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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023618
Receipt No. R000027200
Scientific Title Comparison of posterior capsule opacification between 2 intraocular lenses in cataract patients associated with retinitis pigmentsa
Date of disclosure of the study information 2016/09/01
Last modified on 2018/10/01

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Basic information
Public title Comparison of posterior capsule opacification between 2 intraocular lenses in cataract patients associated with retinitis pigmentsa
Acronym Posterior capsule opacification in patients with retinitis pigmentosa
Scientific Title Comparison of posterior capsule opacification between 2 intraocular lenses in cataract patients associated with retinitis pigmentsa
Scientific Title:Acronym Posterior capsule opacification in patients with retinitis pigmentosa
Region
Japan

Condition
Condition Cataract associated with patients with retinitis pigmentosa
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the posterior capsule opacification between 1-piece and 3-piece intraocular lenses in a 1 year follow-up after cataract surgery in patients with retinitis pigments
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The severity of posterior capsule opacification evaluated by POCOman software at 1 year after cataract surgery
Key secondary outcomes 1) The severity and incidence of posterior capsule opacification evaluated by slit-lamp ophthalmoscope. 2) The severity of anterior capsule opacification, 3) The incidence of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Cataract surgery and implantation of 1P intraocular lens (PCB00V)
Interventions/Control_2 Cataract surgery and implantation of 3P intraocular lens (VA-70AD)
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who were more than 40 years-old
2. Patients who have cataract and retinitis pigmentosa
3. No prior intraocular surgery
4. Patients who are able to consent the study and cooperate in the examination after surgery.
5. No adverse events during cataract surgery
6. No severe systemic complications such as uncontrolled diabetes mellitus
Key exclusion criteria 1. Patients who have ocular complications that can cause retinal abnormalities similar to retinitis pigmentsa
2. Patients who are in serious systemic conditions, including severe heart failure and uncontrolled diabetes mellitus.
3. Patients deemed inadequate for the study by the principal investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koh-hei Sonoda
Organization Graduate School of Medical Sciences, Kyushu University
Division name Dept of Ophthalmology
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL 092-642-5648
Email sonodak@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Murakami
Organization Kyushu University Hospital
Division name Dept of Ophthalmology
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
TEL 092-642-5648
Homepage URL
Email ymuraka3@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Abbott Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 09 Month 01 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 Terminated
Date of protocol fixation
2016 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 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 08 Month 14 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027200

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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