Use of chilled riboflavin and keratolac-soaked contact lenses in managing eye discomfort after crosslinking treatment

Effectiveness of chilled riboflavin and keratolac-soaked bandage contact lenses in reducing eye discomfort following corneal crosslinking for keratoconus

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000204347

Enrollment

300

Registered

2026-02-19

Start date

2026-03-01

Completion date

2028-09-01

Last updated

2026-03-02

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

Conditions

None listed

Brief summary

This randomised controlled trial will compare the effectiveness of the following approaches in reducing eye discomfort after crosslinking for keratoconus: Arm 1 - topical ocular application of 4°C 0.1% riboflavin in saline during crosslinking, plus placement of unsoaked bandage lens on eye at conclusion of crosslinking Arm 2 - topical ocular application of ambient temperature 0.1% riboflavin in saline during crosslinking, plus placement of ketorolac tromethamine-soaked bandage contact lens on eye at conclusion of crosslinking Comparator/control arm - topical ocular application of ambient temperature 0.1% riboflavin in saline during crosslinking, plus placement of unsoaked bandage lens on eye at conclusion of crosslinking

Interventions

Arm 1 - topical ocular application of 4°C 0.1% riboflavin in saline at start of crosslinking, plus placement of unsoaked bandage lens on eye at conclusion of crosslinking. Bandage lens will be applied by study clinician and removed by study clinician 3 days after crosslinking Arm 2 - topical ocular application of ambient temperature 0.1% riboflavin in saline at start of crosslinking, plus placement of ketorolac tromethamine-soaked bandage contact lens on eye at conclusion of crosslinking. Bandage lens will be applied by study clinician and removed by study clinician 3 days after crosslinking As bandage lens will be removed by study clinician 3 days after crosslinking, strategies to assess/monitor adherence to intervention are not needed

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

- Meet standard clinical criteria for crosslinking - Capacity to give informed consent

Exclusion criteria

- Contraindication for crosslinking - Contraindication for ketorolac - Prior eye procedure - Serious eye disease other than keratoconus - Any condition/medication use which could affect eye pain perception - Inability to give informed consent - Inability to report pain levels, use oral/topical analgesics as needed or return for follow-up visits

Outcome results