UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024550
Receipt number R000027744
Scientific Title Comparison of anterior staining fluids in cataract surgery
Date of disclosure of the study information 2016/10/24
Last modified on 2016/10/24 20:30:16

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Basic information

Public title

Comparison of anterior staining fluids in cataract surgery

Acronym

Effect on the corneal endothelium of the staining fluids

Scientific Title

Comparison of anterior staining fluids in cataract surgery

Scientific Title:Acronym

Effect on the corneal endothelium of the staining fluids

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate potential toxicity of two staining fluids of trypan blue (hereinafter, TB) and Brilliant Blue G (hereinafter, BBG) to corneal endothelial cells. Both fluids are used for anterior capsule staining intraoperative time

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The completion rate of successive continuous circular capsulorrhexis (hereinafter,CCC) during cataract surgery along with the corrected vision (logMAR), reduced corneal endothelial cell count (ECD), and change in central corneal thickness (CCT) prior to and following cataract surgery were compared.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

BSS 1.0 ml was injected into the anterior chamber for the CT group.

Interventions/Control_2

BBG 1.0 ml was injected injected into the anterior chamber for the BBG group.
The concentration of BBG was 0.1%

Interventions/Control_3

TB 1.0 ml was injected injected into the anterior chamber for the TB group.
The concentration of TB was 0.1%

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

People with cataract

Key exclusion criteria

Patients with a history of internal eye surgery such as vitreous surgery, etc., or a history of corneal diseases such as corneal endothelial inflammation, interstitial keratitis, etc., that included the fellow eye were excluded. Moreover, cases with a corneal endothelial count of less than 2000/mm2 during preoperative evaluation, cases of mature cataract and cases in which extracapsular cataract extraction/intracapsular cataract extraction were carried out during surgery. Further, cases in which the patient discontinued consultation during the 6 months of the postoperative follow-up period were also excluded.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takamitsu Nagashima

Organization

Department of Ophthalmology Saitama Medical University

Division name

Ophthalmology

Zip code


Address

38 Morohongo Moroyama-machi, Iruma, Saitama 350-0495, Japan

TEL

+81-49-276-1125

Email

howdoyoulikechosan1027@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Takamitsu Nagashima

Organization

Department of Ophthalmology Saitama Medical University

Division name

Ophthalmology

Zip code


Address

38 Morohongo Moroyama-machi, Iruma, Saitama 350-0495, Japan

TEL

+81-49-276-1125

Homepage URL


Email

howdoyoulikechosan1027@gmail.com


Sponsor or person

Institute

Department of Ophthalmology,Yokohama Minami Kyousai Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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


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

2016 Year 10 Month 24 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

2015 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 24 Day

Last modified on

2016 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027744


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name