UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023081
Receipt No. R000025897
Scientific Title Evaluation of the effect of LASIK on axial length
Date of disclosure of the study information 2016/08/01
Last modified on 2020/07/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of the effect of LASIK on axial length
Acronym Evaluation of the effect of LASIK on axial length
Scientific Title Evaluation of the effect of LASIK on axial length
Scientific Title:Acronym Evaluation of the effect of LASIK on axial length
Region
Japan

Condition
Condition High myopia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm that LASIK prevents axial length elongation while use of contact lens does not.
Basic objectives2 Others
Basic objectives -Others To compare visual function after LASIK and wearing of contact lens.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Axial length
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 LASIK in unilateral eyes of 30 enrolled patients
Interventions/Control_2 Wearing contact lens in fellow eyes
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
34 years-old >=
Gender Male and Female
Key inclusion criteria (1)the person the degree of the nearsightedness is the equivalent spherical value- who is more than 3 D - less than 10 D
(2)both sexes by which the age is less than 34 years old more than 18 years old
(3)able-bodied person who doesn't possess an ocular disease besides the refraction abnormality
(4)the person who wears contact lens in both eyes and has a medical examination in ophthalmology periodically
(5)the person who can also understand a gist of this research with the one of the enough explanation and get consent in a document by one's own free will
Key exclusion criteria (1)keratoconus
(2)active ocular outer inflammation
(3)cataract
(4)inflammation with uveitis and scleritis
(5)the whole body with a high possibility that I have an influence on a wound healing or immunodeficient disease such as serious case's diabetes and serious case's atopic disease
(6)during pregnancy or nursing lady
(7)keratoconus suspect
(8)additionally the study person in charge judges participation in this research to be unsuitable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Yamamura
Organization Baptist Eye Institute
Division name Department of ophthalmology
Zip code 6068287
Address 12 Kamiikeda-cho Kitashirakawa Sakyo-ku Kyoto
TEL 075-721-3800
Email kyamamur@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Kiyoshi
Middle name
Last name Yamamura
Organization Baptist Eye Institute
Division name Department of ophthalmology
Zip code 6068287
Address 12 Kamiikeda-cho Kitashirakawa Sakyo-ku Kyoto
TEL 075-721-3800
Homepage URL
Email kyamamur@koto.kpu-m.ac.jp

Sponsor
Institute Baptist Eye Institute
Institute
Department

Funding Source
Organization none
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 Kyoto Prefectural University of Medicine , Clinical Review Board
Address 465 Kajii-cho Kawaramachi Kamigyo-ku Kyoto
Tel 075-251-5337
Email rinri@koto.kpu-m.ac.jp

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 バプテスト眼科クリニック(京都府)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2016 Year 05 Month 10 Day
Date of IRB
2016 Year 05 Month 10 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 08 Day
Last modified on
2020 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025897

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.