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Clinical Trials/EUCTR2006-000348-26-GB
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.

Registry
who.int
Start Date
April 21, 2006
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Guy's & St Thomas' NHS Foundation Trust

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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