UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040710
Receipt number R000046476
Scientific Title Measurement of physical distress with dacryoendoscopic examination and treatment
Date of disclosure of the study information 2020/06/10
Last modified on 2023/06/13 09:54:57

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Basic information

Public title

Measurement of damage with dacryoendoscopic examination and treatment

Acronym

Damage with dacryoendoscopic examination and treatment

Scientific Title

Measurement of physical distress with dacryoendoscopic examination and treatment

Scientific Title:Acronym

Physical distress with dacryoendoscopic examination and treatment

Region

Japan


Condition

Condition

lacrimation and epiphora

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the physical distress with visual analog score (VAS) in dacryoendoscopic examination and treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

1, Assessment of distress scale of each step in dacryoendoscopic examination
2, 1, Assessment of distress scale of each step in dacryoendoscopic probing and intubation

Key secondary outcomes

1, Comparison of distress scale of dacryoendoscopic examination between pre and post operation
2, Comparison of distress scale of dacryoendoscopic probing and intubation between canalicular and nasolacrimal duct obstruction
3, Development of anesthesia to reduce physical distress


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with lacrimation or epiphora
Patients with lacrimal duct obstruction who were treated with dacryoendoscopic probing and intubation

Key exclusion criteria

a) Patients who do not agree with this survey
b) Patients who are judged to be unsuitable for participation in this study by the investigator

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tomoyuki
Middle name
Last name Kamao

Organization

Ehime University

Division name

Ophthalmology

Zip code

7910295

Address

Shitsukawa, Toon-city, Ehime

TEL

+81-89-960-5361

Email

t-kamao@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name Tomoyuki
Middle name
Last name Kamao

Organization

Ehime University

Division name

Ophthalmology

Zip code

7910295

Address

Shitsukawa, Toon-city, Ehime

TEL

+81-89-960-5361

Homepage URL


Email

t-kamao@m.ehime-u.ac.jp


Sponsor or person

Institute

Ehime University

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

Institutional Review Board,Ehime University Hospital

Address

Shitsukawa, Toon-city, Ehime

Tel

+81-89-960-5172

Email

rinri@m.ehime-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

愛媛大学医学部附属病院(愛媛県) Ehime University Hospital


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://search.jamas.or.jp/link/ui/V525230022

Number of participants that the trial has enrolled

122

Results

Regarding anesthesia, there was no significant difference between the two groups for both ophthalmic and intralacrimal anesthesia preoperatively and postoperatively. On the other hand, the preoperative group scored significantly higher (p=0.0002, <0.0001) than the postoperative group for examination procedures: 37.3 preoperatively for lacrimal dilation and 15.0 postoperatively, and 43.4 preoperatively and 19.3 postoperatively for lacrimal endoscopy.

Results date posted

2023 Year 06 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 05 Month 01 Day

Baseline Characteristics

The subjects were 122 patients (41 males and 81 females, mean age 72.7 years) who underwent lacrimal duct endoscopy by the same examiner preoperatively or postoperatively at the Department of Ophthalmology, Ehime University Hospital from June 2018 to August 2019. Patients selected for the study were men and women aged 20 years or older who consented to the study and who had unilateral or bilateral lacrimal duct obstruction. Those who could not cooperate in answering the questionnaire were excluded.

Participant flow

Anesthesia was performed with oxybuprocaine hydrochloride 0.4% twice and lidocaine hydrochloride (lidocaine) 4% once every 2 minutes for ophthalmic anesthesia, then lidocaine 4% was injected into the tear duct through the upper lacrimal point for surface anesthesia in the tear duct, and lacrimal endoscopy was started within 5 minutes. Lacrimal duct endoscopy was performed under distilled water irrigation using a rigid lacrimal duct endoscope (LAC-06FY-H, Machida Corporation, Tokyo, Japan) with a 0.9 mm diameter curved probe after dilation of the upper and lower lacrimal ducts using a lacrimal point dilating needle (Inami, Tokyo, Japan). Preoperative lacrimal duct endoscopy was performed bilaterally in all patients. On the other hand, postoperative lacrimal duct endoscopy was performed only on the treated side. Postoperative lacrimal duct endoscopy was performed at the time of removal of the lacrimal duct tube or six months after removal of the lacrimal duct tube.

Adverse events

None

Outcome measures

The male/female ratio, age, and VAS of anesthesia, examination maneuvers, and degree of tension were compared in two groups: preoperative and postoperative, unilateral and bilateral, and at the time of removal of the tear duct tube and six months after removal. Correlations between anesthesia, examination procedures, and degree of tension were also examined. Chi-square test was used to compare male/female ratios, student's t-test was used to compare age and VAS, and Pearson's product rate correlation coefficient was calculated for correlations, all at the 5% significance level. JMP 11.2 (SAS institute, North Carolina, USA) was used for statistical analysis.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 08 Month 01 Day

Date of IRB

2017 Year 08 Month 30 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2022 Year 08 Month 31 Day

Date of closure to data entry

2023 Year 06 Month 12 Day

Date trial data considered complete

2023 Year 06 Month 12 Day

Date analysis concluded

2023 Year 06 Month 12 Day


Other

Other related information

Retrospective nonrandomized observational study
Patients who underwent dacryoendoscopic examination before and after treatment
Patients with lacrimal duct obstruction who underwent dacryoendoscopic probing and intubation
To score physical distress, a visual analog scale (VAS) was created. The scale ranged from 0 = no pain to 100 = impatient pain.


Management information

Registered date

2020 Year 06 Month 10 Day

Last modified on

2023 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name