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A randomised controlled trial on cross-linking protocols for the treatment of progressive keratoconus using isoosmolar and hypoosmolar riboflavin with the addition of sterile water in thin corneae

Gustafsson, Ingemar LU orcid ; Olafsdotttir, Thorbjörg LU ; Neumann, Olof LU ; Bizios, Dimitrios LU orcid ; Ivarsen, Anders and Hjortdal, Jesper (2025) In Acta Ophthalmologica
Abstract

Purpose: To present the outcomes of a randomised clinical trial for the treatment of progressive keratoconus using different kinds of riboflavin and the addition of sterile water in thin corneae. Methods: A randomised study using epithelium-off corneal cross-linking (CXL) with continuous UVA irradiance 9 mW/cm2 for 10 min (total fluence 5.4 J/cm2) and two kinds of riboflavin solutions: (i) isoosmolar dextran-based riboflavin (n = 27) and (ii) hypoosmolar dextran-free riboflavin (n = 27) for the treatment of progressive keratoconus. Visual acuity (corrected and uncorrected), tomographic parameters and endothelial cell count were obtained at baseline and after 1 year. Corneae thinner than 400 μm were also included. A... (More)

Purpose: To present the outcomes of a randomised clinical trial for the treatment of progressive keratoconus using different kinds of riboflavin and the addition of sterile water in thin corneae. Methods: A randomised study using epithelium-off corneal cross-linking (CXL) with continuous UVA irradiance 9 mW/cm2 for 10 min (total fluence 5.4 J/cm2) and two kinds of riboflavin solutions: (i) isoosmolar dextran-based riboflavin (n = 27) and (ii) hypoosmolar dextran-free riboflavin (n = 27) for the treatment of progressive keratoconus. Visual acuity (corrected and uncorrected), tomographic parameters and endothelial cell count were obtained at baseline and after 1 year. Corneae thinner than 400 μm were also included. A safety limit of 400 μm was used, and sterile water was added if the corneae fell short of this limit during the treatment. Primary outcome: Change in Kmax. Results: There were no statistically significant differences in any of the parameters between the isoosmolar and hypoosmolar groups. In the isoosmolar group, 74% of the patients required the addition of sterile water, while only 15% required it in the hypoosmolar group. The measurements of densitometry in the 0–2 mm zone improved less in the group that received sterile water; otherwise, there were no statistically significant differences in any of the parameters between the groups that did and did not receive the addition of sterile water. Conclusions: The results of this study demonstrate the efficacy and safety in using hypoosmolar riboflavin when performing CXL for progressive keratoconus. The results also demonstrate the efficacy and safety of using sterile water in corneae thinner than 400 μm.

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author
; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
in press
subject
keywords
cornea, crosslinking, keratoconus, randomised clinical trial, tomography
in
Acta Ophthalmologica
publisher
Wiley-Blackwell
external identifiers
  • scopus:105010168663
  • pmid:40630024
ISSN
1755-375X
DOI
10.1111/aos.17551
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2025 The Author(s). Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.
id
ee420750-4ff6-4c31-89df-ecbe0aa008ef
date added to LUP
2026-01-07 15:45:04
date last changed
2026-01-08 08:27:07
@article{ee420750-4ff6-4c31-89df-ecbe0aa008ef,
  abstract     = {{<p>Purpose: To present the outcomes of a randomised clinical trial for the treatment of progressive keratoconus using different kinds of riboflavin and the addition of sterile water in thin corneae. Methods: A randomised study using epithelium-off corneal cross-linking (CXL) with continuous UVA irradiance 9 mW/cm<sup>2</sup> for 10 min (total fluence 5.4 J/cm<sup>2</sup>) and two kinds of riboflavin solutions: (i) isoosmolar dextran-based riboflavin (n = 27) and (ii) hypoosmolar dextran-free riboflavin (n = 27) for the treatment of progressive keratoconus. Visual acuity (corrected and uncorrected), tomographic parameters and endothelial cell count were obtained at baseline and after 1 year. Corneae thinner than 400 μm were also included. A safety limit of 400 μm was used, and sterile water was added if the corneae fell short of this limit during the treatment. Primary outcome: Change in Kmax. Results: There were no statistically significant differences in any of the parameters between the isoosmolar and hypoosmolar groups. In the isoosmolar group, 74% of the patients required the addition of sterile water, while only 15% required it in the hypoosmolar group. The measurements of densitometry in the 0–2 mm zone improved less in the group that received sterile water; otherwise, there were no statistically significant differences in any of the parameters between the groups that did and did not receive the addition of sterile water. Conclusions: The results of this study demonstrate the efficacy and safety in using hypoosmolar riboflavin when performing CXL for progressive keratoconus. The results also demonstrate the efficacy and safety of using sterile water in corneae thinner than 400 μm.</p>}},
  author       = {{Gustafsson, Ingemar and Olafsdotttir, Thorbjörg and Neumann, Olof and Bizios, Dimitrios and Ivarsen, Anders and Hjortdal, Jesper}},
  issn         = {{1755-375X}},
  keywords     = {{cornea; crosslinking; keratoconus; randomised clinical trial; tomography}},
  language     = {{eng}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Acta Ophthalmologica}},
  title        = {{A randomised controlled trial on cross-linking protocols for the treatment of progressive keratoconus using isoosmolar and hypoosmolar riboflavin with the addition of sterile water in thin corneae}},
  url          = {{http://dx.doi.org/10.1111/aos.17551}},
  doi          = {{10.1111/aos.17551}},
  year         = {{2025}},
}