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Completed

NCT Number: NCT02636257

A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

ThirdSunYatSen

Guangzhou, Guangdong, 510630, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recessive Spherical Headed Silicone Intubation

Procedure

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.

Dacryocystorhinostomy

Procedure

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.

Primary outcomes

  1. Epiphora Improvement

    Time frame: one-year follow-up

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

  2. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. Bleeding volume in milliliter during the surgery

    Time frame: one-year follow-up

    The surgeon records the cadaverine quantity of bleeding

  2. Operating time in minutes

    Time frame: one-year follow-up

    Recessive Spherical Headed Silicone Intubation Under Nasal Endoscopy was from dilatation to unobstructed lacrimal irrigation.Dacryocystorhinostomy was from flap incision to packing.

  3. hospitalization time in hours

    Time frame: one-year follow-up

    From admission formalities to leave hospital

  4. total cost on the treatment in yuan

    Time frame: one-year follow-up

    From admission formalities to leave hospital

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Acronym: ACSOTEOFLDO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2015
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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