A Phase 3 interventional study of Corneal Collagen Crosslinking in Keratoconus, sponsored by Sahlgrenska University Hospital. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Sahlgrenska University Hospital · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether corneal collagen crosslinking is effective in the treatment of progressive keratoconus.
Keratoconus is a noninflammatory, asymmetrical, progressive corneal ectasia caused by biomechanical instability of the corneal stroma. Treatment modalities are primarily glasses or contact lenses. It has been estimated that one out of five patients will progress to such an extent that a corneal transplant is necessary to regain useful vision.
Corneal collagen crosslinking (CXL) is a treatment modality that intends to halt progression of keratoconus. This study investigates the efficacy av CXL in stabilizing the cornea in keratoconus by means of a randomized controlled clinical trial.
Participants are eligible for inclusion if progressive keratoconus is confirmed and the inclusion criteria are met. Follow-up after inclusion is at 1 week (treatment group), 1, 3, 6 and 12 months. Pre- and post-inclusion examinations include measurement of uncorrected distance visual acuity (UCDVA), best spectacle corrected distance visual acuity (BSCDVA), Scheimpflug-topography and slitlamp examination.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Significant progression is defined as change (increase) of Kmax by at least
1D from baseline at 6 months and/or change (increase) of Sim-K-ast by at least 1D from baseline at 6 months. Kmax is defined as the steepest radius of curvature (either the maximum simulated K-reading or the maximum K-reading in the 3-mm zone or the 5-mm zone) of the anterior corneal surface that progressed the most during 6 months observation
Exclusion Criteria:
Relative exclusion criteria:
The keratokonic eye which progresses most is included and randomized. Significant progression is defined in the eligibility criteria section. If randomized to the treatment arm the cornea is treated with collagen crosslinking as described below.
Device: Corneal Collagen Crosslinking
The keratokonic eye which progresses most is included and randomized to either the treatment group (CXL) or the control group.
Keratoconic corneas that show significant progression as specified in the inclusion criteria section will receive one single treatment with CXL if randomized to the treatment arm. A treatment protocol based on 30 minutes dropping with riboflavin/dextran solution and 10 minutes UV-illumination treatment will be used.
Also known as: Cross-Linking Procedure UV-X 2000, UV-X 2000 Illumination system, Innocross-R 0.1% dextran 20% solution, Innocross-R hypotonic riboflavin 0.1%
Kmax
Kmax is defined as the steepest radius of curvature of the anterior corneal surface. It is measured by Scheimpflug-topography (Pentacam, Oculus Inc.). An increase of less than 1 diopter (D) from baseline at 12 months is defined as non-progression.
Time frame: 12 months
Sim-K-astigmatism
Sim-K-astigmatism (Sim-K-ast) is defined as the absolute amount of anterior corneal astigmatism related to the Sim-Ks as measured by Scheimpflug-topography (Pentacam, Oculus Inc.). An increase of less than 1 D from baseline at 12 months is defined as non progression.
Time frame: 12 months
MRSE
Manifest Refractive Spherical Equivalent. The spherical equivalent is calculated by algebraic addition of the spherical power and half the cylindrical power of an eye. An eye with a specific spherical equivalent power has the closest overall effect to a given toric lens. A decrease of less than 0.5 D from baseline at 12 months is defined as non-progression.
Time frame: 12 months
UCDVA
UCDVA is defined as the uncorrected distance visual acuity measured with an Early Treatment of Diabetic Retinopathy Study (ETDRS)-chart and expressed in numbers of letters. A decrease of less than 5 letters (one line) from baseline at 12 months is defined as stable BCDVA.
Time frame: 12 months
BSCDVA
BSCDVA is defined as the the best spectacle corrected distance visual acuity measured with an ETDRS-chart and expressed in numbers of letters. A decrease of less than 5 letters (one line) from baseline at 12 months is defined as stable BCDVA.
Time frame: 12 months
Plan to share: No
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Sahlgrenska University Hospital