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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Keratoconus Corneal Ectasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

UV-X 1000 (3 mW/cm²)

Intervention Type DEVICE

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

riboflavin with hydroxypropyl methylcellulose

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

UV-X 2000 (9 mW/cm²)

Intervention Type PROCEDURE

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

riboflavin with hydroxypropyl methylcellulose

Intervention Type DRUG

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

Interventions

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UV-X 1000 (3 mW/cm²)

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

Intervention Type DEVICE

UV-X 2000 (9 mW/cm²)

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

Intervention Type PROCEDURE

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

Intervention Type DRUG

Other Intervention Names

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conventional ultraviolet-A(UVA) irradiation accelerated ultraviolet-A(UVA) irradiation riboflavin with HPMC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No