UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025203 |
|---|---|
| Receipt number | R000028951 |
| Scientific Title | Evaluation of anterior segment inflammation in HOYA IOL iSert micro255 inserted eyes. |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2019/05/28 18:58:25 |
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Basic information
Public title
Evaluation of anterior segment inflammation in HOYA IOL iSert micro255 inserted eyes.
Acronym
Evaluation of anterior segment inflammation in HOYA IOL iSert micro255 inserted eyes.
Scientific Title
Evaluation of anterior segment inflammation in HOYA IOL iSert micro255 inserted eyes.
Scientific Title:Acronym
Evaluation of anterior segment inflammation in HOYA IOL iSert micro255 inserted eyes.
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long-term, prospective and quantitative evaluation of postoperative anterior segment inflammation after implantation of an IOL manufactured under revised process.
Basic objectives2
Others
Basic objectives -Others
To track the level of anterior segment inflammation via anterior chamber flare scores and cell scores throughout the one-year observation period.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Laser flare meter quantification of anterior chamber flare and manual anterior chamber inflammation scoring under slit lamp examination.
Key secondary outcomes
Corrected visual acuity, corneal endothelial cell density, intraocular pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Examination group: HOYA IOL iSert255
Interventions/Control_2
Control group; Alcon Acrysof IQ
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
1)Patients with bilateral senile cataract planned for elective cataract surgery (Age; 40 years old and above).
2)Calculated IOL power to be within the applicable range of the product.
3)Estimated postoperative corrective visual acuity; over 20/40.
4)Likely to fulfill all scheduled postoperative visits.
Key exclusion criteria
1)Active inflammatory conditions (Ocular/systemic)
2)Trauma induced cataract, diabetes mellitus, diabetic retinopathy, pseudoexfoliation syndrome, glaucoma, uveitis, rubeosis iridis, retinal detachment
3)amblyopia,congenital ocular diseases
4)Fuchs' corneal dystrophy or other severe corneal dystrophy
5)Secondary IOL implantation
6)Severe intraoperative complications with potential to affect postoperative visual acuity, including anterior capsule tear, decentered capsulorrhexis, posterior capsule rupture, vitreous prolapse, zonular dialysis.
7)History of corneal transplant
8)Conditions interpreted as incompatible with the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eguchi Shuichiro, Miyata Kazunori |
Organization
Eguchi eye hospital, Miyata eye hospital
Division name
Eguchi eye hospital, Miyata eye hospital
Zip code
Address
7-13 Suehirocho, Hakodate, Hokkaido, Postal code 040-0053/ 6-3 Kuhara, Miyakonojo, Miyazaki. Postal code 885-0051
TEL
0138-23-2272
koh-sasaki@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sasaki Koh |
Organization
Eguchi eye hospital
Division name
Eguchi eye hospital
Zip code
Address
7-13 Suehirocho, Hakodate, Hokkaido
TEL
0138-23-2272
Homepage URL
koh-sasaki@umin.ac.jp
Sponsor or person
Institute
Eguchi eye hospital, Miyata eye hospital
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)
HOYA Corporation
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Eguchi eye hospital, Miyata eye hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
江口眼科病院（北海道）、宮田眼科病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2019 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028951
| Research Plan | |
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| Registered date | File name |
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