Clinical trial NCT03913338: Laser In-situ Keratomileusis With Crosslinking Compared to Conventional LASIK in Patients With High Myopia
Official title: A Controlled Evaluation of the Safety and Efficacy of Laser In-situ Keratomileusis With Crosslinking (XtraLASIK) Compared to Conventional LASIK (convLASIK) in Patients With High Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Myopic Astigmatism
Crosslinking
Corneal Ectasia
Myopic Regression
Lead sponsor: University Clinic Frankfurt
Sponsor class: OTHER
Collaborators: name: Glaukos Corporation
First posted: 2019-04-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, intra-patient controlled, clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: uncorrected distant visual acuity
timeFrame: 12 months postoperative
measure: best spectacle corrected distant visual acuity
timeFrame: 12 months postoperative
measure: spherical equivalent
timeFrame: 12 months postoperative
Secondary outcomes:
measure: endothelial cell count
timeFrame: 12 months postoperative
measure: Corneal thickness
timeFrame: 12 months postoperative
measure: Subjective visual quality
timeFrame: 12 months postoperative
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of ophthalmology University clinic Frankfurt
state: Hessen
Study officials:
affiliation: Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main
name: Thomas Kohnen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: