UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038359 |
|---|---|
| Receipt number | R000043717 |
| Scientific Title | Evaluation of effect of Implantable contact lens (ICL) implantation on intraocular lens power calculation for cataract surgery. |
| Date of disclosure of the study information | 2019/10/23 |
| Last modified on | 2022/09/19 23:53:33 |
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Basic information
Public title
Evaluation of effect of Implantable contact lens (ICL) implantation on intraocular lens power calculation for cataract surgery.
Acronym
Effect of ICL on IOL power calculation
Scientific Title
Evaluation of effect of Implantable contact lens (ICL) implantation on intraocular lens power calculation for cataract surgery.
Scientific Title:Acronym
Effect of ICL on IOL power calculation
Region
| Japan |
Condition
Condition
ametropia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the effect of implantable contact lens insertion for correcting myopia on the power calculation of intraocular lens using in cataract surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal refractive power, Ocular axial length, anterior chamber depth, lens thickness, estimated IOL power of before and after ICL implantation
Key secondary outcomes
Corneal astigmatism, objective refractive error of before and after ICL implantation
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
| Maneuver |
Interventions/Control_1
Implantable contact lens insertion for correcting myopia or myopic astigmatism
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent Implantable contact lens insertion for correcting myopia or myopic astigmatism from 2019 to 2020, and observed more than three months after surgery.
Key exclusion criteria
Cases with intraoperative complication
Target sample size
20
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
0756625660
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
0756625660
Homepage URL
mouchi@skyblue.ocn.ne.jp
Sponsor or person
Institute
Masayuki Ouchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Masayuki Ouchi Eye Clinic
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
Masayuki Ouchi Eye Clinic
Address
9 Nishikujo Ohkuni-cho Minami-ku, Kyoto 601-8449, Japan
Tel
0756625660
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
大内雅之アイクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
https://journals.lww.com/jcrs/pages/results.aspx?txtKeywords=MASAYUKI+OUCHI
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/jcrs/pages/results.aspx?txtKeywords=MASAYUKI+OUCHI
Number of participants that the trial has enrolled
100
Results
The estimated IOL power was significantly lower at post-pIOL implantation according to the H and B formulae (both p < 0.001) but remained unchanged by the S formula. However, no difference was observed when AS-OCT-derived ACD and lens thickness (LT) values were introduced in the H (p = 0.16) and B (p = 0.55) formulae.
Results date posted
| 2022 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Myopic eyes
Participant flow
pre operative examination
ICL implant surgery
Post operative examination
Adverse events
none
Outcome measures
Biometry
IOL power calculation using SRK/T (S), Haigis (H), and Barret Universal (B) formulae
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 22 | Day |
Last modified on
| 2022 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043717
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
