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
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

Opthalmology
F00, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7RH
United Kingdom

Phone +44 (0)207 1887 188
Email davidobrart@aol.com

Study information

Study designRandomized, bilateral-controlled, prospective clinical investigation
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedKeratoconus
InterventionRandomized, 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 typeSupplement
Primary outcome measureTo determine whether Riboflavin/ UVA corneal cross-linkage can prevent the progression of keratoconus. The non-treated eye will act as a control.
Secondary outcome measuresTo 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 date05/06/2006
Completion date04/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants36
Key inclusion criteria36 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 criteria1. 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 enrolment05/06/2006
Date of final enrolment04/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Opthalmology
London
SE1 7RH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2011 Yes No