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| Name | Class |
|---|---|
| Glaukos Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Other | LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap. |
|
| Control group | Other | LASIK only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LasikXtra | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| uncorrected distant visual acuity | uncorrected distant visual acuity (logarithmic minimum angle of resolution) | 12 months postoperative |
| best spectacle corrected distant visual acuity | best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution) | 12 months postoperative |
| spherical equivalent | spherical equivalent (diopter) | 12 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| endothelial cell count | endothelial cell count (number of cells/ mm2) | 12 months postoperative |
| Corneal thickness | Corneal thickness (micro millimeter) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Kohnen, Prof. Dr. | Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ophthalmology University clinic Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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Prospective, randomized, intra-patient controlled, clinical trial
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|
| LASIK | Procedure | 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. |
|
| 12 months postoperative |
| Subjective visual quality | Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum) | 12 months postoperative |
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |