Contact information
Type
Scientific
Primary contact
Mr Chad Rostron
ORCID ID
Contact details
Duke Elder Eye Unit (Moorfields Eye Department)
St George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom
+44 (0)20 8725 2325
rostron@sgul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CHAR1004
Study information
Scientific title
Pilot study of corneal collagen cross-linking with riboflavin (C3R) with pre-operative orthokeratology
Acronym
C3R
Study hypothesis
To assess whether orthokeratology using a specifically designed contact lens could enhance the corneal flattening effect of collagen cross-linking by ultraviolet (UV) light with riboflavin (C3R) and reduce any pre-existing astigmatism and/or myopia.
Ethics approval
Moorfields and Whittington Hospitals Research Ethics Committee, 01/12/2006, ref: 06/Q0504/106
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Corneal ectasia
Intervention
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 wear for one week prior to the surgical procedure, in an attempt to change the irregular profile of the cornea prior to undergoing the corneal collagen cross-linking (C3R) treatment. The other 10 patients will not be fitted with any kind of lens.
Surgical procedure:
The surgery will be performed on all 20 patients. Local anaesthesia with anaesthetic eye drops will be utilised. The procedure involves removal of the superficial cell layer of the cornea (epithelium) and then instilling riboflavin eye drops into the eye every three minutes for 30 minutes, until the surgeon judges that an adequate level has been obtained. At that point the ultraviolet light will be directed onto the cornea for 30 minutes to produce collagen cross-linking. Cross-links are small bridges between the fibres in the cornea which strengthen the cornea. Total time for the procedure will be about 1 hour 15 minutes to 1 hour 30 minutes.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
The difference in the pre- and post-operative:
1. Unaided visual acuity
2. Best corrected visual acuity
3. Refraction
Secondary outcome measures
Corneal topographical profile, measured pre-operatively and at one and six months post-operatively.
Overall trial start date
05/09/2007
Overall trial end date
05/09/2008
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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)
Recruitment start date
05/09/2007
Recruitment end date
05/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Duke Elder Eye Unit (Moorfields Eye Department)
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
Moorfields Eye Hospital NHS Foundation Trust (UK)
Sponsor details
c/o Professor Roger Hitchings
162 City Road
London
EC1V 2PD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Moorfield Eye Hospital Special Trustees (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary