Clincosm LogoSign in Get a demo

Clinical and Structural Outcome of Conventional Versus Accelerated Corneal Collagen Cross-linking (CXL).

Sponsor
Oslo University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02883478
Collaborator
(none)
40
Enrollment
2
Arms
48
Duration (Months)

Study Details

Study Description

Brief Summary

Compare different corneal parameters and visual outcome of corneal collagen cross-linking (CXL) with conventional versus accelerated ultraviolet-A irradiation using riboflavin with hydroxypropyl methylcellulose.

Condition or Disease Intervention/Treatment Phase
  • Device: UV-X 1000 (3 mW/cm²)
  • Procedure: UV-X 2000 (9 mW/cm²)
  • Drug: riboflavin with hydroxypropyl methylcellulose
 Phase 1/Phase 2

Detailed Description

40 patients with signs of progressive keratoconus are randomized to either corneal collagen cross-linking (CXL) with conventional ultraviolet-A (UVA) irradiation at 3 milliwatt/cm² (mW/ cm²) or accelerated ultraviolet-A (UVA) irradiation at 9 mW/ cm². In both groups riboflavin with hydroxypropyl methylcellulose was used. The objectives of this study are to evaluate and compare different corneal parameters (maximum corneal curvature, depth of collagen cross-linking, endothelial cell density) and clinical outcomes of uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA)) after CXL with conventional and accelerated UVA irradiation.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study of Clinical and Structural Outcome of Corneal Collagen Crosslinking (CXL) With Conventional Versus Accelerated Ultraviolet-A Irradiation Using Riboflavin With Hydroxypropyl Methylcellulose (HPMC).
Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Aug 1, 2016
Anticipated Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment group A

Corneal collagen cross-linking using riboflavin with hydroxypropyl methylcellulose solution and ultraviolet-A (UVA) irradiation at 3 milliwatt/cm² (mW/cm²) for 30 minutes. Device: UV-X 1000 irradiator (3 mW/cm²) Drug: riboflavin with hydroxypropyl methylcellulose

Device: UV-X 1000 (3 mW/cm²)
Ultraviolet-A (UVA) irradiation for 30 minutes at 3 milliwatt/cm² (mW/cm²).
Other Names:
  • conventional ultraviolet-A(UVA) irradiation

    • Drug: riboflavin with hydroxypropyl methylcellulose
    Drops of riboflavin with hydroxypropyl methylcellulose will be applied in the eye for 20 minutes before ultraviolet-A(UVA) irradiation and every 2 minutes during UVA irradiation
    Other Names:
  • riboflavin with HPMC

    		•
    Active Comparator: Treatment group B

    Corneal collagen cross-linking using riboflavin with hydroxypropyl methylcellulose solution and ultraviolet-A (UVA) irradiation at 9 mW/cm² for 10 minutes. Device: UV-X 2000 irradiator (9 mW/cm²) Drug: riboflavin with hydroxypropyl methylcellulose

    Procedure: UV-X 2000 (9 mW/cm²)
    Ultraviolet-A (UVA) irradiation for 10 minutes at 9 mW/cm².
    Other Names:
  • accelerated ultraviolet-A(UVA) irradiation

    • Drug: riboflavin with hydroxypropyl methylcellulose
    Drops of riboflavin with hydroxypropyl methylcellulose will be applied in the eye for 20 minutes before ultraviolet-A(UVA) irradiation and every 2 minutes during UVA irradiation
    Other Names:
  • riboflavin with HPMC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compare change in maximum corneal curvature, visual acuity, endothelial cell density and depth of cross-linking in CXL with conventional versus accelerated UVA irradiation. [2 years]

      Compare change in maximum corneal curvature (Kmax; diopter), uncorrected visual acuity (UCVA, logMAR), best spectacle corrected visual acuity (BSCVA, logMAR) from baseline and depth in micrometer(µm) of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy in corneal collagen cross-linking with conventional at 3 milliwatt/cm² (mW/cm²) versus accelerated (9 mW/cm²) ultraviolet-A irradiation using riboflavin with hydroxypropyl methylcellulose.

    Secondary Outcome Measures

    1. Compare depth of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy with change in endothelial cell density in CXL with conventional versus accelerated ultraviolet-A irradiation. [2 years]

      Compare depth (µm) of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy with change in endothelial cell density (ECD; cells/mm²) from baseline in CXL with conventional (3 mW/cm²) versus accelerated (9 mW/cm²) ultraviolet-A irradiation using riboflavin with hydroxypropyl methylcellulose..

    2. Compare depth of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy with change in maximal corneal curvature (Kmax) and visual acuity in CXL with conventional versus accelerated UVA irradiation. [2 years]

      Compare depth (µm) of corneal collagen crosslinking on anterior segment optical coherence tomography and confocal microscopy with change in maximal corneal curvature (Kmax; diopter), uncorrected visual acuity (UCVA, logMAR) and best spectacle corrected visual acuity (BSCVA, logMAR) from baseline in CXL with conventional (3 mW/cm²) versus accelerated (9 mW/cm²) ultraviolet-A irradiation using riboflavin with hydroxypropyl methylcellulose.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with increase of minimum of 1,0 diopter in maximum keratometry.

    • Patients with increase in corneal astigmatism of minimum 1,0 diopter.

    • Patients with in spherical equivalent of min 0,5 diopter.

    • Patients living in Eastern Norway.

    Exclusion Criteria:

    • Minimum pachymetric corneal thickness (Pentacam)<360 µm.

    • Central corneal scar.

    • Chemical burn, serious corneal infections and ocular surface diseases.

    • Pregnancy.

    • Lactation.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anne Marie Hagem, MD, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT02883478
    Other Study ID Numbers:
    • 2010/626 C S-08344c
    First Posted:
    Aug 30, 2016
    Last Update Posted:
    Aug 30, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Keratoconus
    Riboflavin

    Study Results

    No Results Posted as of Aug 30, 2016