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Corneal Collagen Cross-linking with Riboflavin (C3R) with orthokeratology

Pilot study of corneal collagen cross-linking with riboflavin (C3R) with pre-operative orthokeratology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29378493
Enrollment
20
Registered
2008-03-27
Start date
2007-09-05
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal ectasia Eye Diseases Corneal deformities

Interventions

Corneal collagen cross-linking with riboflavin and UV light, plus or minus orthokeratology. Pre-operatively: 10 patients will be fitted with a specially-made contact lens, which they will need to w

Sponsors

Moorfields Eye Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Corneal ectasia (keratoconus, pellucid marginal degeneration or post-excimer laser corneal ectasia) in patients intolerant or with limited tolerance of contact lenses. The only other options would be INTACS or corneal grafting.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years or greater than 40 years 2. Maximal K greater than 60D 3. Minimal Oculus Pentacam pachymetry less than 400 u, to avoid the risk of endothelial damage 4. Evidence of other corneal disease in the eye to be treated (e.g., herpes simplex keratitis) 5. Women who are pregnant or nursing at the time of the initial treatment 6. Presence of significant central corneal opacity 7. Patients unwilling to not wear their rigid contact lenses in the eye to be treated for at least one month before baseline examination, and for the first six months post-operatively (this will be necessary in order to obtain accurate refraction and keratometry readings)

Design outcomes

Primary

MeasureTime frame
The difference in the pre- and post-operative: 1. Unaided visual acuity 2. Best corrected visual acuity 3. Refraction

Secondary

MeasureTime frame
Corneal topographical profile, measured pre-operatively and at one and six months post-operatively.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026