Contact information
Type
Scientific
Primary contact
Mr David O'Brart
ORCID ID
Contact details
Opthalmology
F00
South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7RH
United Kingdom
+44 (0)207 1887 188
davidobrart@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013180304
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomized, bilateral-controlled, prospective clinical investigation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
riboflavin (vitamin B2)
Primary outcome measures
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 trial start date
05/06/2006
Overall trial end date
04/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
36
Participant 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)
Recruitment start date
05/06/2006
Recruitment end date
04/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Opthalmology
London
SE1 7RH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21349938
Publication citations
-
Results
O'Brart DP, Chan E, Samaras K, Patel P, Shah SP, A randomised, prospective study to investigate the efficacy of riboflavin/ultraviolet A (370 nm) corneal collagen cross-linkage to halt the progression of keratoconus., Br J Ophthalmol, 2011, 95, 11, 1519-1524, doi: 10.1136/bjo.2010.196493.