UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018771
Receipt number R000021715
Scientific Title Long-term Comparison of Posterior Chamber Phakic Intraocular Lens with and without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism.
Date of disclosure of the study information 2015/08/23
Last modified on 2015/08/23 12:20:58

* 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

Public title

Long-term Comparison of Posterior Chamber Phakic Intraocular Lens with and without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism.

Acronym

Long-term Comparison of Hole ICL and Conventional ICL

Scientific Title

Long-term Comparison of Posterior Chamber Phakic Intraocular Lens with and without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism.

Scientific Title:Acronym

Long-term Comparison of Hole ICL and Conventional ICL

Region

Japan


Condition

Condition

Moderate to High Myopia and Myopic Astigmatism.

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the long-term clinical outcomes of implantation of the posterior chamber phakic intraocular lens (Visian ICLTM, STAAR Surgical) with and without a central artificial hole for moderate to high ametropia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Before, 1, 3 and 6 months, and 1, 3, and 5 years after surgery, we assessed safety, efficacy, predictability, stability, intraocular pressure, lens density, and adverse events of the two surgical techniques.

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


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

Posterior Chamber Phakic Intraocular Lens with a Central Hole

Interventions/Control_2

Posterior Chamber Phakic Intraocular Lens without a Central Hole

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

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Moderate to high myopia (manifest spherical equivalent -4.00 diopter (D) or more)

Key exclusion criteria

Eyes with keratoconus were excluded from the study by using the keratoconus screening test of Placido disk videokeratography.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kimiya Shimizu

Organization

University of Kitasato School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.

TEL

+81-42-778-8464

Email

kimiyas@med.kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazutaka Kamiya

Organization

University of Kitasato School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan.

TEL

+81-42-778-8464

Homepage URL


Email

kamiyak-tky@umin.ac.jp


Sponsor or person

Institute

University of Kitasato School of Medicine

Institute

Department

Personal name



Funding Source

Organization

This work was supported in part by Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan (24592642).

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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

2015 Year 08 Month 23 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

2010 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 01 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

2015 Year 08 Month 23 Day

Last modified on

2015 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021715


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name