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Trans-epithelial corneal cross-linking to halt the progression of keratoconus

A randomized, bilateral, controlled, prospective study to investigate the efficacy of trans-epithelial riboflavin/ultraviolet A corneal collagen cross-linking using iontophoresis to halt the progression of keratoconus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04451470
Enrollment
46
Registered
2013-11-12
Start date
2014-07-01
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

Keratoconus, post-refractive surgery ectasia Eye Diseases Keratoconus

Interventions

Patients will be recruited from the corneal clinics at Guy's and St Thomas' NHS Trust. All patients will have bilateral keratoconus or post-laser refractive surgery iatrogenic keratoconus. Patients wi

Sponsors

Guy's & St Thomas' Foundation NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Progressive keratoconus defined by an increase in refractive astigmatism, maximum keratometry, apex power of the cone by more than 1 diopter and/or a decrease in central corneal pachymetry by 10% in the preceding 2 years 2. Grade I-III keratoconus (3 mm keratometry less than 55 diopters, cone apex power less than 70 diopters, central pachymetry greater than 400 um) 3. Age over 18 years

Exclusion criteria

Exclusion criteria: 1. Advanced keratoconus (3 mm keratometry greater than 55 diopters, cone apex power greater than 70 diopters, central pachymetry less than 400 um) 2. Pregnancy 3. Corneal scarring 4. Co-existant ocular pathology other than keratoconus 5. Age less than 18 years

Design outcomes

Primary

MeasureTime frame
1. Stability of refractive error (diopters) 2. Topographic simulated keratometry (diopters) (corneal curvature) 3. Corneal pachymetry (micrometers) 4. Visual acuity (logMar) at 12 months compared to pre-operative values These parameters will be measured pre-operatively and at 3, 6 and 12 months.

Secondary

MeasureTime frame
1. Visual analogue pain scores documented for 5 days after surgery. Patients will be asked to grade the pain they are experiencing every 6 hours after surgery from 0 (no pain) to 10 (worse pain they have ever had) for 5 days following surgery 2. Complications if present will be documented at 1 week and 1, 3, 6 and 12 months after surgery

Countries

United Kingdom

Outcome results

None listed

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