Nasolacrimal Duct ObstructionNCT07848932
Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
A study testing Stentless Endoscopic Dacryocystorhinostomy in people with Nasolacrimal Duct Obstruction and Epiphora, run by Assiut University.
Trial summary
This prospective, single-arm interventional clinical study aims to evaluate the short- and intermediate-term anatomical, functional, and quality-of-life outcomes of primary stentless endoscopic dacryocystorhinostomy (En-DCR) in adult patients with primary acquired nasolacrimal duct obstruction (PANDO). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nasolacrimal Duct Obstruction, Epiphora
- What is being tested?
- Stentless Endoscopic Dacryocystorhinostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 years or older
- Symptoms compatible with lacrimal drainage obstruction, particularly persistent epiphora, for at least 3 months
- Objective evidence of primary acquired nasolacrimal duct obstruction (PANDO) by lacrimal irrigation/probing and/or an accepted lacrimal functional test
- Indication for primary dacryocystorhinostomy (DCR) after clinical assessment
- Ability to provide informed consent
- Ability and willingness to attend the scheduled postoperative visits
Who cannot join
- Previous ipsilateral DCR or other lacrimal drainage surgery
- Canalicular or punctal stenosis that independently prevents adequate lacrimal drainage
- Congenital nasolacrimal duct obstruction
- Traumatic, iatrogenic, neoplastic, granulomatous, or other secondary nasolacrimal duct obstruction
- Active uncontrolled acute dacryocystitis at the time of surgery
- Known lacrimal sac or nasal malignancy
Show all 10Show fewer
- Previous major sinonasal surgery likely to substantially alter the lacrimal anatomy
- Severe uncontrolled sinonasal inflammatory disease requiring treatment before DCR
- Severe bleeding disorder or contraindication to surgery
- Inability to comply with postoperative assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction
This prospective, single-arm interventional clinical study aims to evaluate the short- and intermediate-term anatomical, functional, and quality-of-life outcomes of primary stentless endoscopic dacryocystorhinostomy (En-DCR) in adult patients with primary acquired nasolacrimal duct obstruction (PANDO). Endoscopic DCR bypasses the obstructed distal lacrimal drainage pathway by creating a permanent communication between the lacrimal sac and the nasal cavity. While silicone intubation is traditionally used to prevent early restenosis, its routine use remains controversial due to potential foreign-body morbidity, including canalicular trauma, granuloma formation, tube displacement, and the necessity for a secondary removal procedure. The rationale for this study is based on the concept that surgical success is determined by adequate osteotomy, wide sac marsupialization, mucosal flap preservation, and structured postoperative care, rather than the presence of a permanent foreign body. The study will recruit approximately 40 eligible adults (aged $\ge$16 years) with objectively confirmed, symptomatic PANDO to undergo a standardized stentless En-DCR procedure. Participants will undergo rigorous postoperative clinical and endoscopic assessments at 1 week, 1 month, 3 months, 6 months, and 12 months. The primary endpoint is the overall composite success rate at 12 months, defined by both objective anatomical patency of the rhinostomy (verified via endoscopy and lacrimal irrigation) and clinically meaningful functional resolution of epiphora (Munk score 0-1). Secondary objectives include quantifying changes in disease-specific quality of life using the Lac-Q questionnaire, documenting postoperative endoscopic healing parameters, and evaluating the incidence and mechanisms of surgical failure or complications.
Read the detailed description
Primary acquired nasolacrimal duct obstruction (PANDO) is a common cause of persistent epiphora and recurrent lacrimal sac inflammation in adults, resulting from chronic inflammatory remodeling, fibrosis, and progressive narrowing of the distal lacrimal drainage system. Beyond physical discomfort, this condition can substantially interfere with daily activities such as reading, driving, outdoor activities, and social interaction. Endoscopic dacryocystorhinostomy (En-DCR) is a surgical treatment that bypasses the obstructed drainage pathway by creating a permanent communication directly between the lacrimal sac and the nasal cavity. Compared to traditional external approaches, En-DCR avoids a cutaneous incision, preserves the medial canthal anatomy, and allows for direct visualization and simultaneous management of relevant intranasal pathology. Historically, many surgeons have routinely placed silicone stents through the newly created rhinostomy to maintain patency and prevent soft-tissue stenosis during the healing phase. However, the routine use of silicone intubation in primary, uncomplicated cases remains a subject of ongoing clinical debate. Because stents act as foreign bodies, they carry inherent risks, including local mucosal irritation, tube displacement, punctal or canalicular trauma, granuloma formation, and corneal abrasion. Furthermore, stenting increases procedural costs and necessitates a dedicated follow-up visit for tube removal. This study operates on the rationale that the essential determinants of a successful En-DCR are the creation of an adequate bypass and favorable wound healing, rather than the temporary presence of a foreign body. Modern endoscopic techniques enable precise bony osteotomies, complete sac exposure, and meticulous mucosal flap preservation. By prioritizing the wide marsupialization of the lacrimal sac and implementing structured postoperative endoscopic care, the need for routine silicone intubation may be effectively eliminated for carefully selected patients. Participants enrolled in this study will undergo a standardized, stentless En-DCR. The surgical protocol emphasizes exposing the lacrimal bone and frontal process of the maxilla, creating a broad and dependent bony osteotomy, opening the lacrimal sac longitudinally, and preserving mucosal flaps for precise apposition without the insertion of bicanalicular or monocanalicular stents. Standardized postoperative management will involve targeted topical nasal saline irrigations and structured clinical visits for endoscopic cleaning, debridement, and the office-based management of any granulation tissue or synechiae as clinically indicated. By systematically documenting both subjective symptom resolution and objective endoscopic healing, this study seeks to provide robust clinical evidence detailing the healing patterns, failure mechanisms, and overall durability of stentless En-DCR.
- Conditions
- Nasolacrimal Duct Obstruction, Epiphora
- Being tested
- Stentless Endoscopic Dacryocystorhinostomy
- Medical subject headings
- Lacrimal Duct Obstruction, Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stentless Endoscopic DacryocystorhinostomyProcedure or surgery
The intervention consists of a primary endoscopic dacryocystorhinostomy (En-DCR) performed without the routine insertion of a silicone bicanalicular or monocanalicular stent. The standardized surgical technique involves endoscopic localization of the lacrimal sac, creation of a mucosal flap, and a wide bony osteotomy to expose the lacrimal bone and frontal process of the maxilla. The lacrimal sac is opened longitudinally and widely marsupialized into the nasal cavity, prioritizing mucosal flap preservation and precise apposition without placing a tube. This technique relies on adequate osteotomy, sac marsupialization, mucosal healing, and structured postoperative endoscopic care rather than a permanent foreign body to maintain a functional rhinostomy.
| Study group | Role | What they receive |
|---|---|---|
| Stentless Endoscopic Dacryocystorhinostomy (En-DCR) | Experimental | Participants in this arm will undergo a primary endoscopic dacryocystorhinostomy (En-DCR) without the routine insertion of a silicone bicanalicular or monocanalicular stent. The standardized surgical procedure includes the creation of a mucosal flap, a sufficiently wide bony osteotomy, longitudinal opening of the lacrimal sac, and wide marsupialization of the sac mucosa into the nasal cavity. Receives: Procedure: Stentless Endoscopic Dacryocystorhinostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Overall Clinical Success
Overall success is a composite endpoint defined by achieving both functional improvement and anatomical patency. Functional success requires clinically meaningful resolution or marked improvement of epiphora, indicated by achieving a Munk score of 0 or 1. Anatomical success requires objective patency of the surgically created rhinostomy, demonstrated by nasal endoscopy and successful lacrimal irrigation without evidence of clinically significant restenosis. A patient must meet both criteria to be considered an overall success, avoiding overestimation based on anatomy alone.
Measured: 12 months postoperative
Secondary outcomes (3)
Number of Participants Achieving Anatomical Success
Anatomical success is defined as a patent rhinostomy on endoscopic examination with free or satisfactory lacrimal irrigation and no clinically significant obstructing granulation, fibrosis, or synechiae.
Measured: 1 week, 1 month, 3 months, 6 months, and 12 months postoperative
Number of Participants Achieving Functional Success
Functional success is defined by the substantial improvement or resolution of epiphora, indicated by achieving a Munk Epiphora Score of 0 or 1. The Munk Epiphora Score is a grading scale used to quantify tearing severity. The scale ranges from 0 to 4, where 0 indicates no epiphora and 4 indicates constant, severe epiphora requiring wiping 10 or more times a day. Higher scores indicate worse outcomes (more severe tearing).
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months postoperative
Mean Lacrimal Symptom Questionnaire (Lac-Q) Score
Assessment of the social impact and disease-specific quality of life using the Lacrimal Symptom Questionnaire (Lac-Q) to evaluate patient-reported outcomes and symptom improvement. The Lac-Q score ranges from 0 to 14 [(Note: adjust these min/max numbers if your specific modified version of the Lac-Q differs)], where higher scores indicate a worse outcome (greater negative impact on quality of life and more severe symptoms).
Measured: Baseline, 3 months, and 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm clinical study designed to evaluate the outcomes of a primary stentless endoscopic dacryocystorhinostomy (En-DCR) without a comparator group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hassan Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848932
- Sponsor's protocol ID
- Stentless DCR
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction
- ClinicalTrials.gov ID
- NCT07848932
- Acronym / sponsor ID
- Stentless DCR
- Conditions
- Nasolacrimal Duct Obstruction, Epiphora
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- 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.
This prospective, single-arm interventional clinical study aims to evaluate the short- and intermediate-term anatomical, functional, and quality-of-life outcomes of primary stentless endoscopic dacryocystorhinostomy (En-DCR) in adult patients with primary acquired nasolacrimal duct obstruction (PANDO). Endoscopic DCR bypasses the obstructed distal lacrimal drainage pathway by creating a permanent communication between the lacrimal sac and the nasal cavity. While silicone intubation is traditionally used to prevent early restenosis, its routine use remains controversial due to potential foreign-body morbidity, including canalicular trauma, granuloma formation, tube displacement, and the necessity for a secondary removal procedure. The rationale for this study is based on the concept that surgical success is determined by adequate osteotomy, wide sac marsupialization, mucosal flap preservation, and structured postoperative care, rather than the presence of a permanent foreign body. The study will recruit approximately 40 eligible adults (aged $\ge$16 years) with objectively confirmed, symptomatic PANDO to undergo a standardized stentless En-DCR procedure. Participants will undergo rigorous postoperative clinical and endoscopic assessments at 1 week, 1 month, 3 months, 6 months, and 12 months. The primary endpoint is the overall composite success rate at 12 months, defined by both objective anatomical patency of the rhinostomy (verified via endoscopy and lacrimal irrigation) and clinically meaningful functional resolution of epiphora (Munk score 0-1). Secondary objectives include quantifying changes in disease-specific quality of life using the Lac-Q questionnaire, documenting postoperative endoscopic healing parameters, and evaluating the incidence and mechanisms of surgical failure or complications.
Detailed description
Primary acquired nasolacrimal duct obstruction (PANDO) is a common cause of persistent epiphora and recurrent lacrimal sac inflammation in adults, resulting from chronic inflammatory remodeling, fibrosis, and progressive narrowing of the distal lacrimal drainage system. Beyond physical discomfort, this condition can substantially interfere with daily activities such as reading, driving, outdoor activities, and social interaction. Endoscopic dacryocystorhinostomy (En-DCR) is a surgical treatment that bypasses the obstructed drainage pathway by creating a permanent communication directly between the lacrimal sac and the nasal cavity. Compared to traditional external approaches, En-DCR avoids a cutaneous incision, preserves the medial canthal anatomy, and allows for direct visualization and simultaneous management of relevant intranasal pathology. Historically, many surgeons have routinely placed silicone stents through the newly created rhinostomy to maintain patency and prevent soft-tissue stenosis during the healing phase. However, the routine use of silicone intubation in primary, uncomplicated cases remains a subject of ongoing clinical debate. Because stents act as foreign bodies, they carry inherent risks, including local mucosal irritation, tube displacement, punctal or canalicular trauma, granuloma formation, and corneal abrasion. Furthermore, stenting increases procedural costs and necessitates a dedicated follow-up visit for tube removal. This study operates on the rationale that the essential determinants of a successful En-DCR are the creation of an adequate bypass and favorable wound healing, rather than the temporary presence of a foreign body. Modern endoscopic techniques enable precise bony osteotomies, complete sac exposure, and meticulous mucosal flap preservation. By prioritizing the wide marsupialization of the lacrimal sac and implementing structured postoperative endoscopic care, the need for routine silicone intubation may be effectively eliminated for carefully selected patients. Participants enrolled in this study will undergo a standardized, stentless En-DCR. The surgical protocol emphasizes exposing the lacrimal bone and frontal process of the maxilla, creating a broad and dependent bony osteotomy, opening the lacrimal sac longitudinally, and preserving mucosal flaps for precise apposition without the insertion of bicanalicular or monocanalicular stents. Standardized postoperative management will involve targeted topical nasal saline irrigations and structured clinical visits for endoscopic cleaning, debridement, and the office-based management of any granulation tissue or synechiae as clinically indicated. By systematically documenting both subjective symptom resolution and objective endoscopic healing, this study seeks to provide robust clinical evidence detailing the healing patterns, failure mechanisms, and overall durability of stentless En-DCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm clinical study designed to evaluate the outcomes of a primary stentless endoscopic dacryocystorhinostomy (En-DCR) without a comparator group.
| Arm | Type | Receives |
|---|---|---|
| Stentless Endoscopic Dacryocystorhinostomy (En-DCR) | Experimental | Procedure: Stentless Endoscopic DacryocystorhinostomyParticipants in this arm will undergo a primary endoscopic dacryocystorhinostomy (En-DCR) without the routine insertion of a silicone bicanalicular or monocanalicular stent. The standardized surgical procedure includes the creation of a mucosal flap, a sufficiently wide bony osteotomy, longitudinal opening of the lacrimal sac, and wide marsupialization of the sac mucosa into the nasal cavity. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 16 years or older
- Symptoms compatible with lacrimal drainage obstruction, particularly persistent epiphora, for at least 3 months
- Objective evidence of primary acquired nasolacrimal duct obstruction (PANDO) by lacrimal irrigation/probing and/or an accepted lacrimal functional test
- Indication for primary dacryocystorhinostomy (DCR) after clinical assessment
- Ability to provide informed consent
Key exclusion criteria (10 listed)
- Previous ipsilateral DCR or other lacrimal drainage surgery
- Canalicular or punctal stenosis that independently prevents adequate lacrimal drainage
- Congenital nasolacrimal duct obstruction
- Traumatic, iatrogenic, neoplastic, granulomatous, or other secondary nasolacrimal duct obstruction
- Active uncontrolled acute dacryocystitis at the time of surgery
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 |
|---|---|---|
| Stentless Endoscopic DacryocystorhinostomyThe intervention consists of a primary endoscopic dacryocystorhinostomy (En-DCR) performed without the routine insertion of a silicone bicanalicular or monocanalicular stent. The standardized surgical technique involves endoscopic localization of the lacrimal sac, creation of a mucosal flap, and a wide bony osteotomy to expose the lacrimal bone and frontal process of the maxilla. The lacrimal sac is opened longitudinally and widely marsupialized into the nasal cavity, prioritizing mucosal flap preservation and precise apposition without placing a tube. This technique relies on adequate osteotomy, sac marsupialization, mucosal healing, and structured postoperative endoscopic care rather than a permanent foreign body to maintain a functional rhinostomy. | Procedure or surgery | Stentless Endoscopic Dacryocystorhinostomy (En-DCR) |
Primary outcome
Percentage of Participants Achieving Overall Clinical Success
Time frame: 12 months postoperative
Overall success is a composite endpoint defined by achieving both functional improvement and anatomical patency. Functional success requires clinically meaningful resolution or marked improvement of epiphora, indicated by achieving a Munk score of 0 or 1. Anatomical success requires objective patency of the surgically created rhinostomy, demonstrated by nasal endoscopy and successful lacrimal irrigation without evidence of clinically significant restenosis. A patient must meet both criteria to be considered an overall success, avoiding overestimation based on anatomy alone.
3 secondary outcomes
Number of Participants Achieving Anatomical Success
Time frame: 1 week, 1 month, 3 months, 6 months, and 12 months postoperative
Number of Participants Achieving Functional Success
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months postoperative
Mean Lacrimal Symptom Questionnaire (Lac-Q) Score
Time frame: Baseline, 3 months, and 12 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Stentless Endoscopic Dacryocystorhinostomy in people with Nasolacrimal Duct Obstruction and Epiphora, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Hasan Ali, master degree (201062805374, mahmoud.nwawa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Overall Clinical Success (time frame: 12 months postoperative). 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 30 Sep 2026.