UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023081 |
|---|---|
| Receipt number | 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 | 2023/07/14 13:54:40 |
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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
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
kyamamur@koto.kpu-m.ac.jp
Sponsor or person
Institute
Baptist Eye Institute
Institute
Department
Personal name
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
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
22
Results
A paired t-test was used to examine the amount of axial length elongation for two years, and the result was 0.08mm in the LASIK group and 0.06mm in the soft contact lens group, showing no difference between the two groups. At 2.5 years after surgery, uncorrected visual acuity in the LASIK group was 1.40, corrected visual acuity was 1.57, efficacy index was 1.01, safety index was 1.15, and subjective refraction was -0.16D.
Results date posted
| 2023 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Overall: 11 males, 11 females, average age 26.0 years, preoperative subjective refraction LASIK group -6.29D, soft contact lens group -6.25D, preoperative axial length LASIK group 26.42mm,soft contact lens group26.39mm
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025897
