Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial

NCT01604135 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: DNR-949-11
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether corneal collagen crosslinking is effective in the treatment of progressive keratoconus.

Conditions

Keratoconus

Keywords

Collagen crosslinking; Keratoconus

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (4)

• Sim-K-astigmatism

  12 months

• MRSE

  12 months

• UCDVA

  12 months

• BSCDVA

  12 months

Study Arms (2)

Corneal Collagen Crosslinking

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

The keratokonic eye which progresses most is included and randomized to either the treatment group (CXL) or the control group.

Interventions

Corneal Collagen Crosslinking DEVICE

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%

Corneal Collagen Crosslinking

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Keratoconus diagnosis determined clinically and topographically (KISA%- index)
• Significant progression is defined as change (increase) of Kmax by at least
• D 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
• Ability to stop contact lens (rigid and soft) wear at least two weeks prior to next exam
• Signed written informed consent

You may not qualify if:

• Age \< 18 years
• Pregnancy
• Breast feeding
• History of corneal surgery
• History of ocular herpes simplex infection
• Minimal corneal thickness \< 300 micrometers
• Recurrent corneal erosions
• Other corneal (e g endothelial) or conjunktival diseases
• Neurodermatitis
• Severe forms av atopic disease
• Collagenoses, autoimmune or other systemic disease
• Systemic treatment with high doses of steroids
• Severe scarring och striae of the cornea
• Kmax \> 58D
• Minimal corneal thickness \< 400 micrometers (a modified CXL-treatment will be used swelling the cornea before UV-illumination treatment).

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

Department of Ophthalmology, Sahlgrenska University Hospital

Mölndal, Västra Götalandsregionen, 43180, Sweden

Location

Related Publications (4)

• Hersh PS, Greenstein SA, Fry KL. Corneal collagen crosslinking for keratoconus and corneal ectasia: One-year results. J Cataract Refract Surg. 2011 Jan;37(1):149-60. doi: 10.1016/j.jcrs.2010.07.030.

  PMID: 21183110 BACKGROUND

• Greenstein SA, Fry KL, Hersh PS. Corneal topography indices after corneal collagen crosslinking for keratoconus and corneal ectasia: one-year results. J Cataract Refract Surg. 2011 Jul;37(7):1282-90. doi: 10.1016/j.jcrs.2011.01.029.

  PMID: 21700105 BACKGROUND

• Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.

  PMID: 12719068 BACKGROUND

• Wittig-Silva C, Chan E, Islam FM, Wu T, Whiting M, Snibson GR. A randomized, controlled trial of corneal collagen cross-linking in progressive keratoconus: three-year results. Ophthalmology. 2014 Apr;121(4):812-21. doi: 10.1016/j.ophtha.2013.10.028. Epub 2014 Jan 6.

  PMID: 24393351 BACKGROUND

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Photochemotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Madeleine Zetterberg, MD, PhD

  Sahlgrenska University Hospital

  STUDY CHAIR

• Margareta Claesson, MD, PhD

  Sahlgrenska University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist, Cornea and External Diseases Team

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

SE (1)