A randomized, bilateral, controlled, prospective study to investigate the efficacy of corneal shape customised versus standard whole central cornea riboflavin/ultraviolet A corneal collagen cross-linking

A randomized, bilateral, controlled, prospective study to investigate the efficacy of tomography-orientated versus standard axial riboflavin/ultraviolet A corneal collagen cross-linking

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52187987

Enrollment

Registered

2018-02-03

Start date

2018-03-01

Completion date

Unknown

Last updated

2022-08-15

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

Conditions

Keratoconus, corneal ectasia Eye Diseases Keratoconus

Interventions

Patients will undergo a routine eye examination to determine the precise degree of keratoconus and then after full consent as to the risks and benefits of the procedure undergo cross-linking treatment

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 to 18 months 2. Grade I-III keratoconus (3mm keratometry less than 55 diopters, cone apex power less than 70 diopters, central pachymetry greater than 400um) 3. Age over 18

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in: 1. Refractive error (diopters) 2. Topographic simulated keratometry (diopters) (corneal curvature) 3. Maximum keratometry (Kmax) 4. Posterior corneal curvature 5. Pentacam-derived keratoconus indices 6. Belin-Ambrosio enhanced ectasia scores 7. Corneal pachymetry (micrometers) 8. Visual acuity (logMar) Measured at baseline 6, 12 and 18 months	—

Secondary

Measure	Time frame
Stability in: 1. Refractive error (diopters) 2. Topographic simulated keratometry (diopters) (corneal curvature) 3. Maximum keratometry (Kmax) 4. Posterior corneal curvature 5. Pentacam-derived keratoconus indices 6. Belin-Ambrosio enhanced ectasia scores 7. Corneal pachymetry (micrometers) 8. Visual acuity (logMar) 9. Endothelial cell counts 10. Sight-threatening complications Measured at baseline 6, 12 and 18 months	—

Measure

Time frame

Stability in: 1. Refractive error (diopters) 2. Topographic simulated keratometry (diopters) (corneal curvature) 3. Maximum keratometry (Kmax) 4. Posterior corneal curvature 5. Pentacam-derived keratoconus indices 6. Belin-Ambrosio enhanced ectasia scores 7. Corneal pachymetry (micrometers) 8. Visual acuity (logMar) 9. Endothelial cell counts 10. Sight-threatening complications Measured at baseline 6, 12 and 18 months

—

Countries

England, United Kingdom

Outcome results

None listed

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