lacrimal duct obstruction
Conditions
Interventions
control group:Y-shaped Lacrimal duct expansion drainage tube
experimental group:novel dilatable lacrimal scaffold
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 40-70 years old male or female; (2) Have symptoms and/or signs of lacrimal duct obstruction, as epiphora or conjunctival sac secretions, positive results (2 or 3 degree) of FDDT test in unilateral lacrimal duct or bilateral lacrimal ducts, obstruction of unilateral lacrimal duct or bilateral lacrimal ducts when irrigating lacrimal ducts. The diagnose of unilateral lacrimal duct or bilateral lacrimal ducts obstruction is clearly through radiography of lacrimal duct with CT; (3) Patients who had once suffered probing of lacrimal passage but still have symptoms and signs of lacrimal duct obstruction and the obstruction of lacrimal duct irrigation; (4) No mental and severe systemic illness, follow-up on time, use Levofloxacin as the only Eye Drop before and after Lacrimal duct catheterization; (5) Understanding the purpose of the test, participating voluntarily and signing the informed consent form by the patient or his/her legal guardian.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of acute or chronic dacryocystitis, have sticky or purulent discharge when irrigating lacrimal ducts; (2) Patients with a history of nasal trauma or surgery, preoperative CT dacryocystography showed bony nasolacrimal duct obstruction or preoperative nasal endoscopy revealed inferior nasal meatus disease; (3) Special cases, such as patients with congenital nasolacrimal duct obstruction, extensive organization and adhesion leading to the blockage of the lacrimal canaliculi which can not be probed, and lacrimal punctum occlusion; (4) Patients who can not bear Lacrimal duct probing under surface anesthesia; (5) Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, mental disorders, and diabetes mellitus; (6) Pregnant or lactating women, patients who participate in other drug or medical device clinical trials within 30 days prior to screening, and other cases in which researchers determine that patients are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patency rate of lacrimal duct irrigation 4 months after lacrimal duct extubation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The patency rate of lacrimal duct irrigation 1week and 1 month after lacrimal duct extubation;The time required to flush lacrimal ducts with 5 ml of saline under constant pressure (unit: seconds) (before sugery, 1week and 1month after lacrimal duct extubation, and 4months after lacrimal duct extubation or the final visit);CT lacrimal duct radiography, to assess the postoperative patency rate and to measure typical lacrimal parameters of different layers(within 1 week before sugery, 4months after lacrimal duct extubation or the final visit);The degree of epiphora (before sugery, 1week and 1month after lacrimal duct extubation, and 4months after lacrimal duct extubation or the final visit); | — |
Countries
China
Contacts
Public ContactBi Yanlong
Outcome results
None listed