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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021744
Receipt No. 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 2016/05/09

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Basic information
Public title Evaluation of the safety and efficacy of LASIK surgery using a survey on the degree of satisfaction after long term LASIK surgery
Acronym A survey on the degree of satisfaction after long term LASIK surgery
Scientific Title Evaluation of the safety and efficacy of LASIK surgery using a survey on the degree of satisfaction after long term LASIK surgery
Scientific Title:Acronym A survey on the degree of satisfaction after long term LASIK surgery
Region
Japan

Condition
Condition Post LASIK surgery
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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 secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 questionnaire survey 1 year after LASIK surgery
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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).
Key exclusion 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&#39;s visit form upon request
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Yoshino
Organization Yoshino Eye Clinic
Division name Dept. of Ophthalmology
Zip code
Address 1-20-10 Ueno, Taito-ku, Fugetsudo Bldg. 6F, Tokyo 110-0005 Japan
TEL 03-3839-5092
Email yoshino.eye.clinic.kenichi@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimiko Nakabayashi
Organization LASIK Safety Network
Division name Secretary
Zip code
Address 2-26-35, 8F, Minamiaoyama, Minato-ku, Tokyo 107-0062 Japan
TEL 03-5775-6070
Homepage URL
Email inquiries@safety-lasik.net

Sponsor
Institute Yoshino Eye Clinic
Institute
Department

Funding Source
Organization LASIK Safety Network
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 Day

Related information
URL releasing protocol http://jglobal.jst.go.jp/public/20090422/201502200163389940
Publication of results Unpublished

Result
URL related to results and publications http://www.jscrs-lasik.org/contents/report.html
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 05 Month 31 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information 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

Management information
Registered date
2016 Year 04 Month 01 Day
Last modified on
2016 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025080

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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