Quality of Vision and Quality of Life With LASIK

Sponsor
Edward E. Manche (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02161263
Collaborator
(none)
50
1
142
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Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Mar 1, 2014
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Quality of Vision after LASIK surgery

Questionnaire

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

Outcome Measures

Primary Outcome Measures

  1. Quality of Vision and Quality of Life Questionnaires after LASIK Surgery [12 months]

    Patients will complete questionnaires preoperatively and postoperatively at month twelve.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Eye Laser Center Palo Alto California United States 94303

Sponsors and Collaborators

  • Edward E. Manche

Investigators

  • Principal Investigator: Edward E Manche, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edward E. Manche, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier:
NCT02161263
Other Study ID Numbers:
  • 30301
First Posted:
Jun 11, 2014
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Edward E. Manche, Professor of Ophthalmology, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021