An Evaluation of LASIK, SMILE and PRK Surgery in Physicians

NCT ID: NCT02576483

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2028-01-31

Brief Summary

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

Detailed Description

The participants will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the participant from the study, then the investigator will inform the participant and make an appropriate referral. This is standard practice for laser in situ keratomileusis (LASIK) surgery, small incision lenticule extraction (SMILE) and photorefractive keratectomy (PRK) surgery.

If the participant is deemed appropriate for the study after a comprehensive examination including computerized videokeratography, then the participant can be enrolled. These exams are also standard practice for LASIK, SMILE and PRK surgery.

The Quality of Vision (QoV) Questionnaire will be administered following the pre-operative visit during which participants are enrolled and then at the three-month and twelve-month post- op visits before the participants are seen by the principle investigator. The questionnaire is the study intervention.

The participant will undergo bilateral simultaneous LASIK eye surgery, SMILE or PRK surgery. The participants will be seen pre-operatively, on the day of surgery, post op day one, one month, three months, and twelve-months as part of the study. Participants may also be seen more frequently if required from a medical standpoint. The participant will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week to four weeks after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK, SMILE and PRK surgery.

Conditions

Nearsightedness; Farsightedness; Astigmatism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Questionnaire (QoV questionnaire)

Quality of vision and quality of life questionnaire

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Edward E. Manche

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward E. Manche, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Byers Eye Institute at Stanford

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Linda Schwartz

Role: CONTACT

650 498-7020

Linda Schwartz

Role: CONTACT

Facility Contacts

Linda Schwartz, HS

Role: primary

lschwartz@stanfordmed.org

650-498-7020

Other Identifiers

34287

Identifier Type: -

Identifier Source: org_study_id