Quality of Vision and Quality of Life With LASIK

Completed

• Conditions: Quality of Lifte; Myopia; Astigmatism

• Registration Number: NCT02161263
• Lead Sponsor: Edward E. Manche

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-03-01
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Vision and Quality of Life Questionnaires after LASIK Surgery	12 months	Patients will complete questionnaires preoperatively and postoperatively at month twelve.

Trial Locations

Locations (1)

Stanford Eye Laser Center; 🇺🇸 Palo Alto, California, United States