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Institution changed surgical method to small-incision lenticule extraction. Study never started.
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Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia.
Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia.
The study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wavefront-guided LASIK | Active Comparator | One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK. |
|
| Conventional LASIK | Active Comparator | One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser in situ keratomileusis (LASIK) | Procedure | Wavefront guided treatment in one eye, conventional in the other. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular higher order aberrations | Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Ivarsen, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Aarhus University Hospital | Aarhus | DK-8000 | Denmark |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| 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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|
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |