UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037993 |
|---|---|
| Receipt number | R000043305 |
| Scientific Title | Recording electroretinogram of postoperative inflammation after cataract surgery with RETeval system |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2024/03/16 20:56:44 |
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Basic information
Public title
Recording electroretinogram of postoperative inflammation after cataract surgery with RETeval system
Acronym
Electroretinogram during perioperative cataract surgery
Scientific Title
Recording electroretinogram of postoperative inflammation after cataract surgery with RETeval system
Scientific Title:Acronym
CAT-ERG
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We recorded flicker ERGs from patients who are going to take cataract surgery. ERGs will be recorded according to the schedule. We are going to examine if we can evaluate postoperative inflammation with ERGs recorded by RETeval system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in implicit times and amplitude of flicker ERGs.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are going to take cataract surgery at department of Ophthalmology of Mie University hospital.
Key exclusion criteria
Diabetes mellitus, epiretinal membrane, pseudoexfoliation syndrome, retinal vein occlusion, uveitis, glaucoma, retinal degenerative disorder.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Kato |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-1111
ganka@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Kato |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-1111
Homepage URL
ganka@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Encouragement of study donation (other than a company)
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
Research and Development Center of Mie University Hospital
Address
2-174, Edobashi, Tsu, Mie
Tel
059-231-5246
kk-sien@mo.medic.mie-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
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R00004330
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2666914522001324
Number of participants that the trial has enrolled
32
Results
A transient increase in the amplitude of the flicker ERG was found after lens reconstruction surgery. The increase in amplitude of the flicker ERG was statistically significantly associated with an increase in central retinal thickness, suggesting that the increase in ERG amplitude is likely to represent intraocular inflammation.
Results date posted
| 2024 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who undergoing cataract surgery.
Participant flow
After lens reconstruction, the patient was followed up over a 3-month period.
Adverse events
None
Outcome measures
Flicker ERG,
aqueous flare value, central macular thickness
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are going to examine the patients with flicker ERG, OCT, aqueous flare.
Management information
Registered date
| 2019 | Year | 09 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043305
| 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 |
