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.
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.
Iran1 site, 1 recruiting
- 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
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
- Conditions
- Primary Acquired Nasolacrimal
- 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 group | Role | What they receive |
|---|---|---|
| Endoscopic DCR | Experimental | 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. Receives: Procedure: Endoscopic DCR; Procedure: External DCR |
| External DCR | Active comparator | 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 Receives: Procedure: Endoscopic DCR; Procedure: External DCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
general success rate
anatomic patency of lacrimal drainage+ Functional such (absence of epiphora and discharge )
Measured: 12 months after operation.
Secondary outcomes (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.
- First posted15 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Acquired NasolacrimalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endonasal-Endoscopic Dacryocystorhinostomy Versus External Dacryocystorhinostomy
- ClinicalTrials.gov ID
- NCT02993770
- Acronym / sponsor ID
- IR.TUMS.REC.1394.853
- Conditions
- Primary Acquired Nasolacrimal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic DCR | Experimental | Procedure: Endoscopic DCR, Procedure: External DCREndoscopic 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. |
| External DCR | Active comparator | Procedure: Endoscopic DCR, Procedure: External DCRExternal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,..).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic DCREndonasal endoscopic technique as described by Wormold et al. | Procedure or surgery | Endoscopic DCR, External DCR |
| External DCRExternal DCR | Procedure or surgery | Endoscopic DCR, External DCR |
Primary outcome
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.
anatomic patency of lacrimal drainage
Functional success rate endonasal endoscopic- DCR (En-DCR) with traditional external-DCR (Ext-DCR) in patients with PANDO
Time frame: 12 months after operation.
absence of epiphora and discharge
general success rate
Time frame: 12 months after operation.
anatomic patency of lacrimal drainage+ Functional such (absence of epiphora and discharge )
1 secondary outcome
Complications of operation
Time frame: 12 months after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.