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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025203
Receipt No. 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

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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
Email 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
Email koh-sasaki@umin.ac.jp

Sponsor
Institute Eguchi eye hospital, Miyata eye hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028951

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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