A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction

NCT02636257 | Completed Phase 1 DMC

• 1 other identifier: SYSU-5010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lacrimal Duct Obstruction

Keywords

Silicone Nasolacrimal Intubation; Dacryocystorhinostomy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• 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.

Other Outcomes (4)

• 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

Study Arms (2)

Recessive Spherical Headed Silicone Intubation

EXPERIMENTAL

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.

Procedure: Recessive Spherical Headed Silicone Intubation

Dacryocystorhinostomy

OTHER

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.

Procedure: Dacryocystorhinostomy

Interventions

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.

Recessive Spherical Headed Silicone Intubation

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.

Dacryocystorhinostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

ThirdSunYatSen

Guangzhou, Guangdong, 510630, China

Location

Related Publications (4)

• McDonogh M, Meiring JH. Endoscopic transnasal dacryocystorhinostomy. J Laryngol Otol. 1989 Jun;103(6):585-7. doi: 10.1017/s0022215100109405.

  PMID: 2769026 BACKGROUND

• 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.

  PMID: 11603798 BACKGROUND

• Wormald PJ. Powered endoscopic dacryocystorhinostomy. Laryngoscope. 2002 Jan;112(1):69-72. doi: 10.1097/00005537-200201000-00013.

  PMID: 11802041 BACKGROUND

• 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.

  PMID: 23120728 BACKGROUND

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Interventions

Dacryocystorhinostomy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ostomy

Study Officials

• Yang Qintai, director

  Sun Yat Sen Univ, Affiliated Hosp 3, Dept Otorhinolaryngol Head & Neck Surg, Guangzhou 510630, Guangdong, Peoples R China.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 21, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

CN (1)