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| Name | Class |
|---|---|
| Eyecare Center | OTHER |
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LASIK is the most commonly performed refractive surgery worldwide. It has been shown to be safe and effective procedure with predictable results over long term follow ups. With the advancement of technology, sub-Bowman keratomileusis allows thin flap of approximately 100 microns thickness thus preserving thicker stromal bed as compared to conventional LASIK. The femtosecond laser corneal flap has th advantage of producing a flap of uniform thickness, adjustable flap diameter, relatively few complications. The disadvantages of this procedure is the high cost of surgery, development of bubbles in the corneal layer and anterior chamber which may affect pupil trackingduring the procedure. Despite the emergence of femtosecond laser-assisted flap creation, mechanical microkeratomes remain the preferred choice in the majority of developing countries. Recent studies have shown that SBK corneal flap has the same advantages as femtosecond laser flap regarding flap uniformity, regularity, and accuracy with less suction time and cost, but with its specific complications as well.
It is a prospective comparative non randomized interventional clinical study
Primary outcomes of this study include:
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moria SBK microkeratome | Other | Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia |
|
| 200-kHz Femtosecond laser system | Other | Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBK microkeratome versus femtosecond laser in flap creation | Device | prospective comparative non randomized interventional clinical study |
|
| Measure | Description | Time Frame |
|---|---|---|
| flap thickness accuracy | comparison between the accuracy of the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia, 1 month after surgery using anterior segment OCT | 1 month post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity measurment | measuring UCVA and BCVA | 1day, 1 week, 1 month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yehia Salah El Din, MD | Professor of Ophthalmology, Kasr Al Aini | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Care Center | Maadi | Cairo Governorate | Egypt |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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