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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN08013636
Enrollment
36
Registered
2007-09-28
Start date
2006-06-05
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus Eye Diseases Keratoconus

Interventions

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 in

Sponsors

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

Eligibility

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026