Corneal Collagen Cross-linking with Riboflavin (C3R) with orthokeratology

ISRCTN	ISRCTN29378493
DOI	https://doi.org/10.1186/ISRCTN29378493
Secondary identifying numbers	CHAR1004

Submission date: 14/02/2008
Registration date: 27/03/2008
Last edited: 08/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Chad Rostron
Scientific

Duke Elder Eye Unit (Moorfields Eye Department)
St George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom

Phone	+44 (0)20 8725 2325
Email	rostron@sgul.ac.uk

Study information

Study design	Pilot randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Pilot study of corneal collagen cross-linking with riboflavin (C3R) with pre-operative orthokeratology
Study acronym	C3R
Study objectives	To assess whether orthokeratology using a specifically designed contact lens could enhance the corneal flattening effect of collagen cross-linking by ultraviolet (UV) light with riboflavin (C3R) and reduce any pre-existing astigmatism and/or myopia.
Ethics approval(s)	Moorfields and Whittington Hospitals Research Ethics Committee, 01/12/2006, ref: 06/Q0504/106
Health condition(s) or problem(s) studied	Corneal ectasia
Intervention	Corneal collagen cross-linking with riboflavin and UV light, plus or minus orthokeratology. Pre-operatively: 10 patients will be fitted with a specially-made contact lens, which they will need to wear for one week prior to the surgical procedure, in an attempt to change the irregular profile of the cornea prior to undergoing the corneal collagen cross-linking (C3R) treatment. The other 10 patients will not be fitted with any kind of lens. Surgical procedure: The surgery will be performed on all 20 patients. Local anaesthesia with anaesthetic eye drops will be utilised. The procedure involves removal of the superficial cell layer of the cornea (epithelium) and then instilling riboflavin eye drops into the eye every three minutes for 30 minutes, until the surgeon judges that an adequate level has been obtained. At that point the ultraviolet light will be directed onto the cornea for 30 minutes to produce collagen cross-linking. Cross-links are small bridges between the fibres in the cornea which strengthen the cornea. Total time for the procedure will be about 1 hour 15 minutes to 1 hour 30 minutes.
Intervention type	Procedure/Surgery
Primary outcome measure	The difference in the pre- and post-operative: 1. Unaided visual acuity 2. Best corrected visual acuity 3. Refraction
Secondary outcome measures	Corneal topographical profile, measured pre-operatively and at one and six months post-operatively.
Overall study start date	05/09/2007
Completion date	05/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20
Key inclusion criteria	Corneal ectasia (keratoconus, pellucid marginal degeneration or post-excimer laser corneal ectasia) in patients intolerant or with limited tolerance of contact lenses. The only other options would be INTACS or corneal grafting.
Key exclusion criteria	1. Age less than 18 years or greater than 40 years 2. Maximal K greater than 60D 3. Minimal Oculus Pentacam pachymetry less than 400 u, to avoid the risk of endothelial damage 4. Evidence of other corneal disease in the eye to be treated (e.g., herpes simplex keratitis) 5. Women who are pregnant or nursing at the time of the initial treatment 6. Presence of significant central corneal opacity 7. Patients unwilling to not wear their rigid contact lenses in the eye to be treated for at least one month before baseline examination, and for the first six months post-operatively (this will be necessary in order to obtain accurate refraction and keratometry readings)
Date of first enrolment	05/09/2007
Date of final enrolment	05/09/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Duke Elder Eye Unit (Moorfields Eye Department)

London
SW17 0QT
United Kingdom

Sponsor information

Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Professor Roger Hitchings
162 City Road
London
EC1V 2PD
England
United Kingdom

Website	http://www.moorfields.nhs.uk/Home
"ROR"	https://ror.org/03zaddr67

Funders

Funder type

Hospital/treatment centre

Moorfield Eye Hospital Special Trustees (UK)

No information available

Results and Publications

Intention to publish date
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

Editorial Notes

08/06/2017: No publications found, verifying study status with principal investigator.