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The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children.
The primary objective of this trial is to provide an assessment of the "first fit" success of the Euclid orthokeratology "Phoenix" lens design versus its current "MAX" lens design when used by practitioners with moderate experience with fitting Euclid MAX orthokeratology lenses.
The hypothesis to be tested is that the "first fit" success of the redesign Euclid MAX "Phoenix" lens design is greater than that of the current MAX lens design.
The primary outcome variable is the percentage of participants successfully fit with the first lenses empirically ordered for the existing MAX lens design versus a modified MAX lens ("Phoenix") design.
This clinical investigation will be a prospective, randomized, double-masked two-arm non-crossover trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euclid orthokeratology MAX (current design) | Experimental | Euclid Orthokeratology (oprifocon A) Contact Lenses are lathe cut contact lenses with spherical posterior surfaces. The posterior curve is selected to properly fit an individual eye for orthokeratology and the anterior curve is selected to provide the necessary optical power for a temporary reduction of myopia. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. |
|
| Euclid orthokeratology MAX Phoenix (new design) | Experimental | Euclid Orthokeratology (oprifocon A) Contact Lenses are lathe cut contact lenses with spherical posterior surfaces. The posterior curve is selected to properly fit an individual eye for orthokeratology and the anterior curve is selected to provide the necessary optical power for a temporary reduction of myopia. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euclid orthokeratology MAX (current design) | Device | The current lens design |
|
| Measure | Description | Time Frame |
|---|---|---|
| First fit success rate | Percentage of children successfully fit in the first lens pair ordered (as determined by the PI) | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insight Vision Center Optometry | Costa Mesa | California | 92626 | United States | ||
| Dau Family Eye Care |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Euclid orthokeratology MAX Phoenix (new design) | Device | The new lens design |
|
| Saint Johns |
| Florida |
| 32259 |
| United States |
| Cornea and Contact Lens Institute of Minnesota | Edina | Minnesota | 55436 | United States |
| Somerset Eye Care | North Brunswick | New Jersey | 08902 | United States |
| Treehouse Eyes | Tysons Corner | Virginia | 22182 | United States |