Trials / Unknown
UnknownNCT02883478
Clinical and Structural Outcome of Conventional Versus Accelerated Corneal Collagen Cross-linking (CXL).
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).
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | UV-X 1000 (3 mW/cm²) | Ultraviolet-A (UVA) irradiation for 30 minutes at 3 milliwatt/cm² (mW/cm²). |
| PROCEDURE | UV-X 2000 (9 mW/cm²) | Ultraviolet-A (UVA) irradiation for 10 minutes at 9 mW/cm². |
| DRUG | 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 |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2016-08-30
- Last updated
- 2016-08-30
Source: ClinicalTrials.gov record NCT02883478. Inclusion in this directory is not an endorsement.