UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040437
Receipt number R000046148
Scientific Title 27-Gauge trocar-assisted sutureless intraocular lens fixation.
Date of disclosure of the study information 2020/05/18
Last modified on 2020/05/18 18:29:47

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Basic information

Public title

27-Gauge trocar-assisted sutureless intraocular lens fixation.

Acronym

27-Gauge trocar-assisted sutureless intraocular lens fixation.

Scientific Title

27-Gauge trocar-assisted sutureless intraocular lens fixation.

Scientific Title:Acronym

27-Gauge trocar-assisted sutureless intraocular lens fixation.

Region

Japan


Condition

Condition

IOL dislocation/fall, subluxated crystalline lens, aphakia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To report a novel technique for sutureless intrascleral fixation of the intraocular lens (IOL) using retinal forceps with a 27-gauge trocar.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Main outcome measures were visual acuity, corneal endothelial cell density, IOL tilt, decentration, predicted error of refraction and complications.
Follow up periodo is 1month.

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

A 27gauge trocar formed 3mm scleral tunnels positioned at 4 and 10 oclock, 2 mm from the corneal limbus. We used a 3piece IOL haptic grasped by a 27gauge retinal forceps and pulled from the 27gauge trocar. The IOL was fixed by making a flange.

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients were given diagnosis of IOL dislocation/fall, subluxated crystalline lens and aphakia.

Key exclusion criteria

The study exclusion criteria were hazy cornea or corneal scarring, aniridia, macular scarring, glaucoma and postoperative follow-up for less than 1 month.

Target sample size

19


Research contact person

Name of lead principal investigator

1st name Tatsuya
Middle name
Last name Jujo

Organization

St. Marianna University School of Medicine

Division name

Ophthalmology

Zip code

2168514

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan

TEL

0449778111

Email

t2jujo@marianna-u.ac.jp


Public contact

Name of contact person

1st name Tatsuya
Middle name
Last name Jujo

Organization

St. Marianna University School of Medicine

Division name

Ophthalmology

Zip code

2168514

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan

TEL

0449778111

Homepage URL


Email

t2jujo@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

St. Marianna University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna University School of Medicine

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan

Tel

0449778111

Email

t2jujo@marianna-u.ac.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



Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 18 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

19

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

Main results already published

Date of protocol fixation

2018 Year 07 Month 01 Day

Date of IRB

2018 Year 12 Month 03 Day

Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date

2019 Year 10 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 05 Month 18 Day

Last modified on

2020 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046148


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name