Unique ID issued by UMIN | UMIN000021744 |
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Receipt number | R000025080 |
Scientific Title | Evaluation of the safety and efficacy of LASIK surgery using a survey on the degree of satisfaction after long term LASIK surgery |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2022/10/07 15:30:06 |
Evaluation of the safety and efficacy of LASIK surgery using a survey on the degree of satisfaction after long term LASIK surgery
A survey on the degree of satisfaction after long term LASIK surgery
Evaluation of the safety and efficacy of LASIK surgery using a survey on the degree of satisfaction after long term LASIK surgery
A survey on the degree of satisfaction after long term LASIK surgery
Japan |
Post LASIK surgery
Ophthalmology |
Others
NO
We conducted a survey in patients who have undergone LASIK surgery regard the patients' backgrounds and satisfaction with the surgery. We evaluate the safety, efficacy, and final satisfaction of the surgery. In particular, we analyze the various reasons the satisfaction is low after postoperative trouble occurs so that we can contribute to improving the quality of refractive surgery medicine.
Safety,Efficacy
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
questionnaire survey 1 year after LASIK surgery
18 | years-old | <= |
Not applicable |
Male and Female
All patients who underwent LASIK surgery from April 1, 2014 - March 30, 2015 at "other medical organization/joint implementation organization" (excluding patients who had PRK and SMILE surgeries).
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
3000
1st name | Kenichi |
Middle name | |
Last name | Yoshino |
Yoshino Eye Clinic
Dept. of Ophthalmology
110-0005
1-20-10 Ueno, Taito-ku, Fugetsudo Bldg. 6F, Tokyo 110-0005 Japan
03-3839-5092
yoshino.eye.clinic.kenichi@nifty.ne.jp
1st name | Jyunya |
Middle name | |
Last name | Sugawara |
LASIK Safety Network
Secretary
107-0062
2-26-35, 8F, Minamiaoyama, Minato-ku, Tokyo 107-0062 Japan
03-5775-6070
inquiries@safety-lasik.net
Yoshino Eye Clinic
LASIK Safety Network
Self funding
Minami Aoyama Eye Clinic Institutional Review Board
3-3-11 Rune Aoyama Bldg. 4F, Kitaaoyama, Minato-ku, Tokyo 107-0061 Japan
03-5772-1451
info@minamiaoyama.or.jp
NO
1.吉野眼科クリニック(東京都)/Yoshino Eye Clinic(Tokyo)
2.南青山アイクリニック(東京都)/Minami Aoyama Eye Clinic (Tokyo)
3.みなとみらいアイクリニック(神奈川県)/Minatomirai Eye Clinic (Kanagawa)
4.宮田眼科病院(宮崎県)/Miyata Eye Hospital (Miyazaki
5.岡本眼科クリニック(愛媛県)/Okamoto Eye Clinic (Ehime)
6.小笠原眼科クリニック(岩手県)/Ogasawara Eye Clinic(Iwate)
7.名古屋アイクリニック(愛知県)/Nagoya Eye Clinic (Aichi)
8.坪井眼科(大阪府)/Tsuboi Eye Center (Osaka)
9.海谷眼科(静岡県)/Kaiya Eye Clinic(Shizuoka)
10.東海眼科(三重県)/Tokai Eye Clinic (Mie)
11.佐藤裕也眼科医院(宮城県)/Yuya Sato Eye Clinic(Miyagi)
12.安藤眼科医院(神奈川県)/Ando Eye Clinic (Kanagawa)
13.レイ眼科クリニック(兵庫県)/Ray Clinic (Hyogo)
14.大塚眼科クリニック(神奈川県)/Otsuka Eye Clinic (Kanagawa)
15.みはら眼科(広島県)/Mihara Eye Clinic (Hiroshima)
16.中平眼科クリニック(岡山県)/Nakahira Eye Clinic (Okayama)
17.安里眼科おもろまち駅前(沖縄県)/ASATO Eye Clinic (Okinawa)
18.聖母眼科医院(香川県)/Seibo Ganka (Kagawa)
19.広田眼科(山口県)/Hirota EYE CLINIC(Yamaguchi)
20.高畠西眼科(岡山県)/Takabatake "West" Eye Clinic(Okayama)
21.近藤眼科グループ(東京都)/Kondo eye Institute (Tokyo)
22.慶應義塾大学医学部眼科学教室(東京都)/Dept. of Ophthalmology, Keio University (Tokyo)
23.京都府立医科大学附属病院眼科(京都府)/Dept. of Ophthalmology, Kyoto Prefectural University of Medicine (Kyoto)
24.聖路加国際病院眼科(東京都)/Dept. of Ophthalmology, St. Luke's International Hospital. (Tokyo)
2016 | Year | 04 | Month | 01 | Day |
http://jglobal.jst.go.jp/public/20090422/201502200163389940
Unpublished
http://www.jscrs-lasik.org/contents/report.html
Total number of LASIK surgeries in 2013 was 71,089. Entire refractive eye surgeries comprised 94.8%.
Visual acuity (naked eye) of 1.0 or higher: 96%
Corrected visual acuity (naked eye) of 1.0 or higher: 96%
Predictability of +/-0.5D or +/-1.0: each were 93.98%
Refractive change within 1.0D: 97%
Patients satisfied with surgery: 85%
Complications before and after surgery:
1)Faulty flap made, 3 cases (0.0%)
2)Wrinkle in flap, 792 cases (1.1%)
3)Deflected flap, 4 cases (0.0%)
4)decentration, 1 case (0.0%)
5)Inner-layer opacity, 5 cases (0.0%)
6)DLK, 404 cases (0.6%)
7)Epithelial ingrowth, 13 cases (0.2%)
8)Keratectasia, 2 cases (0.0%)
9)Steroid glaucoma, 2 cases (0.0%)
10)Severe dry eye, 862 cases (1.2%)
11)Additional surgery, 1819 cases (.23%)
12)Eye infection, 0 cases (0%)
Based on the above results, we have confirmed that the safety and efficacy of LASIK performed in Japan is high and also receives high satisfaction ratings from patients.
Preinitiation
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 04 | Month | 01 | Day |
2018 | Year | 04 | Month | 30 | Day |
2018 | Year | 05 | Month | 31 | Day |
2018 | Year | 05 | Month | 31 | Day |
2018 | Year | 06 | Month | 30 | Day |
1.Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea 2007;26:246-54
2.Solomon KD, Fernandez de Castro LE, Sandoval HP, Biber JM, Gr oat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701
2016 | Year | 04 | Month | 01 | Day |
2022 | Year | 10 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025080
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