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

University of Oslo (UIO)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Keratoconus; Corneal Ectasia

Treatments: Device: UV-X 1000 (3 mW/cm²); Drug: riboflavin with hydroxypropyl methylcellulose; Procedure: UV-X 2000 (9 mW/cm²)

Study type: Interventional

Funder types: Other

Identifiers

NCT02883478

2010/626 C S-08344c

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Treatment group A

Active Comparator group

Description:

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:

Drug: riboflavin with hydroxypropyl methylcellulose

Device: UV-X 1000 (3 mW/cm²)

Treatment group B

Active Comparator group

Description:

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:

Procedure: UV-X 2000 (9 mW/cm²)

Drug: riboflavin with hydroxypropyl methylcellulose