N/A
N=94
Simultaneous TransPRK and Corneal Collagen Cross-Linking
Keratoconus
Bottom Line
View on ClinicalTrials.gov: NCT02208089 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Change in LogMAR Corrected Distance Visual Acuity (CDVA) — -0.13; -0.05 LogMAR CDVA — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transepithelial Photorefractive Keratectomy (TransPRK) (Procedure); Corneal Collagen Cross-Linking (CXL) (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bruce Allan
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in LogMAR Corrected Distance Visual Acuity (CDVA) |
-0.13; -0.05 | 0.03 sig |
| SECONDARY Clinically Significant Visual Gain |
12; 3 | 0.005 sig |
| SECONDARY Clinically Significant Visual Loss |
1; 2 | 0.13 |
| SECONDARY Change in Kmax - Maximum Local Anterior Corneal Surface Curvature on Tomography Map |
-5.5; -0.54 | — |
| SECONDARY Progression Rate |
3; 3 | — |
Summary
Young patients with keratoconus face two problems: disease progression and corneal shape irregularity leading to poor vision even in spectacles.
Corneal collagen cross-linking (CXL) is a new treatment designed to halt disease progression in keratoconus. The aim is to stiffen the cornea thereby preventing further shape deterioration.
Topography or wavefront guided transepithelial photorefractive keratectomy (transPRK) uses the excimer laser (the laser used to correct sight in 'laser eye surgery') to reduce corneal shape irregularity in early stage keratoconus, reducing dependence on contact lenses.
In transPRK, the corneal skin layer is removed in a well controlled, no touch procedure, preparing the cornea for CXL. Performing both treatments simultaneously (combining both procedures in one operation) may offer several advantages over performing CXL first then waiting for corneal shape to stabilise before performing transPRK. In particular, visual rehabilitation may be faster. This study aims to evaluate visual recovery after simultaneous CXL and transPRK in progressive early stage keratoconus. Visual recovery in these patients will be compared with results for a similar group of patients with early stage keratoconus who have already been treated with CXL alone.
Eligibility Criteria
Inclusion Criteria
- Patients with progressive stage II or III keratoconus
- CDVA < 0.00 logMAR or subjective problems with spectacle corrected visual quality (ghost images or light scatter symptoms)
Exclusion Criteria
- Active ocular surface disease
- Minimum corneal thickness <390µm (leaving 325µm residual stromal thickness after transPTK - in line with minimum thickness recommendations for the study CXL protocol)
- Vulnerable groups (patients whose capacity for giving informed consent to participate in the trial may be impaired)
Data sourced from ClinicalTrials.gov (NCT02208089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.