Overview

This trial is active, not recruiting.

Conditions keratoconus, corneal ectasia
Treatments uv-x 1000 (3 mw/cm²), uv-x 2000 (9 mw/cm²), riboflavin with hydroxypropyl methylcellulose
Phase phase 1/phase 2
Sponsor Oslo University Hospital
Start date August 2012
End date August 2016
Trial size 40 participants
Trial identifier NCT02883478, 2010/626 C S-08344c

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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
uv-x 1000 (3 mw/cm²) conventional ultraviolet-A(UVA) irradiation
Ultraviolet-A (UVA) irradiation for 30 minutes at 3 milliwatt/cm² (mW/cm²).
riboflavin with hydroxypropyl methylcellulose riboflavin with HPMC
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
(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
uv-x 2000 (9 mw/cm²) accelerated ultraviolet-A(UVA) irradiation
Ultraviolet-A (UVA) irradiation for 10 minutes at 9 mW/cm².
riboflavin with hydroxypropyl methylcellulose riboflavin with HPMC
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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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 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

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

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.

Additional Information

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).
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.