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The patients will complete a voluntary questionnaire that evaluates their subjective impression of the refractive surgery, their recovery and their outcomes. Specifically, the patient will report the use of refractive correction, usefulness of the surgery at work, dry eye complaints, and subjective appraisal of their vision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin-C; 3 week FML steroid taper | Experimental | Mitomycin-C 0.01% will be administered intraoperatively during PRK for 15 seconds. The patient will take a 3 week fluorometholone 1% topical steroid taper. |
|
| Mitomycin-C; 1 week FML steroid taper | Experimental | Mitomycin-C 0.01% will be administered intraoperatively during PRK for 15 seconds. The patient will take a 1 week of fluorometholone 1% topical steroid. |
|
| No mitomycin-C; 8 week FML steroid taper | Active Comparator | No mitomycin-C will be administered during the procedure. Instead a sham application of salt solution will be given for 15 seconds. The patient will take 8 weeks of topical fluorometholone 1% topical steroid drop taper. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin-C | Drug | 0.01% applied to cornea with a sponge during PRK |
|
| Measure | Description | Time Frame |
|---|---|---|
| Refractive Error | Objective refractive error with Wavescan Aberrometry | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive Error | Manifest refraction by patient subjective report | 12 months |
| Corneal haze | Subjective grading by slit lamp examiner |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John B Cason, M.D. | United States Naval Medical Center, San Diego | Principal Investigator |
| Donna Murdoch, Ph.D. | Navy Warfighter Refractive Surgery San Diego | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy Warfighter Refractive Surgery Center | San Diego | California | 92134 | United States |
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| ID | Term |
|---|---|
| D003318 | Corneal Opacity |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| D005469 | Fluorometholone |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| Fluorometholone 1% topical ocular steroid | Drug | topical steroid drops applied to the cornea after PRK |
|
|
| 12 months |
| Corneal haze | Subclinical objective measurement of corneal haze by Pentacam densitometry | 12 months |
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |