Laser In-situ Keratomileusis With Crosslinking Compared to Conventional LASIK in Patients With High Myopia
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|ClinicalTrials.gov Identifier: NCT03913338|
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myopia Myopic Astigmatism Crosslinking Corneal Ectasia Myopic Regression||Procedure: LasikXtra Procedure: LASIK||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized, intra-patient controlled, clinical trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Actual Study Start Date :||July 24, 2014|
|Actual Primary Completion Date :||July 3, 2018|
|Actual Study Completion Date :||July 3, 2018|
LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap.
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.
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.
- uncorrected distant visual acuity [ Time Frame: 12 months postoperative ]uncorrected distant visual acuity (logarithmic minimum angle of resolution)
- best spectacle corrected distant visual acuity [ Time Frame: 12 months postoperative ]best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)
- spherical equivalent [ Time Frame: 12 months postoperative ]spherical equivalent (diopter)
- endothelial cell count [ Time Frame: 12 months postoperative ]endothelial cell count (number of cells/ mm2)
- Corneal thickness [ Time Frame: 12 months postoperative ]Corneal thickness (micro millimeter)
- Subjective visual quality [ Time Frame: 12 months postoperative ]Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913338
|Department of ophthalmology University clinic Frankfurt|
|Frankfurt am Main, Hessen, Germany, 60590|
|Principal Investigator:||Thomas Kohnen, Prof. Dr.||Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main|