UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048964 |
|---|---|
| Receipt number | R000047832 |
| Scientific Title | Clinical outcome of vertical fixation of Implantable Collamer Lens |
| Date of disclosure of the study information | 2022/09/20 |
| Last modified on | 2025/03/30 23:39:55 |
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Basic information
Public title
Clinical outcome of vertical fixation of Implantable Collamer Lens
Acronym
Clinical outcome of vertical fixation of Implantable Collamer Lens
Scientific Title
Clinical outcome of vertical fixation of Implantable Collamer Lens
Scientific Title:Acronym
Clinical outcome of vertical fixation of Implantable Collamer Lens
Region
| Japan |
Condition
Condition
ametropia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate postoperative outcome and conditions of vertical fixation of posterior chamber phakic intraocular lens (Visian ICL).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compared postoperative refractive error, anterior chamber depth, vault between actual data and estimated value with N-K formula or K-S formula
Key secondary outcomes
We compared postoperative refractive error, anterior chamber depth, vault between eyes with vertical ICL fixation and horizontal ICL fixation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Eyes underwent ICL implantation with vertical fixation
Interventions/Control_2
Eyes underwent ICL implantation with horizontal fixation
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eyes underwent ICL implantation for myopia or myopic astigmatism without ophthalmological diseases other than refractive error
Key exclusion criteria
Eyes with ophthalmological diseases other than refractive error
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ouchi |
Organization
Masayuki Ouchi Eye Clinic
Division name
Ophthalmology
Zip code
6018449
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto 601-8449, Japan
TEL
075-662-5660
mouchi@skyblue.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ouchi |
Organization
Masayuki Ouchi Eye Clinic
Division name
Ophthalmology
Zip code
6018449
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto 601-8449, Japan
TEL
075-662-5660
Homepage URL
mouchi@skyblue.ocn.ne.jp
Sponsor or person
Institute
Masayuki Ouchi Eye Clinic
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
Institutional Review Board of Masayuki Ouchi Eye Clinic
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto 601-8449, Japan
Tel
075-662-5660
mouchi@skyblue.ocn.ne.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
| 2022 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-024-52913-8
Publication of results
Unpublished
Result
URL related to results and publications
https://www.nature.com/articles/s41598-024-52913-8
Number of participants that the trial has enrolled
200
Results
values were slightly lower than the predicted values immediately after the operation.
Results date posted
| 2025 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 180 right eyes of 180 patients who underwent ICL (STAAR Surgical Co., Monrovia, CA, USA) implantation using the model V4c for myopia or myopic astigmatism between January 2021 and January 2023
Participant flow
Patient selection
Patients were divided into the following two groups: all toric cases were assigned to a horizontal group and all non-toric cases were assigned to either a horizontal or vertical group using the envelope method. Case enrollment was continued until both groups reached 90 eyes each.
Adverse events
none
Outcome measures
Outcome measurements
Visual acuity, subjective refraction, objective refraction, and intraocular pressure were examined before surgery, and 1 day, 1 week, and 1 month after surgery. A-OCT was performed before surgery, and 2 h (2h), and 1 day (1d), 1 week (1w), and 1 month after surgery (1m) to measure ACD and vault. A-OCT scanning was performed in the horizontal direction, and the prediction formula described later was the initial setting calculated from the horizontal white-to-white (WTW) and angle-to-angle (ATA) distances. The ACD was detected by measuring the distance from the corneal endothelium to the anterior surface of the lens, and the postoperative ACD was measured by manually tracing from the corneal endothelium to the anterior surface of the lens. The ACD, vault, and their changes over time in each group were compared between the two groups. The difference between the preoperative predicted vault in the selected size ICL and the postoperative actual measurement in each eye was examined in the two groups. The predicted vault before surgery was calculated using the KS formula version 4, which is a prediction formula installed in A-OCT.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047832
