| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN08013636 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0013180304 |
| Public title | A randomised prospective study to investigate the efficacy of corneal collagen cross linkage with riboflavin (vitamin B2) and ultraviolet A light (UVA) (370nm) to halt the progression of keratoconus |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Keratoconus |
| Study hypothesis | The aim is to determine whether the progression of keratoconus can be halted by strengthening the cornea by cross-linkage of its collagen using ultraviolet A (UVA) light and riboflavin (vitamin B) as a photosensitizer. |
| Design/methodology | Randomized, bilateral-controlled, prospective clinical investigation |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 36 patients with moderate bilateral keratoconus recruited from the corneal and contact lens clinics at Guy's and St. Thomas' NHS Foundation Trust. Inclusion criteria:
1. Age 18 to 70
2. Must fully understand the investigative nature of the study
3. Moderate to advanced bilateral keratoconus
4. No known allergies to pre- and post-operative medications
Willingness to attend for follow-up examinations |
| Participants - exclusion criteria | 1. Age below 18
2. Other pre-existing ophthalmic pathology
3. Previous ophthalmic surgery
4. Unilateral keratoconus
5. Severe keratoconus in which the cornea is so distorted that accurate refractive and corneal measurements cannot be obtained (in these eyes data confirming stability or progression is not possible) |
| Patient information material |
|
| Anticipated start date | 05/06/2006 |
| Anticipated end date | 04/12/2007 |
| Status of trial | Completed |
| Target number of participants | 36 |
| Interventions | Randomized, bilateral-controlled, prospective clinical investigation (one eye acts as control while opposite acts as study) whereby riboflavin eye drops are applied and ultraviolet A light is shone into corneal surface. Study group undergoes full ophthalmic examination of both eyes, a full refraction test, corneal topography, keratometry, corneal pachymetry and applanation tonometry, at 1 day, week, month then month 3, 6, 12 & 18. |
| Primary outcome measure(s) | To determine whether Riboflavin/ UVA corneal cross-linkage can prevent the progression of keratoconus. The non-treated eye will act as a control. |
| Secondary outcome measure(s) | To determine whether Riboflavin/UVA corneal cross-linkage can reverse some of the bowing of the cornea caused by keratoconus. To determine whether non-treated eyes have progression of keratoconus compared to those eyes which underwent cross-linkage treatment. |
| Sources of funding | Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr David O'Brart |
| Contact details | Opthalmology
F00, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
United Kingdom
SE17RH |
| Contact telephone | +44 0207 1887 188 |
| Contact fax | +44 |
| Contact email | david.o'brart@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN08013636 |
| Date last extracted from ISRCTN register | 17/04/2008 |
