| Source of record | UK Trials |
| ISRCTN | ISRCTN29378493 |
| Date ISRCTN assigned | 27/03/2008 |
| Local reference number(s) | CHAR1004 |
| Public title | Corneal Collagen Cross-linking with Riboflavin (C3R) with orthokeratology |
| Scientific title | Pilot study of corneal collagen cross-linking with riboflavin (C3R) with pre-operative orthokeratology |
| Acronym | C3R |
| Disease/condition/study domain | Corneal ectasia |
| 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. |
| Design/methodology | Pilot randomised controlled trial |
| Research ethics review | Ethics approval received from Moorfields and Whittington Hospitals Research Ethics Committee on the 1st December 2006 (ref: 06/Q0504/106). |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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) |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 05/09/2007 |
| Anticipated end date | 05/09/2008 |
| Status of trial | Ongoing |
| Target number of participants | 20 |
| 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 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. |
| Primary outcome measure(s) | The difference in the pre- and post-operative:
1. Unaided visual acuity
2. Best corrected visual acuity
3. Refraction |
| Secondary outcome measure(s) | Corneal topographical profile, measured pre-operatively and at one and six months post-operatively. |
| Sources of funding | Moorfield Eye Hospital Special Trustees (UK) |
| Sponsor name | Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Sponsor details | c/o Professor Roger Hitchings
162 City Road
London
United Kingdom
EC1V 2PD |
| Sponsor website | http://www.moorfields.nhs.uk/Home |
| Contact name | Mr Chad Rostron |
| Contact details | Duke Elder Eye Unit (Moorfields Eye Department)
St George's Hospital
Blackshaw Road
London
United Kingdom
SW17 0QT |
| Contact telephone | +44 (0)20 8725 2325 |
| Contact fax | +44 (0)20 8725 3026 |
| Contact email | rostron@sgul.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN29378493 |
| Date last extracted from ISRCTN register | 17/04/2008 |
