An Evaluation of LASIK, SMILE and PRK Surgery in Physicians

NCT02576483 | Recruiting

• 1 other identifier: 34287
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The principle investigator is evaluating self-reported quality of vision and quality of life in physicians undergoing LASIK, SMILE and PRK surgery.

Conditions

Nearsightedness; Farsightedness; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Self-reported quality of vision and quality of life questionnaire

  Twleve months

Secondary Outcomes (4)

• Predictability (Percentage of eyes within 0.25, +/- 0.50 and +/- 1.00 diopters of the intended correction

  Preoperatively, one, three, six and twelve months

• Changes in CDVA (Corrected distance visual acuity)

  Preoperatively, one, three, six and twelve months

• Changes in low contrast acuity (5% and 25% contrast acuity)

  Preoperatively, one, three, six and twelve months

• Self-reported quality of life and quality of vision (QoV questionnaire)

  Preoperatively, one, three and six months

Interventions

Questionnaire (QoV questionnaire) BEHAVIORAL

Quality of vision and quality of life questionnaire

Eligibility Criteria

• Age: 21 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Physicians with refractive errors

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Myopia; Hyperopia; Astigmatism

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Edward E. Manche, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Schwartz

CONTACT

650 498-7020

Linda Schwartz

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 15, 2015
• Study Start: July 1, 2015
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

US (1)