UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of posterior capsule opacification between 2 intraocular lenses in cataract patients associated with retinitis pigmentsa
Title of the study (Brief title)	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	Koh-hei Sonoda
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Dept of Ophthalmology
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	Yusuke Murakami
Organization	Kyushu University Hospital
Division name	Dept of Ophthalmology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 08 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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