Lacrimal Stenosis of Both EyesNCT06983717
Lacrimal Deroofing for Epiphora
An observational study of Lacrimal Stenosis of Both Eyes, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Puncto-canalicular abnormalities, such as obstruction and canaliculitis, are a significant cause of epiphora. They involve proximal lacrimal drainage system. Proximal lacrimal obstructions classified into punctal stenosis canalicular obstructions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lacrimal Stenosis of Both Eyes
- What is being tested?
- lacrimal deroofing
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 12 May 2023to 23 Jan 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: at least 18 years old patients
Who may be able to join
- epiphora due to lacrimal punctum stenosis and/or canaliculitis.
Who cannot join
- Trauma, Thyroid eye disease, lacrimation and other causes of epiphora.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lacrimal Deroofing for the Management of Epiphora From Lacrimal Punctal- Canalicular Abnormalities
Puncto-canalicular abnormalities, such as obstruction and canaliculitis, are a significant cause of epiphora. They involve proximal lacrimal drainage system. Proximal lacrimal obstructions classified into punctal stenosis canalicular obstructions. The basic principles in the treatment of punctal stenosis include creating an adequate opening, while maintaining the position of the punctum against the lacrimal lake, and preserving the lacrimal pump function. The severity of epiphora can be valued trough a grading system such as the Munk scale, fluorescein dye disappearance test, and syringing and probing and contrast dacryocystography. Canaliculitis is defined as infection of the proximal part of the lacrimal drainage system. This condition can be caused by primary infectious organisms or secondary to punctal plugs and lacrimal stents. Diagnosing canaliculitis is frequently misdiagnosed. The management includes conservative measures, local massage, syringing, and irrigation. Nevertheless, refractory cases required surgical intervention.
Read the detailed description
Purpose: To report outcomes of proximal lacrimal deroofing in the management of proximal lacrimal drainage system abnormalities. Inclusion criteria: At least 18 years old patients with lacrimal punctum stenosis and/or canaliculitis. Exclusion Criteria: Trauma, Thyroid eye disease, lacrimation and other causes of epiphora. Evaluation: All patients underwent a comprehensive ophthalmic examination, and lacrimal drainage evaluation at baseline,2 weeks and 6 months after the surgery.
Outcome Measures:
Munk scale for epiphora grading (0-5); 0 No epiphora ,1 Epiphora requiring dabbing less than twice a day, 2 Epiphora requiring dabbing 2-4 times a day, 3 Epiphora requiring dabbing 5-10 times a day, 4 Epiphora requiring dabbing more than 10 times a day, 5 Constant epiphora. Grading of External Lacrimal Puncum (0-5); score 0: No papilla and punctum (punctal atresia); surgery to create a papilla, score1: Papilla is covered by a membrane; a #25 needle, followed by a punctal finder. Exudative or true membrane or fibrosis, difficult to recognize with standard punctum dilator, score 2: Less than normal size, but recognizable; a punctal finder and, then a standard punctum dilator required, score 3: Normal; regular punctum dilator required, score 4: Small slit (< 2 mm); no intervention required, score 5 Large slit (≥ 2 mm); no intervention required.
- Conditions
- Lacrimal Stenosis of Both Eyes
- Being tested
- lacrimal deroofing
- Keywords
- lacrimal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lacrimal deroofingProcedure or surgery
After infiltration anesthesia, patient underwent proximal lacrimal deroofing. Proper punctal dilatation is done, followed by combined 1 snip punctoplasty with a lateral canaliculotomy/ Punctotomy and posterior canaliculotomy of the lateral third. En-bloc expulsion of the concretion was done in case of canaliculitis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Munk scale for epiphora grading (0-5)
0 No epiphora ,1 Epiphora requiring dabbing less than twice a day, 2 Epiphora requiring dabbing 2-4 times a day, 3 Epiphora requiring dabbing 5-10 times a day, 4 Epiphora requiring dabbing more than 10 times a day, 5 Constant epiphora.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start12 May 2023
- Primary completion18 Dec 2024
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacrimal Stenosis of Both EyesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983717
- Sponsor's protocol ID
- hamaky23
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: by direct contact through email
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacrimal Deroofing for the Management of Epiphora From Lacrimal Punctal- Canalicular Abnormalities
- ClinicalTrials.gov ID
- NCT06983717
- Acronym / sponsor ID
- hamaky23
- Conditions
- Lacrimal Stenosis of Both Eyes
- Keywords
- lacrimal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 21 May 2025 (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.
Puncto-canalicular abnormalities, such as obstruction and canaliculitis, are a significant cause of epiphora. They involve proximal lacrimal drainage system. Proximal lacrimal obstructions classified into punctal stenosis canalicular obstructions. The basic principles in the treatment of punctal stenosis include creating an adequate opening, while maintaining the position of the punctum against the lacrimal lake, and preserving the lacrimal pump function. The severity of epiphora can be valued trough a grading system such as the Munk scale, fluorescein dye disappearance test, and syringing and probing and contrast dacryocystography. Canaliculitis is defined as infection of the proximal part of the lacrimal drainage system. This condition can be caused by primary infectious organisms or secondary to punctal plugs and lacrimal stents. Diagnosing canaliculitis is frequently misdiagnosed. The management includes conservative measures, local massage, syringing, and irrigation. Nevertheless, refractory cases required surgical intervention.
Detailed description
Purpose: To report outcomes of proximal lacrimal deroofing in the management of proximal lacrimal drainage system abnormalities. Inclusion criteria: At least 18 years old patients with lacrimal punctum stenosis and/or canaliculitis. Exclusion Criteria: Trauma, Thyroid eye disease, lacrimation and other causes of epiphora. Evaluation: All patients underwent a comprehensive ophthalmic examination, and lacrimal drainage evaluation at baseline,2 weeks and 6 months after the surgery.
Outcome Measures:
Munk scale for epiphora grading (0-5); 0 No epiphora ,1 Epiphora requiring dabbing less than twice a day, 2 Epiphora requiring dabbing 2-4 times a day, 3 Epiphora requiring dabbing 5-10 times a day, 4 Epiphora requiring dabbing more than 10 times a day, 5 Constant epiphora. Grading of External Lacrimal Puncum (0-5); score 0: No papilla and punctum (punctal atresia); surgery to create a papilla, score1: Papilla is covered by a membrane; a #25 needle, followed by a punctal finder. Exudative or true membrane or fibrosis, difficult to recognize with standard punctum dilator, score 2: Less than normal size, but recognizable; a punctal finder and, then a standard punctum dilator required, score 3: Normal; regular punctum dilator required, score 4: Small slit (< 2 mm); no intervention required, score 5 Large slit (≥ 2 mm); no intervention required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- at least 18 years old patients
Key inclusion criteria (1 listed)
- epiphora due to lacrimal punctum stenosis and/or canaliculitis.
Key exclusion criteria (1 listed)
- Trauma, Thyroid eye disease, lacrimation and other causes of epiphora.
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 |
|---|---|---|
| lacrimal deroofingAfter infiltration anesthesia, patient underwent proximal lacrimal deroofing. Proper punctal dilatation is done, followed by combined 1 snip punctoplasty with a lateral canaliculotomy/ Punctotomy and posterior canaliculotomy of the lateral third. En-bloc expulsion of the concretion was done in case of canaliculitis. | Procedure or surgery | – |
Primary outcome
Munk scale for epiphora grading (0-5)
Time frame: 6 months
0 No epiphora ,1 Epiphora requiring dabbing less than twice a day, 2 Epiphora requiring dabbing 2-4 times a day, 3 Epiphora requiring dabbing 5-10 times a day, 4 Epiphora requiring dabbing more than 10 times a day, 5 Constant epiphora.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. by direct contact through email
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lacrimal Stenosis of Both Eyes, run by Benha University at 1 site in United Arab Emirates.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 May 2025. 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 United Arab Emirates. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Munk scale for epiphora grading (0-5) (time frame: 6 months). 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 21 May 2025.