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ISRCTN
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ISRCTN08013636
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013180304
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomized, bilateral-controlled, prospective clinical investigation
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Eye Diseases: Keratoconus
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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05/06/2006
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Anticipated end date
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04/12/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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36
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Interventions
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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.
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Primary outcome measure(s)
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To determine whether Riboflavin/ UVA corneal cross-linkage can prevent the progression of keratoconus. The non-treated eye will act as a control.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
David
O'Brart
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Address
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Opthalmology
F00, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE17RH
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Country
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United Kingdom
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Tel
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+44 0207 1887 188
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Fax
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+44
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Email
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david.o'brart@kcl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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22/10/2007
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Date ISRCTN assigned
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28/09/2007
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