An Evaluation of LASIK, SMILE and PRK Surgery in Physicians

Astigmatism Clinical Trial

Official title:

An Evaluation of Quality of Vision and Quality of Life With LASIK, SMILE and PRK Surgery in Physicians

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02576483
• Other study ID #: 34287
• Status: Recruiting
• Start date: July 2015
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Linda Schwartz
• Phone: 650 498-7020
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Astigmatism
• Farsightedness
• Hyperopia
• Myopia
• Nearsightedness

Intervention

Behavioral:
• Questionnaire (QoV questionnaire)
Quality of vision and quality of life questionnaire

Locations

Country	Name	City	State
United States	Byers Eye Institute at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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