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Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.
Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wavefront guided LASIK/PRK | Active Comparator | Wavefront-guided LASIK/PRK |
|
| Wavefront optimized LASIK/PRK | Active Comparator | Wavefornt optimized LASIK/PRK |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LASIK and PRK | Procedure | Wavefront-guided versus wavefront-optimized LASIK or PRK. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in best spectacle corrected visual acuity. | One year | |
| Changes in 25 and 5% low contrast visual acuity. | One year | |
| Improvement in uncorrected visual acuity | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in higher order aberrations. | One year | |
| Topographic changes. | One year | |
| Quality of vision changes. |
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Inclusion Criteria:
Exclusion Criteria:Autoimmune diseases.
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| Name | Affiliation | Role |
|---|---|---|
| Edward E. Manche | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32159820 | Background | Smith RG, Manche EE. One-Year Outcomes From a Prospective, Randomized, Eye-to-Eye Comparison of Wavefront-Guided and Wavefront-Optimized PRK in Myopia. J Refract Surg. 2020 Mar 1;36(3):160-168. doi: 10.3928/1081597X-20200129-01. | |
| 30201128 | Background | Lee MD, Toy BC, Manche EE. Astigmatic outcomes in myopic wavefront-guided laser in situ keratomileusis versus wavefront-guided photorefractive keratectomy using vector analysis. J Cataract Refract Surg. 2018 Nov;44(11):1350-1354. doi: 10.1016/j.jcrs.2018.07.022. Epub 2018 Sep 7. |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| D018903 | Photorefractive Keratectomy |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| One year |
| 25321951 | Background | He L, Manche EE. Contralateral eye-to-eye comparison of wavefront-guided and wavefront-optimized photorefractive keratectomy: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):51-9. doi: 10.1001/jamaophthalmol.2014.3876. |
| 27070229 | Background | Kung JS, Manche EE. Quality of Vision After Wavefront-Guided or Wavefront-Optimized LASIK: A Prospective Randomized Contralateral Eye Study. J Refract Surg. 2016 Apr;32(4):230-6. doi: 10.3928/1081597X-20151230-01. |
| 24560995 | Background | He L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol. 2014 Jun;157(6):1170-1178.e1. doi: 10.1016/j.ajo.2014.02.037. Epub 2014 Feb 19. |
| 25419115 | Background | Sales CS, Manche EE. One-year eye-to-eye comparison of wavefront-guided versus wavefront-optimized laser in situ keratomileusis in hyperopes. Clin Ophthalmol. 2014 Nov 12;8:2229-38. doi: 10.2147/OPTH.S70145. eCollection 2014. |
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |