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A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction

Phase 1
Completed
Conditions
Lacrimal Duct Obstruction
Registration Number
NCT02636257
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Clinical diagnosis of Nasolacrimal Duct Obstruction based on a clinical of epiphora and purulent secretion, another punctiform orifices with reflux in subsequent flushing in lacrimal passage irrigation;
  • Must be able to withstand surgery
  • At least 18 years old
  • NO lacrimal tumor and acute inflammation
  • Nasolacrimal duct obstruction in digital subtraction dacryocystography
  • A sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up;
  • Accepted informed consent verbally and in writing
Exclusion Criteria
  • The Poor Health
  • Be allergic to anesthetics
  • Lacrimal duct abnormalities
  • Lacrimal tumor and acute inflammation
  • Children
  • The same Surgery failure before

Exit Criteria

  • Postoperative infection and persistent inflammation
  • Operation failure.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Epiphora Improvementone-year follow-up

Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora.

Lacrimal Passage Irrigationone-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.

Secondary Outcome Measures
NameTimeMethod
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.

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

Trial Locations

Locations (1)

ThirdSunYatSen

🇨🇳

Guangzhou, Guangdong, China

ThirdSunYatSen
🇨🇳Guangzhou, Guangdong, China

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