UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045379 |
|---|---|
| Receipt number | R000051819 |
| Scientific Title | Examination of each parameter centered on lens (IOL) tilt and decentration before and after cataract surgery in exfoliation syndrome using anterior segment optical coherence tomography CASIA2 |
| Date of disclosure of the study information | 2021/09/06 |
| Last modified on | 2025/05/01 20:09:03 |
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Basic information
Public title
Examination of each parameter centered on lens (IOL) tilt and decentration before and after cataract surgery in exfoliation syndrome using anterior segment optical coherence tomography CASIA2
Acronym
Examination of each parameter centered on lens (IOL) tilt and decentration before and after cataract surgery in exfoliation syndrome using anterior segment optical coherence tomography CASIA2
Scientific Title
Examination of each parameter centered on lens (IOL) tilt and decentration before and after cataract surgery in exfoliation syndrome using anterior segment optical coherence tomography CASIA2
Scientific Title:Acronym
Examination of each parameter centered on lens (IOL) tilt and decentration before and after cataract surgery in exfoliation syndrome using anterior segment optical coherence tomography CASIA2
Region
| Japan |
Condition
Condition
Exfoliation syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantitative study of decentration and tilt of the crystalline lens and intraocular lens before and after cataract surgery for exfoliation syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the amount of decentration and tilt before and 3 months after surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with exfoliation syndrome and undergoing cataract surgery
Key exclusion criteria
Cannot measure CASIA2
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
kitasato university hospital
Division name
Ophthalmology
Zip code
2520375
Address
1-15-1 kitasato,minami,sagamihara,kanagawa
TEL
042-778-8111
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Goukon |
Organization
kitasato university hospital
Division name
Ophthalmology
Zip code
2520375
Address
1-15-1 kitasato,minami,sagamihara,kanagawa
TEL
042-778-8111
Homepage URL
hirogo@kitasato-u.ac.jp
Sponsor or person
Institute
042-778-8111
Institute
Department
Personal name
Funding Source
Organization
kitasato university hospital
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
kitasato university hospital
Address
1-15-1 kitasato,minami,sagamihara,kanagawa
Tel
042-778-8111
rinrib@med.kitasato-u.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
| 2021 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
33
Results
Eccentricity and tilt of the lens and IOL were measured using an anterior segment optical coherence tomograph (CASIA2, TOMEY) at preoperative and 3 months postoperative time points in patients with dropout syndrome who had undergone lens reconstruction. Eccentricity and tilt showed significant correlations before and after surgery. Postoperatively, eccentricity increased significantly, but tilt did not change significantly.
Results date posted
| 2025 | Year | 05 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients diagnosed with pseudoexfoliation and undergoing cataract surgery.
Selection criteria
(1) Patients undergoing cataract surgery
(2) Patients who show deposition of debris in the anterior capsule of the lens or pupillary rim under mydriasis
(3) Patients 20 years of age or older
Gender is not a criterion
Participant flow
For patients diagnosed with pseudoexfoliation and undergoing cataract surgery, anterior segment optical coherence tomography (CASIA2, TOMEY) was used to compare and analyze the degree of tilt, eccentricity and anterior chamber depth of the lens before cataract surgery and intraocular lens after surgery at preoperative and 3 months
Adverse events
Ethics application after abstract submission. Cancelled due to lack of consent.
Reported to Hospital Director and Ethics Review Committee. An apology will be posted in the outpatient consultation room, and a written apology will be mailed to the research subjects. Violation of ethical guidelines has been reported to the academic society.
Outcome measures
Measurement and comparison of lens and IOL eccentricity and tilt using anterior segment optical coherence tomography (CASIA2, TOMEY) at preoperative and 3-month postoperative time points.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study.
A patient with exfoliation syndrome who underwent cataract surgery between September 06, 2021 and March 31, 2022 at the Department of Ophthalmology, Kitasato University Hospital.
Management information
Registered date
| 2021 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051819
