Collagen Crosslinking for Keratoconus - a Randomized Controlled Clinical Trial

NCT ID: NCT01604135

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2025-04-30

Brief Summary

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

Detailed Description

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.

Conditions

Keratoconus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Corneal Collagen Crosslinking

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.

Group Type: ACTIVE_COMPARATOR

Corneal Collagen Crosslinking

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Corneal Collagen Crosslinking

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.

Intervention Type: DEVICE

Other Intervention Names

Cross-Linking Procedure UV-X 2000; UV-X 2000 Illumination system; Innocross-R 0.1% dextran 20% solution; Innocross-R hypotonic riboflavin 0.1%

Eligibility Criteria

Inclusion Criteria

• Keratoconus diagnosis determined clinically and topographically (KISA%- index)
• 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

• Ability to stop contact lens (rigid and soft) wear at least two weeks prior to next exam
• Signed written informed consent

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wolf K Wonneberger, MD

Ophthalmologist, Cornea and External Diseases Team

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madeleine Zetterberg, MD, PhD

Role: STUDY_CHAIR

Sahlgrenska University Hospital

Margareta Claesson, MD, PhD

Role: STUDY_DIRECTOR

Sahlgrenska University Hospital

Locations

Department of Ophthalmology, Sahlgrenska University Hospital

Mölndal, Västra Götalandsregionen, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 21183110 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21700105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12719068 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24393351 (View on PubMed)

Other Identifiers

DNR-949-11

Identifier Type: -

Identifier Source: org_study_id