Condition category
Eye Diseases
Date applied
14/02/2008
Date assigned
27/03/2008
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Chad Rostron

ORCID ID

Contact details

Duke Elder Eye Unit (Moorfields Eye Department)
St George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom
+44 (0)20 8725 2325
rostron@sgul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CHAR1004

Study information

Scientific title

Pilot study of corneal collagen cross-linking with riboflavin (C3R) with pre-operative orthokeratology

Acronym

C3R

Study hypothesis

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

Moorfields and Whittington Hospitals Research Ethics Committee, 01/12/2006, ref: 06/Q0504/106

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

05/09/2007

Overall trial end date

05/09/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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)

Recruitment start date

05/09/2007

Recruitment end date

05/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Duke Elder Eye Unit (Moorfields Eye Department)
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Moorfields Eye Hospital NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.moorfields.nhs.uk/Home

Funders

Funder type

Hospital/treatment centre

Funder name

Moorfield Eye Hospital Special Trustees (UK)

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

Publication citations

Additional files

Editorial Notes