Endo-nasal Endoscopic DCR and External-DCR in Primary Nasolacrimal Duct Obstruction
NCT ID: NCT02993770
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
120 participants
INTERVENTIONAL
2016-03-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
All operations will be performed under general or local anesthesia, based on patient and surgeon preferences.
Surgical Technique:
All En-DCR surgeries will be performed by a single ophthalmic plastic surgeon expert in endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described by Wormold.
Using a 0 degree 4-mm endonasal endoscope nasal mucoperiosteum in the area of the lacrimal sac will be incised and elevated. Then rhinostomy will be made using forceps, exposing lacrimal sac. Lacrimal sac will be opened and a Crawford silicone tube will be passed through puncta into nasal cavity and stabilized and will be kept for 2 months. After operation patients will receive nasal beclomethasone twice daily for 2 weeks, nasal drop phenylephrine 0.25% four times daily and ophthalmic drop fluorometholone and Levofloxacin four times daily for one week.
External DCR will be performed in a conventional manner \[2\]via a nasal side straight skin incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will be separated using blunt dissection to expose the periosteum overlying and medial to the anterior lacrimal crest. After incision of the periosteum, an osteotomy approximately 10 mm in diameter will be prepared. The lacrimal sac and then nasal mucosa will be opened by an "H" incision to form maximal anterior flaps. A Bodkin tube will be passed through puncta into nasal cavity of stabilized by multiple square knots at the end. The small posterior flaps will be cut and excised and anterior flaps will be sutured together with 2 or 3 6-0 vicryl sutures. The periosteum, orbicularis oculi muscle, will be sutured by 6-0 vicryl sutures. Skin will be sutured by Nylon 6-0 by interrupted style in the standard manner. Nasal packing will not be placed. All Ext-DCR operations will be performed by one of the two expert ophthalmic plastic surgeons (F.P and A.K.).
The amount of bleeding will be estimated and recorded by the subtracting the total suction reservoir from the amount of irrigated fluid through syringe during operation. Time of operation will be estimated and recorded from the time of anesthetics injection to removing the drape.
One week after operation patients will be asked to report post-operative pain and discomfort by visual analogue score scale (0-10).
27 Seven days after operation skin sutures of patients in group 2 will be removed if skin is healed, and complications, if any, will be detected and recorded in the special data sheets. Nasal bleeding, medial canthal swelling and erythema, ocular surface fluorescein staining and any complications will be detected and recorded. Dye disappearance test (DDT) will be checked and recorded. Epiphora will be recorded according to modified Munk epiphora staging scale.
Two months after operation, ocular surface will be checked by fluorescein for staining of cornea and conjunctiva. Then silicone tube will be removed. epiphora will be recorded according to our staging system. Dye disappearance test (DDT) and Fluorescein Dynamic Dye test (FDDT) and irrigation test, epiphora and skin scar by visual analogue scale (VAS) visual analogue scale will be checked in months 2, 6, 12, 18 and after operation. Satisfaction will be checked 2 mo and 18 mo after operation by VAS. Any grade of daily epiphora or return of fluid\>20% through opposite punctum in irrigation test or negative FDDT (absence of fluid passage) will be regarded as functional or anatomic failure, respectively. Any complication will be recorded in the specific forms.
All pre-operative and post-op examinations will be performed by a masked senior ophthalmology resident subjective data will be checked and recorded by a trained nurse
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques
NCT04952454
A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction
NCT02636257
Safety and Efficacy of Thermosensitive Hydroxybutyl Chitosan and 5-fluorouracil Assisted Endoscopic Dacryocystorhinostomy in the Treatment of Chronic Dacryocystitis
NCT06175676
Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy
NCT06530264
Lacrimal Drainage Resistance Study
NCT01766232
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Endoscopic DCR
Endoscopic DCR will be performed by a single ophthalmic plastic surgeon expert in endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described by Wormold.
Endoscopic DCR
Endonasal endoscopic technique as described by Wormold et al.
External DCR
External DCR
External DCR
External DCR will be performed in a conventional mannervia a nasal side straight skin incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will be separated using blunt dissection to expose the periosteum overlying and medial to the anterior lacrimal crest
Endoscopic DCR
Endonasal endoscopic technique as described by Wormold et al.
External DCR
External DCR
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endoscopic DCR
Endonasal endoscopic technique as described by Wormold et al.
External DCR
External DCR
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosis of PANDO (primary acquired nasolacrimal duct obstruction) if each one of the following exist:
1\) Regurgitation of pus/mucous by pressure on lacrimal sac. 2) Return of pus/mucous fluid by irrigation test through one lacrimal punctum. 3) Dacryocystography or lacrimal scintigraphy compatible with nasolacrimal duct obstruction.
3\. Absence of secondary causes of nasolacrimal duct obstruction (NLDO) such as nasal and sinuses diseases, inflammatory and neoplastic lesions involving the lacrimal drainage system, nasolacrimal trauma.
Exclusion Criteria
2. Use of anti-coaggulation medications \[aspirin, NSAIDS (non-steroidal anti-inflammatory drugs), Warfarin\] within 3-10 days before surgery.
3. Handicap/mental retardation.
4. Pregnant women.
5. Patients with Immunodeficient status (AIDS, use of immunosuppressive medications, leukemia, lymphoma,..).
6. Nasal inflammatory disease (rhinitis, allergies).
7. Granulomatous diseases such as Wegeners, Sarcoidosis, etc.
8. History of past lacrimal surgery.
9. Traumatic NLDO.
10. Follow up less than 3 months.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tehran University of Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Farabi Hospital, Tehran University of Medical Sciences
Tehran, , Iran
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IR.TUMS.REC.1394.853
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.