EUCTR2006-000348-26-GB
Active, not recruiting
Phase 1
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
Guy's & St Thomas' NHS Foundation Trust0 sites36 target enrollmentApril 21, 2006
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Guy's & St Thomas' NHS Foundation Trust
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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