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

Phase 1

• Conditions: Keratoconus; Corneal Ectasia
• Interventions: Device: UV-X 1000 (3 mW/cm²); Procedure: UV-X 2000 (9 mW/cm²); Drug: riboflavin with hydroxypropyl methylcellulose

• Registration Number: NCT02883478
• Lead Sponsor: Oslo University Hospital

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.

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2016-05-30
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted QC: 2016-08-24
• Last Update Submitted: 2016-08-24
• Study First Posted: 2016-08-30
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group B	riboflavin with hydroxypropyl methylcellulose	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
Treatment group A	UV-X 1000 (3 mW/cm²)	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
Treatment group A	riboflavin with hydroxypropyl methylcellulose	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
Treatment group B	UV-X 2000 (9 mW/cm²)	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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..
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.