UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042733
Receipt number R000048769
Scientific Title Clinical outcomes of scleral intraocular lens fixation
Date of disclosure of the study information 2020/12/17
Last modified on 2021/12/13 21:03:46

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Basic information

Public title

Clinical outcomes of scleral intraocular lens fixation

Acronym

Clinical outcomes of scleral intraocular lens fixation

Scientific Title

Clinical outcomes of scleral intraocular lens fixation

Scientific Title:Acronym

Clinical outcomes of scleral intraocular lens fixation

Region

Japan


Condition

Condition

aphakia, intralocular lens dislocation, lens dislocation

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To report the clinical outcomes of intrascleral fixation of an intraocular lens

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intraocular lens dislocation, tilt

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The intraocular lens haptic is pulled out of the sclera by the single needle method.

Interventions/Control_2

The intraocular lens haptic is pulled out of the sclera by the double needle method.

Interventions/Control_3

The intraocular lens haptic is pulled out of the sclera by the vitreous forceps.

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

120 years-old >

Gender

Male

Key inclusion criteria

Patients in which visual function is impaired due to aphakia, intraocular lens dislocation, lens dislocation.

Key exclusion criteria

The exclusion criteria were retinal disease requiring treatment, such as retinal detachment or macular pucker; preoperative intraocular pressure (IOP) of 25 mmHg or more while receiving treatment with eye drops; scleritis;
age younger than 20 years

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tatsushi
Middle name
Last name Kaga

Organization

Chukyo Hospital

Division name

Opthalomology

Zip code

4578510

Address

1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aichi

TEL

052-691-7151

Email

kaga@chukyogroup.jp


Public contact

Name of contact person

1st name Hayato
Middle name
Last name Mitamura

Organization

Chukyo Hospital

Division name

Opthalomology

Zip code

4578510

Address

1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aichi

TEL

052-691-7151

Homepage URL


Email

mitamura@chukyogroup.jp


Sponsor or person

Institute

Chukyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Chukyo Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Community Health care Organization

Address

1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aic

Tel

052-691-7151

Email

mitamura@chukyogroup.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2020019

Org. issuing International ID_1

Chukyo Hospital

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 12 Month 17 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

63

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

Open public recruiting

Date of protocol fixation

2020 Year 12 Month 17 Day

Date of IRB

2020 Year 06 Month 25 Day

Anticipated trial start date

2020 Year 12 Month 17 Day

Last follow-up date

2022 Year 12 Month 17 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 12 Month 12 Day

Last modified on

2021 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048769


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name