Evaluation of the safety and efficacy of LASIK surgery using a survey on the degree of satisfaction after long term LASIK surgery

UMIN ID: UMIN000021744

Registered date:01/04/2016

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Post LASIK surgery
• Date of first enrollment: 2016/04/01
• Target sample size: 3000
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): questionnaire survey 1 year after LASIK surgery

Outcome(s)

• Primary Outcome: Answer a questionnaire below after six months and one year post-LASIK surgery. Q0-1.Institution Q0-2.Name of flap maker Q0-3.Name of excimer laser machine Q1-1.Name of patient, Patient ID or medical record number, Gender, Age Q1-2.Mail address Q1-3.Occupation Q1-4.Do you overuse your eyes at work? Q1-5.Date of surgery Q1-5.Time elapsed since surgery (months) Q1-6.Are you currently taking psychotropic medication? Q1-6-1.Sleeping medications, Tranquilizers, Antidepressants, Anti-mania medication, Anticonvulsant, Others Q1-6-2.Did you take the medication before surgery? Q1-6-3.Did you tell your physician or other medical staff that you can currently taking medications before the surgery? Q2.Satisfaction after surgery Q3.How do your expectations before the surgery compare with the results? Q4.If you are currently experiencing side effects, please list them below 0. None, 1. halo/glare/star bust, 2. dry eye, 3. over correction, 4. under correction, 5. regression, 6. night vision, 7. light sensitivity, 8. eye pain (a. back of eye, b. front of eye), 9. headache, 10. lid spasm, 11. Numbness around the eyes, 12. Glaucoma, 13. Cornea protruding, 14. Cross eyed, 15. Double vision when using one eye, 16. Asthenopia, 17. Ears ringing, 18. Insomnia, 19. Fatigue, 20. Dizziness, 21. Nausea, 22. Eye regulation dysfunction, 23. Stiff shoulders, 24. Back pain, 25. Autonomic imbalance, 26. Depression, Other comments Q5.Do you overall glad that you had surgery? Q5-1.For those responding "Yes", would you recommend LASIK to your family and friends? Q5-1-1.For those responding "Would not recommend", what is your reason?. Other comments Q5-2.For those responding "No", what is your reason? Q6.Please write any other general opinions below

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Refusing to respond to post-surgical satisfaction survey 2) When not visiting a clinical post surgery and also not submitting the survey and doctor's visit form upon request

Related Information

• Primary Sponsor: Yoshino Eye Clinic
• Source(s) of Monetary Support: LASIK Safety Network