaan 25, 6229 HX, Maastricht, the Netherlands;University Eye Clinic Maastricht, Maastricht University Medical Centre+, P Debyelaan 25, 6229 HX, Maastricht, the Netherlands;School for Mental Health and Neuroscience (MHeNS), Maastricht University, Maastricht, the Netherlands;

关键词: Keratoconus;    Crosslinking;    Customized;   

DOI  :  10.1186/s12886-023-02976-4

 received in 2023-03-06, accepted in 2023-05-12,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundKeratoconus is a degenerative disorder of the cornea leading to a protrusion and thinning with loss of visual acuity. The only treatment to halt the progression is corneal crosslinking (CXL), which uses riboflavin and UV-A light to stiffen the cornea. Recent ultra-structural examinations show that the disease is regional and does not affect the entire cornea. Treating only the affected zone with CXL could be as good as the standard CXL, that treats the entire cornea.MethodsWe set up a multicentre non-inferiority randomized controlled clinical trial comparing standard CXL (sCXL) and customized CXL (cCXL). Patients between 16 and 45 years old with progressive keratoconus were included. Progression is based on one or more of the following changes within 12 months: 1 dioptre (D) increase in keratometry (Kmax, K1, K2); or 10% decrease of corneal thickness; or 1 D increase in myopia or refractive astigmatism, requiring corneal crosslinking.DiscussionThe goal of this study is to evaluate whether the effectiveness of cCXL is non-inferior to sCXL in terms of flattening of the cornea and halting keratoconus progression. Treating only the affected zone could be beneficial for minimalizing the risk of damaging surrounding tissues and faster wound healing. Recent non-randomized studies suggest that a customized crosslinking protocol based on the tomography of the patient’s cornea may stop the progression of keratoconus and result in flattening of the cornea.Trial registrationThis study was prospectively registered at ClinicalTrials.gov on August 31st, 2020, the identifier of the study is NCT04532788.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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