UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058261 |
|---|---|
| Receipt number | R000066601 |
| Scientific Title | A Single-Center Retrospective Study on the Causal Relationships Between Preoperative Ocular Parameters and Surgical Techniques and Postoperative Outcomes in Phakic Intraocular Lens Implantation |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/24 12:21:13 |
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Basic information
Public title
Investigation of the causal relationship between preoperative factors, surgical techniques, and postoperative outcomes in phakic intraocular lens implantation
Acronym
Investigation of the causal relationship between preoperative factors, surgical techniques, and postoperative outcomes in phakic intraocular lens implantation
Scientific Title
A Single-Center Retrospective Study on the Causal Relationships Between Preoperative Ocular Parameters and Surgical Techniques and Postoperative Outcomes in Phakic Intraocular Lens Implantation
Scientific Title:Acronym
Retrospective Single-Center Study on Factors Influencing Outcomes After Phakic IOL Implantation
Region
| Japan |
Condition
Condition
Myopia/Myopic astigmatism, Hyperopia/Hyperopic astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By investigating the causal relationships between preoperative ocular parameters and surgical techniques-such as lens size and fixation direction-and postoperative outcomes in phakic intraocular lens implantation, this study aims to identify tendencies associated with increased risk of postoperative complications such as angle closure and lens-crystalline lens contact, thereby enhancing surgical safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the positional relationship between the implanted lens and ocular structures, as measured by anterior segment optical coherence tomography (AS-OCT) at least one month postoperatively.
Key secondary outcomes
Visual acuity, refractive error, intraocular pressure, corneal endothelial cell density, and accommodative function.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited our institution for phakic intraocular lens implantation and subsequently underwent the procedure.
Key exclusion criteria
Cases with a history of other ocular diseases such as cataract, glaucoma, or uveitis, which were deemed unsuitable for surgery, as well as those in which adequate preoperative or postoperative examinations could not be performed.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Shuntaro |
| Middle name | |
| Last name | Tsunehiro |
Organization
Sanno Hospital
Division name
Eye Center
Zip code
107-0052
Address
8-10-16 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-3402-3151
shuntaro.t@ihwg.jp
Public contact
Name of contact person
| 1st name | Shuntaro |
| Middle name | |
| Last name | Tsunehiro |
Organization
Sanno Hospital
Division name
Eye Center
Zip code
107-0052
Address
8-10-16 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-3402-3151
Homepage URL
shuntaro.t@ihwg.jp
Sponsor or person
Institute
Sanno Hospital Eye Center
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 Institutional Review Board
Address
8-10-16 Akasaka, Minato-ku, Tokyo, Japan
Tel
03-3402-3151
t-mimura@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
| 2025 | Year | 06 | Month | 25 | 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
| 2025 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a retrospective cohort study. We included all patients who visited the Eye Center at Sanno Hospital after September 2020 seeking phakic intraocular lens implantation and who met the inclusion criteria.
Management information
Registered date
| 2025 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066601
