UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033629
Receipt number 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 13:06:59

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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 or person

Institute

Hayashi Eye Hospital

Institute

Department

Personal name



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

Value
https://center6.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