Sponsor study identifier
interventional
50
1 country
1
Study Start
July 2015
Actual (reported)Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)To compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2015
Actual (reported)December 9, 2015
Actual (reported)December 21, 2015
Actual (reported)January 2017
Actual (reported)January 2017
Actual (reported)Epiphora Improvement
Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora.
one-year follow-up
Lacrimal Passage Irrigation
Cure:no reflux after lacrimal passage irrigation. Effective:a little reflux after lacrimal passage irrigation. Invalid:a lot reflux after lacrimal passage irrigation.
one-year follow-up
Postoperative Visual Analogue Scale (VAS)
Six times in one-year follow-up,respectively,immediate post-surgical,the 1th week,the 1th month,the 3rd month,the 6th month and the 12th month after the surgery.
Bleeding volume in milliliter during the surgery
one-year follow-up
Operating time in minutes
one-year follow-up
hospitalization time in hours
one-year follow-up
The silicone nasolacrimal intubation under nasal endoscopy can restore natural drainage pathway in tears and as an out-patient surgery, it is more simple,cheap and mini-invasive.Recessive Spherical Headed Silicone Intubation is safe,convenient and almost unpainful for no trauma.It has no facial scar and no damage for structure and function of lacrimal duct.Besides,silica gel is non-toxic and nonirritating.Nasal endoscopy handed by otorhinolaryngologist helps intraoperative visualization about anatomy of the nasal cavity,understanding and management of congenital nasolacrimal duct obstruction and is the only method that confirms the correct anatomic position of the catheterization and in real time,avoiding traditionally the blind raking-out wire by the ophthalmologist alone.Compare to the classic DCR,its short therapeutic effects are equal but more convenient and fewer time and money-cost.
Nasolacrimal duct obstruction is common among patients with epiphora,which is seriously affect the quality of life. The treatment principle is to restore or rebuild the lacrimal duct drainage channel. The classic operation type is dacryocystorhinostomy(DCR), which is complex for face-section particularly.After surgery the lacrimal passage can't siphon the tear out physically any more so that it will effect the patients' life.Besides,the operating time,bleeding volume,hospitalization time and total cost for the surgery is higher.
Local anesthesia,regular disinfection, spread sterile towels, exposure operative side.2%lidocaine infiltration anesthesia to inferior orbital nerves, lacrimal punctum and lacrimal sac. Nasal cavity was packed with gauze soaked in 2%ephedrine with 1%tetracaine 15 minutes before procedure.A routine silicone tube of spherical intubation was performed. Dilatated lacrimal point to the end, then inserted the probe with line from lacrimal punctum to inferior meatus through nasolacrimal duct.Cut the line and flush the lacrimal duct physiological saline in 5 mL, flowing the line into the inferior meatus, then suctioned out the line with nasal endoscopy and extracted the probe and dilatated the lacrimal duct again. Insert the spherical silicone tube from lacrimal point to the lacrimal sac, reversing to vertical direction to ensure the tube is inserted into the nasolacrimal duct, then catch the above line but cut short the follow one and fix.Unobstructed lacrimal irrigation.
ThirdSunYatSen
Guangzhou, Guangdong, 510630, China
McDonogh M, Meiring JH. Endoscopic transnasal dacryocystorhinostomy. J Laryngol Otol. 1989 Jun;103(6):585-7. doi: 10.1017/s0022215100109405.
Onerci M, Orhan M, Ogretmenoglu O, Irkec M. Long-term results and reasons for failure of intranasal endoscopic dacryocystorhinostomy. Acta Otolaryngol. 2000 Mar;120(2):319-22. doi: 10.1080/000164800750001170.
Wormald PJ. Powered endoscopic dacryocystorhinostomy. Laryngoscope. 2002 Jan;112(1):69-72. doi: 10.1097/00005537-200201000-00013.
Yang Qintai, director
Sun Yat Sen Univ, Affiliated Hosp 3, Dept Otorhinolaryngol Head & Neck Surg, Guangzhou 510630, Guangdong, Peoples R China.
First Submitted
December 9, 2015
First Posted
December 21, 2015
Study Start
July 2015
Actual (reported)Primary Completion
January 2017
Actual (reported)Outcomes of Early Lacrimal Probing Versus Lacrimal Sac Massage in Infants With Congenital Nasolacrimal Duct Obstruction
Surgery was performed under local anesthesia.Incision was taken over anterior lacrimal crest.Medial palpebral ligament was identified.Orbicularis was separated.Reflection of periosteum and dissection of lacrimal sac from lacrimal fossa was done.Sac was excised to make'H'shaped anterior and posterior flaps. Bony osteum of sufficient size was made with bone punch.Nasal mucosa was cut to make anterior and posterior flaps.Subsequently anterior to anterior and posterior to posterior flaps were sutured.
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Saroj G, Rashmi G. Conventional dacryocystorhinostomy versus endonasal dacryocystorhinostomy-a comparative study. Indian J Otolaryngol Head Neck Surg. 2010 Sep;62(3):296-8. doi: 10.1007/s12070-010-0087-4. Epub 2010 Oct 12.
Study Completion
January 2017
Actual (reported)Last Updated
October 11, 2017
Record last verified: 2017-10
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