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

Oslo University Hospital40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Keratoconus Corneal Ectasia

Interventions

UV-X 1000 (3 mW/cm²)DEVICE

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

UV-X 2000 (9 mW/cm²)PROCEDURE

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

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..

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.

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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