Corneal Ectasia, Crosslinking, Myopia, Myopic Astigmatism, Myopic Regression
Conditions
Brief summary
The objectives of this study are to evaluate the safety and efficacy of a treatment regimen for high myopia and myopic astigmatism: LASIK followed by crosslinking performed with the KXL Crosslinking-System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA), as compared to LASIK alone, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE) and keratometry.
Detailed description
This is a controlled study of the safety and efficacy of the KXL System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA) for performing crosslinking in eyes undergoing LASIK for high myopia or myopic astigmatism. Each subject will have bilateral LASIK performed and one eye will be randomized to undergo LASIK followed by crosslinking. Subjects will undergo bilateral LASIK. Following randomisation one eye of each subject will be treated with VibeX Xtra (Riboflavin Ophthalmic Solution) following LASIK and will be irradiated with the KXL System at 30 mW/cm2 intensity for 90 seconds continuous UV-A light treatment for a total radiant exposure of 2.7 J /cm2. All eyes will be assessed at 1 day, 1, 3, 6, and 12 months after treatment.
Interventions
PROCEDURELasikXtra
By randomized selection, one eye was treated with the LASIK Xtra procedure that consists of fs-LASIK treatment combined with intraoperative accelerated continuous UV-riboflavin crosslinking. After laser ablation, the corneal bed under the flap was coated with riboflavin, rinsed with saline solution, and after 90 seconds the corneal flap was repositioned. The eye was irradiated at 30 mW/cm2 for 90 seconds with continuous UVA.
PROCEDURELASIK
Femtosecond-assisted preparation of a corneal flap and subsequently excimer-laser ablation of corneal stroma. Repositioning of the corneal flap and installation of a therapeutic contact lens.
Sponsors
Glaukos Corporation
University Clinic Frankfurt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Prospective, randomized, intra-patient controlled, clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* eligible for bilateral myopic fs-LASIK with -6.00 to -12.00 D (diopters) with a maximum of 5.00 D astigmatism * age \> 18 years * provided written informed consent * difference between the MRSE and cycloplegic SE less than 0.75 D * MRSE needed to be stable for the last 12 months (\<0.5 D).
Exclusion criteria
* prior corneal surgery, * forme fruste or manifest keratoconus, * history of corneal scarring, melting, ulceration * repeating inflammations of the eye * taking vitamin C 1 week prior to the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| spherical equivalent | 12 months postoperative | spherical equivalent (diopter) |
| uncorrected distant visual acuity | 12 months postoperative | uncorrected distant visual acuity (logarithmic minimum angle of resolution) |
| best spectacle corrected distant visual acuity | 12 months postoperative | best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| endothelial cell count | 12 months postoperative | endothelial cell count (number of cells/ mm2) |
| Corneal thickness | 12 months postoperative | Corneal thickness (micro millimeter) |
| Subjective visual quality | 12 months postoperative | Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum) |
Countries
Germany
Outcome results
None listed