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 |
Measurement of damage with dacryoendoscopic examination and treatment
Damage with dacryoendoscopic examination and treatment
Measurement of physical distress with dacryoendoscopic examination and treatment
Physical distress with dacryoendoscopic examination and treatment
Japan |
lacrimation and epiphora
Ophthalmology |
Others
NO
To determine the physical distress with visual analog score (VAS) in dacryoendoscopic examination and treatment
Safety,Efficacy
Exploratory
Others
Not applicable
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
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
Observational
20 | years-old | <= |
90 | years-old | > |
Male and Female
Patients with lacrimation or epiphora
Patients with lacrimal duct obstruction who were treated with dacryoendoscopic probing and intubation
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
200
1st name | Tomoyuki |
Middle name | |
Last name | Kamao |
Ehime University
Ophthalmology
7910295
Shitsukawa, Toon-city, Ehime
+81-89-960-5361
t-kamao@m.ehime-u.ac.jp
1st name | Tomoyuki |
Middle name | |
Last name | Kamao |
Ehime University
Ophthalmology
7910295
Shitsukawa, Toon-city, Ehime
+81-89-960-5361
t-kamao@m.ehime-u.ac.jp
Ehime University
None
Other
Institutional Review Board,Ehime University Hospital
Shitsukawa, Toon-city, Ehime
+81-89-960-5172
rinri@m.ehime-u.ac.jp
NO
愛媛大学医学部附属病院(愛媛県) Ehime University Hospital
2020 | Year | 06 | Month | 10 | Day |
Published
http://search.jamas.or.jp/link/ui/V525230022
122
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.
2023 | Year | 06 | Month | 13 | Day |
2021 | Year | 05 | Month | 01 | Day |
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.
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.
None
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.
Completed
2017 | Year | 08 | Month | 01 | Day |
2017 | Year | 08 | Month | 30 | Day |
2017 | Year | 09 | Month | 01 | Day |
2022 | Year | 08 | Month | 31 | Day |
2023 | Year | 06 | Month | 12 | Day |
2023 | Year | 06 | Month | 12 | Day |
2023 | Year | 06 | Month | 12 | Day |
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.
2020 | Year | 06 | Month | 10 | Day |
2023 | Year | 06 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046476
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