Clinical Trial: A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Comparative Study of Recessive Spherical Headed Silicone Intubation and Dacryocystorhinostomy Under Nasal Endoscopy in the Treatment of Nasolacrimal Duct Obstruction

Brief Summary: To compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.

Detailed Summary: Lacrimal 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. However, with the development of endoscopy, the investigators prefer to the silicone nasolacrimal intubation under nasal endoscopy, which is more simple and efficient. With endoscopy, the investigators can see anatomical structures clearly and then can perform the operation much more perfectly.Compare to the classic one called DCR, its short and long term therapeutic effects are equal and even better.Therefore,the latter type does do good to both doctors and patients.
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Current Primary Outcome:

  • Epiphora Improvement [ Time Frame: one-year follow-up ]
    Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora.
  • Lacrimal Passage Irrigation [ Time Frame: one-year follow-up ]
    Cure:no reflux after lacrimal passage irrigation. Effective:a little reflux after lacrimal passage irrigation. Invalid:a lot reflux after lacrimal passage irrigation.


Original Primary Outcome: Epiphora Improvement [ Time Frame: one year ]

Epiphora is completely improved.


Current Secondary Outcome: Postoperative Visual Analogue Scale (VAS) [ Time Frame: 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. ]

From 0 to 10 according to the patients' feeling and life quality


Original Secondary Outcome: VAS score [ Time Frame: one year ]

from 0 to 10 according to the patients' life quality


Information By: Third Affiliated Hospital, Sun Yat-Sen University

Dates:
Date Received: December 9, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: September 9, 2016
Last Verified: September 2016