UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033629
Receipt No. R000038332
Official scientific title of the study Comparison of intraocular lens location after Phacovitrectomy and Cataract surgery
Date of disclosure of the study information 2018/08/06
Last modified on 2018/08/03

* 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
Official scientific title of the study Comparison of intraocular lens location after Phacovitrectomy and Cataract surgery
Title of the study (Brief title) IOL location after phacovitrectomy
Region
Japan

Condition
Condition Posterior segment diseases, Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate dynamics of 3 kinds of single-piece intraocular lens after uneventful phacovitrectomy by swept-source anterior segment optical coherence tomography.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Measurements of intraocular lens decentration and tilt, and measurements of anterior chamber depth at 1 week, 1 months, and 3 months after surgery, using an anterior segment optical coherence tomography.
Key secondary outcomes Measurements of spherical equivalent and uncorrected/corrected distance visual acuity before surger, as well as 1 week, 1 month, and 3 months after surgery.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Ninety patients who are scheduled for phacovitrectomy are randomly assigned to one of three groups.
Interventions/Control_2 One of 3 kinds of single-piece intraocular lenses are implanted to each group. Ninety patients who are scheduled for cataract surgery are enrolled as control.
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Ninety eyes of consecutive 90 patients who are scheduled for phacovitrectomy. Ninety eyes of consecutive 90 patients who are scheduled for cataract surgery.
Key exclusion criteria Patients in which an intraocular lenses cannot be implanted in the capsular bag. Patients with weak Zinn's zonule. Patients scheduled for receiving long-acting gas or silicone oil in the vitreous cavity. Patients scheduled for extracapsular or intracapsular cataract extraction. Less than 6.0 mm pupil diameter after mydriasis. Patients not available for follow-up.
Target sample size 90

Research contact person
Name of lead principal investigator Tatsuhiko Sato
Organization Hayashi Eye Hospital
Division name Department of Ophthalmology
Address 4-23-35, Hakataekimae, Hakata-ku,Fukuoka-city,Fukuoka
TEL 092-431-1680
Email tatsusatou@hayashi.or.jp

Public contact
Name of contact person Tatsuhiko Sato
Organization Hayashi Eye Hospital
Division name Department of Ophthalmology
Address 4-23-35, Hakataekimae, Hakata-ku,Fukuoka-city,Fukuoka
TEL 092-431-1680
Homepage URL
Email tatsusatou@hayashi.or.jp

Sponsor
Institute Hayashi Eye Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 林眼科病院(福岡県)Hayashi Eye Hospital (Fukuoka)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 31 Day
Anticipated trial start date
2018 Year 08 Month 06 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
2019 Year 04 Month 30 Day
Date trial data considered complete
2019 Year 04 Month 30 Day
Date analysis concluded
2019 Year 07 Month 31 Day

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

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038332

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.