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Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.
Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo simultaneous SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using Contoura with Phorcides and SMILE surgery. Surgical treatment will be randomized so there is a 50% chance to receive SMILE on the right eye and LASIK on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. Visual outcomes and patient self-reported symptoms will be assessed at week 2, month 1, month 3, and month 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LASIK using Contoura with Phorcides | Active Comparator | LASIK using Contoura with Phorcides in one eye. |
|
| SMILE | Active Comparator | small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WaveLight EX500 Excimer Laser System | Device | LASIK Refractive Surgery Using Contura with Phorcides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op | Post-operative uncorrected visual acuity of 20/16 or better measure with ETDRS chart; unit = percentage eyes with Uncorrected Visual Acuity | 6-month Post-Op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in high contrast visual acuity at 6-month Post-Op | Change in the mean uncorrected visual acuity (unit = logMAR) measure with ETDRS chart from baseline (pre-op) at 6 months post-op. | Change from baseline (pre-op) to 6-month Post-Op |
| Change in refractive error at 6-month Post-Op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in low contrast visual acuity at 6-month Post-Op | Change in the mean low contrast visual acuity (unit = logMAR) measure with ETDRS 5% chart from baseline (pre-op) at 6 months post-op. | Change from baseline (pre-op) to 6-month Post-Op |
| Change in higher order aberrations at 6-month Post-Op |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charisma B Evangelista, MD | 59th Medical Wing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Warfighter Refractive Surgery Center at WHASC | San Antonio | Texas | 78236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36539217 | Background | Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2025 | Aug 26, 2025 | 2 |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Prospective randomized contralateral study.
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| VisuMax Surgical Laser | Device | SMILE Refractive Surgery |
|
Change in the mean refractive error measure with phoropter (unit = diopters) from baseline (pre-op) at 6 months post-op. |
| Change from baseline (pre-op) to 6-month Post-Op |
Change in the mean higher order aberrations (unit = root mean square) measure with iDesign 2.0 Refractive Studio from baseline (pre-op) at 6 months post-op. |
| Changes from baseline (pre-op) to 6-month Post-Op |
| Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op | The PROWL-SS is a validated tool to assess self-reported symptoms and satisfaction after refractive surgery. Possible Satisfaction Score ranges from 1 (completely satisfied) to 6 (completely dissatisfied). Lower value indicates higher satisfaction. Possible Symptoms Score ranges from 1 (extremely bothersome) to 5 (not at all bothersome). Lower value indicates worse symptoms. | Changes from baseline (pre-op) to 6-month Post-Op |
| Change in mean score Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire at 6-month Post-Op | The SPEED is a validated tool to assess self-reported dry eye symptoms. Possible dry eye symptoms score ranges from 0 (never) to 3 (Constant). Higher value indicates worse dry eye symptoms. | Changes from baseline (pre-op) to 6-month Post-Op |