Astigmatism Clinical Trial
Official title:
A Prospective Randomized Comparison of the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK
Verified date | April 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 2025 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion criteria. - Subjects age 21 and older with healthy eyes. - Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters. Exclusion criteria. - Subjects under the age of 21. - Patients with excessively thin corneas. - Patients with topographic evidence of keratoconus. - Patients with ectatic eye disorders. - Patients with autoimmune diseases. - Patients who are pregnant or nursing. - Patients must have similar levels of nearsightedness and farsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes. - Patients must have similar levels of astigmatism in each eye. They can not have more than 1.5 diopter of difference between eyes. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Chiang B, Valerio GS, Manche EE. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries. Am J Ophthalmol. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uncorrected visual acuity | Twelve months | ||
Secondary | Quality of vision and quality of life using the QoV questionnaire | One month, three months, six months and twelve months | ||
Secondary | Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS) | One day, one month, three months, six months and twelve months | ||
Secondary | Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction) | One, three, six and twelve months | ||
Secondary | Change in best spectacle corrected visual acuity | One, three, six and twelve months | ||
Secondary | Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success | One, three six and twelve months |
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