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| Name | Class |
|---|---|
| United States Army Aeromedical Research Laboratory | FED |
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The study will compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, higher order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using iDesign and SMILE surgery.
Both SMILE and LASIK treatments are FDA-approved and are both performed routinely as standard of care surgery in the US Military. However, there is limited literature comparing quality of vision after LASIK using iDesign and SMILE refractive surgery. Our objective is to study the 6-month visual outcomes (high and 5% low contrast visual acuity, refractive error, higher order aberrations) and subject reported quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms using the PROWL and SPEED questionnaires following contralateral LASIK using iDesign and SMILE surgery. This is a prospective randomized contralateral study, including 57 subjects. 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 iDesign on the contralateral eye to correct myopia. 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 day 1, week 2, month 1, month 3, and month 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LASIK using iDesign | Active Comparator | LASIK guided by iDesign |
|
| SMILE | Experimental | SMILE Refractive Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR S4 IR Excimer Laser System | Device | LASIK with iDesign |
|
| 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 using the ETDRS chart reported as percentage of subjects; unit = percentage eyes with Uncorrected Visual Acuity | 6-month Post-Op |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in High Contrast Visual Acuity at 6-month Post-Op | Mean uncorrected high contrast visual acuity measure using the ETDRS chart measure at 6-month Post-Op; unit = LogMAR | 6-month Post-Op |
| Difference in residual Refractive Error at 6-month Post-Op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charisma B Evangelista, MD | Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center | Lackland Air Force Base | Texas | 78009 | 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. | |
| 18047004 | Background | Bharti S, Bains HS. Active cyclotorsion error correction during LASIK for myopia and myopic astigmatism with the NIDEK EC-5000 CX III laser. J Refract Surg. 2007 Nov;23(9 Suppl):S1041-5. doi: 10.3928/1081-597X-20071102-11. |
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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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| VisuMax 400 Surgical Laser | Device | small incision lenticule extraction technique |
|
Residual mean refractive error measure with phoropter at 6-month Post-Op; unit = Diopters (D) |
| 6-month Post-Op |
| Difference in Low Contrast Visual Acuity at 6-month Post-Op | Mean uncorrected low contrast visual acuity measure using the 5% ETDRS chart measure at 6-month Post-Op; unit = LogMAR | 6-month Post-Op |
| Difference in residual Higher Order Aberrations at 6-month Post-Op | Mean Higher Order Aberrations measure by iDesign 2.0 Refractive Studio at 6-month Post-Op; unit = root mean square | 6-month Post-Op |
| Difference in overall satisfaction questionnaire score at 6-month Post-Op | Mean Subject Satisfaction Score with the surgery outcome using the Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op. The score ranges from 1 (completely satisfied) to 6 (completely dissatisfied). Lower value indicates higher satisfaction. | 6-month Post-Op |
| Difference in overall Dry Eye questionnaire score at 6-month Post-Op | Mean Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire score at 6-month Post-Op. Possible dry eye symptoms score ranges from 0 (never) to 3 (Constant). Higher value indicates worse dry eye symptoms. | 6-month Post-Op |