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. - UVA/B2
- Conditions
- Keratoconus affects the young, presenting in adolescence with impaired vision. This distortion of vision is due to the forward bowing of the weakened cornea. This is thought to be due to a congenital anomaly as there can be a family history.
- Registration Number
- EUCTR2006-000348-26-GB
- Lead Sponsor
- Guy's & St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
Age 18 to 70
Must fully understand the investigative nature of the study
Moderate to advanced bilateral keratoconus
No known allergies to pre- and post-operative medications
Willingness to attend for follow-up examinations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Age below 18
Other pre-existing ophthalmic pathology
Previous ophthalmic surgeryUnilateral keratoconus
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method