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Primary Acquired NasolacrimalNCT02993770

Endo-nasal Endoscopic DCR and External-DCR in Primary Nasolacrimal Duct Obstruction

A study testing Endoscopic DCR and External DCR in people with Primary Acquired Nasolacrimal, run by Tehran University of Medical Sciences at 1 site in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

All patients with epiphora or eye discharge that admitted to our ophthalmic plastic clinic in Farabi hospital will be systemically evaluated. Those with confirmed diagnosis of primary nasolacrimal duct obstruction (PANDO) that need DCR by one senior ophthalmic plastic consultant, will be randomly assigned to one of… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Primary Acquired Nasolacrimal
What is being tested?
Endoscopic DCR and External DCR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteIran
Study dates
Mar 2016to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age>18 year.
  • 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.

Who cannot join

  • Punctal/Canalicular obstruction.
  • Use of anti-coaggulation medications [aspirin, NSAIDS (non-steroidal anti-inflammatory drugs), Warfarin] within 3-10 days before surgery.
  • Handicap/mental retardation.
  • Pregnant women.
  • Patients with Immunodeficient status (AIDS, use of immunosuppressive medications, leukemia, lymphoma,..).
  • Nasal inflammatory disease (rhinitis, allergies).
Show all 10Show fewer
  • Granulomatous diseases such as Wegeners, Sarcoidosis, etc.
  • History of past lacrimal surgery.
  • Traumatic NLDO.
  • Follow up less than 3 months.

Trial locations and contacts

1 site in 1 country.

Farzad Pakdel, M.D. contact

00989123701876

fapakdel@gmail.com

Iran1 site, 1 recruiting
  • Farabi Hospital, Tehran University of Medical Sciences

    Tehran, 1336616351

    Farzad Pakdel, MD, 00989123701876, fapakdel@gmail.com

    Elham Ashrafi, PhD, 0098 09123257338, ashrafi_eli61@yahoo.com

    Recruiting

Other trials in Iran

About this study

Official title: Comparison of Endonasal-Endoscopic Dacryocystorhinostomy Versus External Dacryocystorhinostomy

All patients with epiphora or eye discharge that admitted to our ophthalmic plastic clinic in Farabi hospital will be systemically evaluated. Those with confirmed diagnosis of primary nasolacrimal duct obstruction (PANDO) that need DCR by one senior ophthalmic plastic consultant, will be randomly assigned to one of the 2 treatment groups: Group 1 External DCR and group 2 En-DCR. Diagnosis of PANDO will be based on the presence of positive regurgitation test or irrigation test or dacryocystography (DCG) . All patients will undergo comprehensive ophthalmology examinations including best corrected visual acuity (BCVA), relative afferent pupillary defect (RAPD), slit lamp anterior segment evaluation, dilated fundoscopy with 78 D lens. Past history and review os systems will be elicited for medications, past or intercurrent dacryocystitis,trauma,past ocular and sinus surgeries, epiphora, discharge, ocular diseases, sinus/nasal diseases, diabetes mellitus, organ transplant, immunosuppressive drugs and immunodeficiency disorders.

All operations will be performed under general or local anesthesia, based on patient and surgeon preferences.

Read more

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

Being tested
Endoscopic DCR, External DCR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic DCRProcedure or surgery

    Endonasal endoscopic technique as described by Wormold et al.

  • External DCRProcedure or surgery

    External DCR

Study groups in NCT02993770
Study groupRoleWhat they receive
Endoscopic DCRExperimentalEndoscopic 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.
Receives: Procedure: Endoscopic DCR; Procedure: External DCR
External DCRActive comparatorExternal 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
Receives: Procedure: Endoscopic DCR; Procedure: External DCR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anatomic success rate of endonasal endoscopic- DCR (En-DCR) with traditional external-DCR (Ext-DCR) in patients with PANDO

    anatomic patency of lacrimal drainage

    Measured: 12 months after operation.

  2. Functional success rate endonasal endoscopic- DCR (En-DCR) with traditional external-DCR (Ext-DCR) in patients with PANDO

    absence of epiphora and discharge

    Measured: 12 months after operation.

  3. general success rate

    anatomic patency of lacrimal drainage+ Functional such (absence of epiphora and discharge )

    Measured: 12 months after operation.

Secondary outcomes (1)
  1. Complications of operation

    Measured: 12 months after operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02993770
Sponsor's protocol ID
IR.TUMS.REC.1394.853
Status last verified
Sep 2019
First submitted
10 Sep 2016
Last updated
5 Feb 2020
Results posted
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic DCR and External DCR in people with Primary Acquired Nasolacrimal, run by Tehran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Farzad Pakdel, M.D. (00989123701876, fapakdel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anatomic success rate of endonasal endoscopic- DCR (En-DCR) with traditional external-DCR (Ext-DCR) in patients with PANDO (time frame: 12 months after operation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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