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Quality of Vision and Quality of Life With LASIK

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ClinicalTrials.gov Identifier: NCT02161263
Recruitment Status : Active, not recruiting
First Posted : June 11, 2014
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University

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

Condition or disease Intervention/treatment
Myopia Astigmatism Quality of Lifte Other: Patient Quality of Life andVision 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Quality of Vision and Quality of Life With LASIK Surgery
Actual Study Start Date : March 1, 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Quality of Vision after LASIK surgery
Questionnaire
Other: Patient Quality of Life andVision after LASIK Surgery
Patient questionnaire




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults over the age of 21 with healthy eyes and nearsightedness, farsightedness and/or astigmatism
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161263


Locations
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United States, California
Stanford Eye Laser Center
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Edward E. Manche
Investigators
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Principal Investigator: Edward E Manche, MD Stanford University

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Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT02161263     History of Changes
Other Study ID Numbers: 30301
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Keywords provided by Edward E. Manche, Stanford University:
LASIK
Satisfaction
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases