UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on macular pigment optical density and macular functional changes in pseudophakic eyes
Title of the study (Brief title)	Macular pigment optical density in pseudophakic eyes
Region	Japan

Condition
Condition	Cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate macular pigment optical density and macular functions in pseudophakic eyes
Basic objectives2	Others
Basic objectives -Others	To investigate the influence of intra ocular lens on the macular function
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Macular pigment optical density 2)Electroretinography(ERG) of the macular area Measurement: One-day, one month, three months, six months, and twelve months after the operation
Key secondary outcomes	1) Visual acuity 2) Intra ocular pressure 3) Contrast and glare sensitivity 4) Retinal morphology

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
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Yellow tinted intra ocular lens HOYA PY-60AD HOYA NY-60
Interventions/Control_2	Non-tinted intra ocular HOYA PC-60AD Alcon SA60AT
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	Patients who meet the following inclusion criteria: 1)With the prior written consent 2)Japanese 3)Patients to be qualified for this study based on the test results by the physician
Key exclusion criteria	1) Eyes with severe retinal diseases 2) Patients who request a specific intra ocular lens to be implanted 3) Eyes with difficulty of macular pigment measurement 4) Minority/person under age
Target sample size	100

Research contact person
Name of lead principal investigator	Akira Obana
Organization	Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name	Ophthalmology
Address	2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka Pref. 430-8558
TEL	053-474-2222
Email	webmaster@sis.seirei.or.jp

Public contact
Name of contact person	Ophthalmology
Organization	Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name	Ophthalmology
Address	2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka Pref. 430-8558
TEL	053-474-2222
Homepage URL
Email	webmaster@sis.seirei.or.jp

Sponsor
Institute	Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)
Institute
Department

Funding Source
Organization	HOYA Corporation Medical division
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Shimane University (Shimane Prefecture)
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	聖隷浜松病院（静岡県）

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 09 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2012 Year 07 Month 01 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	2010 Year 04 Month 23 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004280