Quality of Vision and Quality of Life With LASIK

Myopia Clinical Trial

Official title:

Patient Quality of Vision and Quality of Life With LASIK Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161263
• Other study ID #: 30301
• Status: Completed
• Start date: March 1, 2014
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators are administering a validated questionnaire looking at patient reported quality of life and quality of vision after LASIK surgery

Description:

The purpose of the study is to evaluate the prevalence of any functional limitations and their associated factors at one, three, six, and twelve months after LASIK surgery and finally the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, six and twelve months following LASIK surgery using two questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Are aged 21 years or older.

• 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 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 ectactic eye disorders.

• Patients with autoimmune diseases.

• Patients who are pregnant or nursing.

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Quality of Lifte

Intervention

Other:
• Patient Quality of Life andVision after LASIK Surgery
Patient questionnaire

Locations

Country	Name	City	State
United States	Stanford Eye Laser Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Edward E. Manche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Vision and Quality of Life Questionnaires after LASIK Surgery	Patients will complete questionnaires preoperatively and postoperatively at month twelve.	12 months