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.
Conditions
Interventions
Product Name: Riboflavin Eye Drops
Pharmaceutical Form: Eye drops*
INN or Proposed INN: Riboflavin
Other descriptive name: Riboflavin Eye Drops
Concentration unit: % percent
Concentration type: equal
Sponsors
Guy's & St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of riboflavin (vitamin B2) 0.1% eye drops and ultraviolet A light (UVA) at 370nm to cause photochemical collagen cross-linkage to strengthen the cornea and prevent the progression of keratoconus.;Secondary Objective: To determine whether Riboflavin/UVA corneal cross-linkage can reverse some of the bowing of the cornea caused by keratoconus;Primary end point(s): To determine whether Riboflavin/UVA corneal cross-linkage can prevent the progression of keratoconus. Efficacy parameters will be determined by comparing the pre- and postoperative refractive power (diopters), astigmatic power (analyzed by vector analysis), unaided and best spectacle corrected visual acuities (Logmar),corneal power in the 3mm, 5mm and 7mm central zones (assessed by corneal topography) and the inferior versus superior power differences (diopters) within these zones using paired t-tests. Data will be analyzed using paired and unpaired t-tests with quantatative continuous data such as visual, refractive and corneal power changes and with chi squared analysis with non-continuous data. | — |
Countries
United Kingdom
Outcome results
None listed