UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055098 |
|---|---|
| Receipt number | R000062947 |
| Scientific Title | Examination of postoperative outcomes of OVD-free ICL surgery |
| Date of disclosure of the study information | 2024/07/29 |
| Last modified on | 2024/07/29 15:00:10 |
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Basic information
Public title
Examination of postoperative outcomes of OVD-free ICL surgery
Acronym
Examination of postoperative outcomes of OVD-free ICL surgery
Scientific Title
Examination of postoperative outcomes of OVD-free ICL surgery
Scientific Title:Acronym
Examination of postoperative outcomes of OVD-free ICL surgery
Region
| Japan |
Condition
Condition
Refractive errors
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to confirm the safety of performing ICL surgery without using an OVD and to improve the overall outcome of surgery.
The results of this study are expected to clarify the risks of using or not using an OVD during ICL surgery, improve the safety and effectiveness of surgery, and increase patient satisfaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Patient background
Age, sex, operated eye, presence or absence of eye disease
2) Examination items
1. Preoperative examination items: naked eye visual acuity, corrected visual acuity, subjective spherical equivalent, corneal refractive power, intraocular pressure, axial length, number of corneal endothelial cells, distance between the corneal base and the angle
2. Intraoperative observation items: position of main incision, time required for surgery, presence or absence of intraoperative complications, etc.
3. Postoperative observation items: naked eye visual acuity, corrected visual acuity, subjective spherical equivalent, corneal refractive power, intraocular pressure, number of corneal endothelial cells, distance between ICL and lens (vault), postoperative complications, etc.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ICL surgery without the use of an OVD at Sanno Hospital Eye Center after April 2024 and were able to undergo postoperative follow-up. The control group consisted of patients who underwent ICL surgery using an OVD between April 2016 and March 2024.
1) Patients with ICL insertion (regardless of the lens strength, size, or presence or absence of a through hole used)
2) Patients who were able to undergo postoperative follow-up for at least one month, regardless of whether an OVD was used or not
Key exclusion criteria
Exclusion criteria
1) Patients with postoperative corrected visual acuity of less than 0.8
2) Patients with diseases that affect visual function other than refractive errors, such as cataracts, severe dry eye, macular degeneration, and glaucoma
3) Patients who are otherwise deemed inappropriate by the attending physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Takahashi |
Organization
Sanno Hospital
Division name
Ophthalmology
Zip code
107-0052
Address
8-10-16 Akasaka, Minato-ku, Tokyo
TEL
0334023151
zavide96@gmail.com
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Takahashi |
Organization
Sanno Hospital
Division name
Ophthalmology
Zip code
107-0052
Address
8-10-16 Akasaka, Minato-ku, Tokyo
TEL
0334023151
Homepage URL
m-hide@iuhw.ac.jp
Sponsor or person
Institute
Sanno Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Junwakai IRB
Address
8-10-16 Akasaka, Minato-ku, Tokyo
Tel
0334023151
m-hide@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted in compliance with the Declaration of Helsinki and the Ethical Guidelines for Scientific and Medical Research Involving Human Subjects (enforced June 30, 2021).
Management information
Registered date
| 2024 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062947
