Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
12/12/2013
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 David O'Brart

ORCID ID

Contact details

Opthalmology
F00
South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7RH
United Kingdom
+44 (0)207 1887 188
davidobrart@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013180304

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomized, bilateral-controlled, prospective clinical investigation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

riboflavin (vitamin B2)

Primary outcome measures

To determine whether Riboflavin/ UVA corneal cross-linkage can prevent the progression of keratoconus. The non-treated eye will act as a control.

Secondary outcome measures

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.

Overall trial start date

05/06/2006

Overall trial end date

04/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

36

Participant 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)

Recruitment start date

05/06/2006

Recruitment end date

04/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Opthalmology
London
SE1 7RH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21349938

Publication citations

  1. Results

    O'Brart DP, Chan E, Samaras K, Patel P, Shah SP, A randomised, prospective study to investigate the efficacy of riboflavin/ultraviolet A (370 nm) corneal collagen cross-linkage to halt the progression of keratoconus., Br J Ophthalmol, 2011, 95, 11, 1519-1524, doi: 10.1136/bjo.2010.196493.

Additional files

Editorial Notes