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
Protocol serial number	N0013180304
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Guy's and St. Thomas' NHS Foundation Trust, Own account, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomized, bilateral-controlled, prospective clinical investigation
Secondary study design	Randomised controlled trial
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(s)	To determine whether Riboflavin/ UVA corneal cross-linkage can prevent the progression of keratoconus. The non-treated eye will act as a control.
Key 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.
Completion date	04/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Opthalmology

London
SE1 7RH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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