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

Not Applicable

• Conditions: Keratoconus, corneal ectasia; Eye Diseases; Keratoconus

• Registration Number: ISRCTN52187987
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-03
• Study Completion: 2021-03-31
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 34

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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