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| ID | Type | Description | Link |
|---|---|---|---|
| FWH20230084H | Other Identifier | 59 HRPP |
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Participants will undergo LASIK using Contoura with Phorcides calculation on one eye and LASIK using iDesign calculation 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 LASIK using Contoura with Phorcides calculation on one eye and LASIK using iDesign calculation 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 calculation vs. LASIK using iDesign calculation. Surgical treatment will be randomized so there is a 50% chance to receive LASIK using Contoura with Phorcides vs LASIK using iDesign calculation on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. This will be a prospective randomized double blind contralateral study. The patient and the staff doing the post-op evaluations will be blinded to which eye received which treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LASIK using Contoura with Phorcides | Active Comparator | Alcon VISX Star S4 IR LASIK ablation calculation using Contoura with Phorcides |
|
| LASIK using iDesign | Active Comparator | Alcon VISX Star S4 IR LASIK ablation calculation using iDesign Refractive Studio 2.0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contoura Topolyzer with Phorcides | Device | LASIK calculated ablation using Contoura Topolyzer 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 |
|---|---|---|
| Samantha B Rodgers, 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 |
|---|---|---|---|
| 41665909 | Derived | Dudenhoefer NE, Rodgers SB, Evangelista CB, Legault GL, Chen SS, Kohler PD, Capo-Aponte JE. Comparison of clinical and patient-reported outcomes of contralateral topography-guided vs wavefront-guided LASIK. J Cataract Refract Surg. 2026 Jul 1;52(7):641-649. doi: 10.1097/j.jcrs.0000000000001905. |
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| 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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This is a prospective randomized double blind contralateral study. The patient and the staff doing the post-op evaluations will be blinded to which eye received which treatment.
| iDesign | Device | LASIK calculated ablation using iDesign Refractive Studio 2.0 |
|
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. |
| Change 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. | Change 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. | Change from baseline (pre-op) to 6-month Post-Op |