UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023618 |
|---|---|
| Receipt number | 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 17:08:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ymuraka3@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027200
