UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033629
Receipt No. R000038332
Scientific Title Comparison of intraocular lens location after Phacovitrectomy and Cataract surgery
Date of disclosure of the study information 2018/08/06
Last modified on 2020/08/04 (Ver. 6)

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Basic information
Public title Comparison of intraocular lens location after Phacovitrectomy and Cataract surgery
Acronym IOL location after phacovitrectomy
Scientific Title Comparison of intraocular lens location after Phacovitrectomy and Cataract surgery
Scientific Title:Acronym 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 2 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 Sixty patients who are scheduled for phacovitrectomy are randomly assigned to one of two groups.
Interventions/Control_2 One of 2 kinds of single-piece intraocular lenses are implanted to each group. Sixty 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 Sixty eyes of consecutive 60 patients who are scheduled for phacovitrectomy. Sixty eyes of consecutive 60 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 60

Research contact person
Name of lead principal investigator
1st name Tatsuhiko
Middle name
Last name Sato
Organization Hayashi Eye Hospital
Division name Department of Ophthalmology
Zip code 8120011
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
1st name Tatsuhiko
Middle name
Last name Sato
Organization Hayashi Eye Hospital
Division name Department of Ophthalmology
Zip code 8120011
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)

IRB Contact (For public release)
Organization Institutional Review Board of Hayashi Eye Hospital
Address 4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
Tel 092-431-1680
Email mihara-seiya@hayashi.or.jp

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

Related information
URL releasing protocol https://www.sciencedirect.com/science/article/abs/pii/S2468653020300427?via%3Dihub
Publication of results Unpublished

Result
URL related to results and publications https://www.sciencedirect.com/science/article/abs/pii/S2468653020300427?via%3Dihub
Number of participants that the trial has enrolled 120
Results 
Neither myopic shift nor IOL displacement occurs after 25-gauge phacovitrectomy with a single-piece IOL without gas injection for macular pathology compared with phacoemulsification alone.
Results date posted
2020 Year 08 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Good
Participant flow 
Good
Adverse events 
None
Outcome measures 
IOL location, refractive error
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 07 Month 31 Day
Date of IRB
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

Other
Other related information

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2020 Year 08 Month 04 Day


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