UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized prospective study on refraction error in cataract vitrectric simultaneous surgery
Title of the study (Brief title)	Randomized prospective study on refraction error in cataract vitrectric simultaneous surgery
Region	Japan

Condition
Condition	Epiretinal membrane. Macular hole
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the target refractive error for one-piece intraocular lens and three piece intraocular lens insertion for the Epiretinal membrane and the macular hole, which is an indication for vitreous surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Postoperative refraction and visual acuity change Changes in anterior chamber depth after surgery Changes in intraocular pressure after surgery Changes in intraventricular inflammation after surgery One week, one month, three months, six months, one year after surgery
Key secondary outcomes

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	Postoperative refraction error when 1-piece intraocular lens is inserted in simultaneous operation of cataract vitreous body
Interventions/Control_2	Postoperative refraction error when 3-piece intraocular lens is inserted in simultaneous operation of cataract vitreous body
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	Patient who went to the ophthalmology department of Wakayama Medical University Hospital for ophthalmology or who is hospitalized and who undergoes vitreous surgery combined with cataract surgery, and explained the content of the research with the document and verbally acknowledged in writing. The target disease is the Epiretinal Membrane and macular hole.
Key exclusion criteria	Those who have not undergone surgery before this surgery Persons judged by the attending physician to be inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Takayoshi Sumioka
Organization	Wakayama medical university
Division name	Department of opthalmology
Address	811-1 kimiidera,wakayama
TEL	0734472300
Email	sumioka@wakayama-med.ac.jp

Public contact
Name of contact person	Akihiro Inoue
Organization	Wakayama medical university
Division name	Department of opthalmology
Address	811-1 kimiidera,wakayama
TEL	0734472300
Homepage URL
Email	ainoue@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical university
Institute
Department

Funding Source
Organization	Wakayama medical university
Organization
Division
Category of Funding Organization	Other
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 12 Month 01 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
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 11 Month 24 Day
Last modified on	2016 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028728