UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029258
Receipt number R000033442
Scientific Title Piggyback Implantable Collamer Lens Implantation for the Correction of Residual Refractive Errors after Cataract Surgery. A Multicenter Study.
Date of disclosure of the study information 2017/10/01
Last modified on 2019/01/29 09:08:58

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Basic information

Public title

Piggyback Implantable Collamer Lens Implantation for the Correction of Residual Refractive Errors after Cataract Surgery. A Multicenter Study.

Acronym

Outcomes of piggyback ICL implantation after cataract surgery.

Scientific Title

Piggyback Implantable Collamer Lens Implantation for the Correction of Residual Refractive Errors after Cataract Surgery. A Multicenter Study.

Scientific Title:Acronym

Outcomes of piggyback ICL implantation after cataract surgery.

Region

Japan


Condition

Condition

Refractive errors

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the clinical outcomes of Visian ICL (STAAR Surgical, Inc.) implantation as a piggyback intraocular lens for the correction of residual refractive errors after cataract surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

uncorrected visual acuity, corrected visual acuity, refraction, adverse events

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Piggyback ICL implantation

Interventions/Control_2


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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Piggyback ICL implantation

Key exclusion criteria

Other eye diseases

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazutaka Kamiya

Organization

Kitasato University

Division name

Dept of Opthalmology

Zip code


Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa

TEL

0427788464

Email

kamiyak-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazutaka Kamiya

Organization

Kitasato University

Division name

Dept of Opthalmology

Zip code


Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa

TEL

0427788464

Homepage URL


Email

kamiyak-tky@umin.ac.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Kitasato University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 23 Day

Last modified on

2019 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033442


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name