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
ISRCTN | ISRCTN08013636 |
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DOI | https://doi.org/10.1186/ISRCTN08013636 |
Secondary identifying numbers | N0013180304 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 12/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr David O'Brart
Scientific
Scientific
Opthalmology
F00, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7RH
United Kingdom
Phone | +44 (0)207 1887 188 |
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davidobrart@aol.com |
Study information
Study design | Randomized, bilateral-controlled, prospective clinical investigation |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Keratoconus |
Intervention | 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. |
Intervention type | Supplement |
Primary outcome measure | 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 measures | 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. |
Overall study start date | 05/06/2006 |
Completion date | 04/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 36 |
Key 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 |
Key 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) |
Date of first enrolment | 05/06/2006 |
Date of final enrolment | 04/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Opthalmology
London
SE1 7RH
United Kingdom
SE1 7RH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust
No information available
Own account
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/11/2011 | Yes | No |