NCT02161263

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

8.9 years

First QC Date

June 6, 2014

Last Update Submit

March 17, 2024

Conditions

Keywords

LASIKSatisfaction

Outcome Measures

Primary Outcomes (1)

  • Quality of Vision and Quality of Life Questionnaires after LASIK Surgery

    Patients will complete questionnaires preoperatively and postoperatively at month twelve.

    12 months

Study Arms (1)

Quality of Vision after LASIK surgery

Questionnaire

Other: Patient Quality of Life andVision after LASIK Surgery

Interventions

Patient questionnaire

Quality of Vision after LASIK surgery

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults over the age of 21 with healthy eyes and nearsightedness, farsightedness and/or astigmatism

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Eye Laser Center

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

MyopiaAstigmatismPersonal Satisfaction

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesBehavior

Study Officials

  • Edward E Manche, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 11, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations