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

August 24, 2016 updated by: Anne Marie Hagem, Oslo University Hospital

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).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare change in maximum corneal curvature, visual acuity, endothelial cell density and depth of cross-linking in CXL with conventional versus accelerated UVA irradiation.
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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 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.
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/626 C S-08344c

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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