NCT02883478

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

May 30, 2016

Last Update Submit

August 24, 2016

Conditions

KeratoconusCorneal Ectasia

Outcome Measures

Primary Outcomes (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.

    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.

    2 years

Secondary Outcomes (2)

  • 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 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

Study Arms (2)

Treatment group A

ACTIVE COMPARATOR

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)Drug: riboflavin with hydroxypropyl methylcellulose

Treatment group B

ACTIVE COMPARATOR

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)Drug: riboflavin with hydroxypropyl methylcellulose

Interventions

UV-X 1000 (3 mW/cm²)DEVICE

Ultraviolet-A (UVA) irradiation for 30 minutes at 3 milliwatt/cm² (mW/cm²).

Also known as: conventional ultraviolet-A(UVA) irradiation
Treatment group A
UV-X 2000 (9 mW/cm²)PROCEDURE

Ultraviolet-A (UVA) irradiation for 10 minutes at 9 mW/cm².

Also known as: accelerated ultraviolet-A(UVA) irradiation
Treatment group B
riboflavin with hydroxypropyl methylcelluloseDRUG

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

Also known as: riboflavin with HPMC
Treatment group ATreatment group B

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Minimum pachymetric corneal thickness (Pentacam)\<360 µm.
  • Central corneal scar.
  • Chemical burn, serious corneal infections and ocular surface diseases.
  • Pregnancy.
  • Lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratoconus

Interventions

RadiotherapyRadiationRiboflavinHypromellose Derivatives

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical PhenomenaFlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological FactorsCelluloseGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 30, 2016

First Posted

August 30, 2016

Study Start

August 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share