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KMID : 9000120180010200001
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NECA Report
2018 Volume.1 No. 20 p.1 ~ p.76
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Dacryoendoscopy
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Shin Chae-Min
Lee Min-Jin
Shin Hae-Won
Jeon Mi-Hye
Ko Ryeo-Jin
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Abstract
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Applied Technology:
Dacryoendoscopy
Dacryoendoscopy is a technique for patients with or suspected of lacrimal duct disorder, where the cause of lesion and the degree and location of obstruction are identified by direct observation of the inside of the lacrimal duct using dacryoendoscopy. The technique was applied as “Diagnosis of Pathology of Lacrimal Drainage System by Lacrimal Endoscopy on Epiphora” on June 28th 2017 based on Article 53 of Medical Service Act and Article 3 of the rules regarding New Health Technology Assessment. The subcommittee later changed the title to “Dacryoendoscopy” to reflect
the use of dacryoendoscopy in identifying the cause of lesion and the degree and location of obstruction.
Management of New Health Technology Assessment Committee and Subcommittee
The 8th New Health Technology Assessment Committee in 2017 (August 25th, 2017) concluded that the applied technique is a new technology that requires assessment for safety and effectiveness. The assessment involved a systematic review of relevant literature by a subcommittee of seven members: four from ophthalmology, two from evidence-based medicine, and one from medical engineering.
The subcommittee assessed the technique Dacryoendoscopy based on the selected evidence found upon the three meetings held between November 14th 2017 and January 29th 2018. The subcommittee reported the results of the assessment, and the 2nd New Health Technology Assessment Committee in 2018 (February 23rd, 2018) provided the final deliberation on the safety and effectiveness of the technique.
Assessment of Dacryoendoscopy
Purpose:
Dacryoendoscopy is a technique for patients with or suspected of lacrimal duct disorder, where the cause of lesion and the degree and location of obstruction are identified by direct observation of the inside of the lacrimal duct using dacryoendoscopy. The purpose of the present assessment is to verify the safety and effectiveness of the technique.
Methods:
The subcommittee on Dacryoendoscopy assessed the safety and effectiveness of the technique by reviewing the articles on patients with or suspected of lacrimal duct disorder. The literature search for Dacryoendoscopy was carried out using eight national databases including KoreaMed and the international databases including Ovid-MEDLINE, Ovid-EMBASE, and Cochrane Library. Using strategic search, 209 articles (208 from international databases; 1 from national databases) were collected. After having excluded 84 duplicated articles, the remaining 125 articles were screened using the inclusion-exclusion criteria, leaving 7 articles (6 from international databases; 1 from national databases) for the final assessment.
The subcommittee and two reviewers independently performed each step of assessment including literature search, inclusion criteria application, and data extraction. The article quality was evaluated using the Scottish Intercollegiate Guidelines Network, and based on the evaluated quality, the level of evidence and grade of recommendation were carefully determined and documented.
Results:
To assess Dacryoendoscopy, seven articles were selected (two diagnostic evaluation studies and five case series; one diagnostic evaluation study was performed in Korea). The selected articles focused on patients suspected of lacrimal duct disorder such as epiphora patients, and those undergoing follow-up monitoring after the surgery. The article quality evaluation score was 2‘+’ for two articles.
Safety
The safety of Dacryoendoscopy was assessed for test-related complications in three articles (case series), and such complications as perforation, hemorrhage, or inflammation were reported not to have occurred. The subcommittee stated that the technique is safe, since test-related complications were not reported in relevant literature, and since the probability of perforation, hemorrhage, or inflammation is expected to be low considering that the technique involves visual inspection of the lesion clinically.
Effectiveness
The effectiveness of Dacryoendoscopy was assessed for the discovery of additional lesions and the effects on the medical outcome as the main parameters, based on the review of five articles (two diagnostic evaluation studies; three case series). For the discovery of additional lesions, the cases reporting the identification of the cause of lesion and the cases reporting the identification of the degree and location of obstruction were separately analyzed. For the effects on the medical outcome, the cases reporting the change in therapy compared to a conventional test and the cases reporting the
determination of therapy through the test were separately analyzed. Discovery of additional lesions was reported in four articles. In one article on identifying the cause of lesion, the test in all 16 patients with lacrimal duct disorder (18 eyes) identified the cause of lesion as mucosal bleeding in lacrimal duct or fibrosis and scar. Identification of the degree and location of obstruction was reported in three articles. In one article, the results of complete obstruction by dacryocystography and lacrimal syringing test (8.3 % (1/12) and 15.4 % (2/13), respectively) were changed to partial obstruction following the test. In another article, the test discovered additional dacryocystostenosis in 16.1 % (5/31) patients diagnosed with lacrimal or nasolacrimal canal obstruction. In the other article, the test discovered granulation tissues in the lacrimal canal in 4.7 % (4/85) patients who received silicon tube intubation. Effects on the medical outcome was reported in three articles. In one article reporting on the change in therapy compared to a conventional test, the change from complete obstruction by dacryocystography to partial obstruction following the test in 8.3 % (1/12) patients led to the change in therapy from dacryocystorhynostomy to silicon tube intubation. In two articles (one for 18 eyes;
one for 20 eyes) reporting on the determination of therapy through the test that identified the specific lesion, the therapies determined according to the characteristics of the lesion identified by the test included dacryocystorhynostomy, probe method, silicon catheter insertion, and dacryoendoscopy.
The subcommittee stated that the technique was clinically effective as it aided in the determination of a more appropriate therapy by identifying the cause of lesion that could not be identified by the conventional technique and by precisely identifying the degree and location of obstruction.
Conclusion and Recommendation
Based on the evidence from current literature, the subcommittee concluded as below: Dacryoendoscopy is a safe and effective technique for identifying the cause of lesion and the degree and location of obstruction in patients with or suspected of lacrimal duct disorder (Level of Evidence D). Based on Article 3 Section 6 of the rules regarding New Health Technology Assessment, and based on the report from the subcommittee, the New Health Technology Assessment Committee provided the final deliberation on the applied technique as below (February 23rd, 2018): Dacryoendoscopy is a safe and effective technique for identifying the cause of lesion and the degree and location of obstruction in patients with or suspected of lacrimal duct disorder (Level of Evidence D). The result of deliberation from New Health Technology Assessment Committee and the report from subcommittee were submitted to Minister of Health and Welfare on March 13th 2018, which was revised as Notification 2018-71 of Ministry of Health and Welfare (April 2nd, 2018).
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KEYWORD
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Epiphora, Dacryoendoscopy , Lacrimal endoscopy, Safety, Effectiveness
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