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Clinical Trials/NCT02161263
NCT02161263
Completed
Not Applicable

Patient Quality of Vision and Quality of Life With LASIK Surgery

Edward E. Manche1 site in 1 country49 target enrollmentMarch 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Edward E. Manche
Enrollment
49
Locations
1
Primary Endpoint
Quality of Vision and Quality of Life Questionnaires after LASIK Surgery
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2014
End Date
February 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Edward E. Manche
Responsible Party
Sponsor Investigator
Principal Investigator

Edward E. Manche

Professor of Ophthalmology

Stanford University

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Quality of Vision and Quality of Life Questionnaires after LASIK Surgery

Time Frame: 12 months

Patients will complete questionnaires preoperatively and postoperatively at month twelve.

Study Sites (1)

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