Astigmatism Clinical Trial
Official title:
An Evaluation of Quality of Vision and Quality of Life With LASIK, SMILE and PRK Surgery in Physicians
NCT number | NCT02576483 |
Other study ID # | 34287 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | January 2025 |
Verified date | April 2024 |
Source | Stanford University |
Contact | Linda Schwartz |
Phone | 650 498-7020 |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The principle investigator is evaluating self-reported quality of vision and quality of life in physicians undergoing LASIK, SMILE and PRK surgery.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 62 Years |
Eligibility | Inclusion criteria. - 21 years or older. - A physician or medical student. - Have the ability to give informed consent. - Speak and read English fluently. - Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery. - May benefit from increased spectacle independence. - Have been determined to be a good candidate for the LASIK, SMILE or PRK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations. - Have a treatment target of bilateral emmetropia. - Express willingness and potential ability to return for all follow-up examinations through the 12-month follow-up exam under the care of the treating investigator. - Are not enrolled in any other research study. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Byers Eye Institute at Stanford | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported quality of vision and quality of life questionnaire | Twleve months | ||
Secondary | Predictability (Percentage of eyes within 0.25, +/- 0.50 and +/- 1.00 diopters of the intended correction | Preoperatively, one, three, six and twelve months | ||
Secondary | Changes in CDVA (Corrected distance visual acuity) | Preoperatively, one, three, six and twelve months | ||
Secondary | Changes in low contrast acuity (5% and 25% contrast acuity) | Preoperatively, one, three, six and twelve months | ||
Secondary | Self-reported quality of life and quality of vision (QoV questionnaire) | Preoperatively, one, three and six months |
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