Trans-epithelial corneal cross-linking to halt the progression of keratoconus
Not Applicable
Completed
- Conditions
- Keratoconus, post-refractive surgery ectasiaEye DiseasesKeratoconus
- Registration Number
- ISRCTN04451470
- Lead Sponsor
- Guy's & St Thomas' Foundation NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 46
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Stability of refractive error (diopters)<br> 2. Topographic simulated keratometry (diopters) (corneal curvature)<br> 3. Corneal pachymetry (micrometers)<br> 4. Visual acuity (logMar) at 12 months compared to pre-operative values<br><br> These parameters will be measured pre-operatively and at 3, 6 and 12 months.<br>
- Secondary Outcome Measures
Name Time Method <br> 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<br> 2. Complications if present will be documented at 1 week and 1, 3, 6 and 12 months after surgery<br>