Punctal StenosisNCT03498144
Diagnosis of Acquired Punctal Stenosis Using Anterior Segment Optical Coherence Tomography
An observational study of Punctal Stenosis, run by Minia University.
Trial summary
Purpose of the study To evaluate the lower puntum dimensions in cases of acquired punctal stenosis(APS), using anterior segment optical coherence tomography (AS-OCT). Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Punctal Stenosis
- What is being tested?
- Anterior segment OCT
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 Jul 2018
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults with acquired punctal stenosis
Who may be able to join
- Patients with acquired punctal stenosis
Who cannot join
- Punctal agenesis
- Congenital punctal stenosis
- Allergic occlusion
- Lid malposition
- Canalicular, nasolacrimal, sac and duct obstruction
- Previous eyelid or lacrimal drainage surgery
- Untreated conjunctivitis, blepharitis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Acquired Punctal Stenosis by Using Anterior Segment Optical Coherence Tomography (AS-OCT)
Purpose of the study
To evaluate the lower puntum dimensions in cases of acquired punctal stenosis(APS), using anterior segment optical coherence tomography (AS-OCT).
Read the detailed description
(B)Examination:
- External examination: should be done to rule out causes of watering other than punctal stenosis (facial palsy, lacrimal pump failure, swelling in lacrimal sac area and regurge test)
- Slit lamp examination: for tear meniscus, lid margin, conjunctiva and punctual orifice
- Fluorescein dye disappearance test: performed with a drop of 2% fluorescein in lower conjunctival sac, patient is instructed not to wipe the eyes. After 5 minutes, presence of staining in the tear film is assessed with cobalt blue filter.
- Probing and lacrimal syringing, if patent confirms punctal stenosis to be the cause of epiphora rather than block in the lower lacrimal drainage system.
- Anterior segment optical coherence tomography examination (AS-OCT) for the lower punctum: measuring the outer puntcal diametre, inner punctal diameter and punctal depth.
Examination of the lower punctum was performed using Spectral Domain OCT machine; RTVue model-RT100 CAM system (Optovue Inc., Fremont, CA, USA) version 6.2, by attaching the cornea/anterior module lens (CAM). CAM lens has a wide-angle, high-magnification lens of 10 mm working distance. The axial resolution was 5 μm, and the lateral resolution was 8 μm. The scan beam has wavelength of 840 ± 10 nm. The two red external illumination (light emitting diode ) LED on headrest were approximated on each side of the lower punctum for proper illumination and imaging of the punctum. Gentle eversion of the medial part of the lower lid was performed to expose the lower lid punctum, so the vertical canaliculus was brought to be at an axial plain without undue stretching or pressure to the lower lid. Line scan was the used examination scan, containing 1020 A-scans/line, and is 8mm in length.
Measurements of the external punctal diameter, internal punctal diameter, and punctal depth were performed on the B-scan image of the lower punctum (by selecting it from the Review window), using distance measurement tool. External punctal diameter was measured as a line connecting highest points on the medial and lateral punctal walls. Internal punctal diameter was measured as a horizontal line just above the narrowing. The distance between the line representing the external punctal diameter and the floor of the punctum was calculated and referred to the punctal depth
Results:
Data wil be collected and statistically analysed
- Conditions
- Punctal Stenosis
- Being tested
- Anterior segment OCT
- Keywords
- acquired punctal stenosis, epiphora, lower punctum, AS-OCT
- Medical subject headings
- Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior segment OCTDevice
Also called (RTVue model-RT100, with cornea/anterior module lens (CAM system )
lower punctum examination by AS-OCT
| Study group | Role | What they receive |
|---|---|---|
| Patients with acquired punctal stenosis | Patients with acquired punctal stenosis with epiphora Receives: Device: Anterior segment OCT | |
| Control subjects | normal subjects, without evidence of any punctal abnormalities. Receives: Device: Anterior segment OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower punctum dimensions in cases with acquired punctual stenosis, compared with lower punctal dimensions in normal subjects
External punctum diameter measured in µm, internal punctum diameter, measured in µ m, punctal depth measured in µ m
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Punctal StenosisStudies of the same condition, open and under way.
- More trials run by Minia 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Radi AttaAllah, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498144
- Sponsor's protocol ID
- 62-2/2018
- Status last verified
- Apr 2018
- First submitted
- 2 Apr 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soiberman U, Kakizaki H, Selva D, Leibovitch I. Punctal stenosis: definition, diagnosis, and treatment. Clin Ophthalmol. 2012;6:1011-8. doi: 10.2147/OPTH.S31904. Epub 2012 Jul 3.
PubMed 22848141Kakizaki H, Takahashi Y, Iwaki M, Nakano T, Asamoto K, Ikeda H, Goto E, Selva D, Leibovitch I. Punctal and canalicular anatomy: implications for canalicular occlusion in severe dry eye. Am J Ophthalmol. 2012 Feb;153(2):229-237.e1. doi: 10.1016/j.ajo.2011.07.010. Epub 2011 Oct 6.
PubMed 21982102Kashkouli MB, Pakdel F, Kiavash V. Assessment and management of proximal and incomplete symptomatic obstruction of the lacrimal drainage system. Middle East Afr J Ophthalmol. 2012 Jan;19(1):60-9. doi: 10.4103/0974-9233.92117.
PubMed 22346116Wawrzynski JR, Smith J, Sharma A, Saleh GM. Optical coherence tomography imaging of the proximal lacrimal system. Orbit. 2014 Dec;33(6):428-32. doi: 10.3109/01676830.2014.949793. Epub 2014 Sep 12.
PubMed 25215411
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acquired Punctal Stenosis by Using Anterior Segment Optical Coherence Tomography (AS-OCT)
- ClinicalTrials.gov ID
- NCT03498144
- Acronym / sponsor ID
- 62-2/2018
- Conditions
- Punctal Stenosis
- Keywords
- acquired punctal stenosis, epiphora, lower punctum, AS-OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 13 Apr 2018 (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.
Purpose of the study
To evaluate the lower puntum dimensions in cases of acquired punctal stenosis(APS), using anterior segment optical coherence tomography (AS-OCT).
Detailed description
(B)Examination:
- External examination: should be done to rule out causes of watering other than punctal stenosis (facial palsy, lacrimal pump failure, swelling in lacrimal sac area and regurge test)
- Slit lamp examination: for tear meniscus, lid margin, conjunctiva and punctual orifice
- Fluorescein dye disappearance test: performed with a drop of 2% fluorescein in lower conjunctival sac, patient is instructed not to wipe the eyes. After 5 minutes, presence of staining in the tear film is assessed with cobalt blue filter.
- Probing and lacrimal syringing, if patent confirms punctal stenosis to be the cause of epiphora rather than block in the lower lacrimal drainage system.
- Anterior segment optical coherence tomography examination (AS-OCT) for the lower punctum: measuring the outer puntcal diametre, inner punctal diameter and punctal depth.
Examination of the lower punctum was performed using Spectral Domain OCT machine; RTVue model-RT100 CAM system (Optovue Inc., Fremont, CA, USA) version 6.2, by attaching the cornea/anterior module lens (CAM). CAM lens has a wide-angle, high-magnification lens of 10 mm working distance. The axial resolution was 5 μm, and the lateral resolution was 8 μm. The scan beam has wavelength of 840 ± 10 nm. The two red external illumination (light emitting diode ) LED on headrest were approximated on each side of the lower punctum for proper illumination and imaging of the punctum. Gentle eversion of the medial part of the lower lid was performed to expose the lower lid punctum, so the vertical canaliculus was brought to be at an axial plain without undue stretching or pressure to the lower lid. Line scan was the used examination scan, containing 1020 A-scans/line, and is 8mm in length.
Measurements of the external punctal diameter, internal punctal diameter, and punctal depth were performed on the B-scan image of the lower punctum (by selecting it from the Review window), using distance measurement tool. External punctal diameter was measured as a line connecting highest points on the medial and lateral punctal walls. Internal punctal diameter was measured as a horizontal line just above the narrowing. The distance between the line representing the external punctal diameter and the floor of the punctum was calculated and referred to the punctal depth
Results:
Data wil be collected and statistically analysed
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with acquired punctal stenosis | – | Device: Anterior segment OCTPatients with acquired punctal stenosis with epiphora |
| Control subjects | – | Device: Anterior segment OCTnormal subjects, without evidence of any punctal abnormalities. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults with acquired punctal stenosis
Key inclusion criteria (1 listed)
- Patients with acquired punctal stenosis
Key exclusion criteria (7 listed)
- Punctal agenesis
- Congenital punctal stenosis
- Allergic occlusion
- Lid malposition
- Canalicular, nasolacrimal, sac and duct obstruction
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 |
|---|---|---|
| Anterior segment OCTAlso: (RTVue model-RT100, with cornea/anterior module lens (CAM system )lower punctum examination by AS-OCT | Device | Control subjects, Patients with acquired punctal stenosis |
Primary outcome
Lower punctum dimensions in cases with acquired punctual stenosis, compared with lower punctal dimensions in normal subjects
Time frame: one month
External punctum diameter measured in µm, internal punctum diameter, measured in µ m, punctal depth measured in µ m
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Background: PubMed 22848141Soiberman U, Kakizaki H, Selva D, Leibovitch I. Punctal stenosis: definition, diagnosis, and treatment. Clin Ophthalmol. 2012;6:1011-8. doi: 10.2147/OPTH.S31904. Epub 2012 Jul 3.
- Background: PubMed 21982102Kakizaki H, Takahashi Y, Iwaki M, Nakano T, Asamoto K, Ikeda H, Goto E, Selva D, Leibovitch I. Punctal and canalicular anatomy: implications for canalicular occlusion in severe dry eye. Am J Ophthalmol. 2012 Feb;153(2):229-237.e1. doi: 10.1016/j.ajo.2011.07.010. Epub 2011 Oct 6.
- Background: PubMed 22346116Kashkouli MB, Pakdel F, Kiavash V. Assessment and management of proximal and incomplete symptomatic obstruction of the lacrimal drainage system. Middle East Afr J Ophthalmol. 2012 Jan;19(1):60-9. doi: 10.4103/0974-9233.92117.
- Background: PubMed 25215411Wawrzynski JR, Smith J, Sharma A, Saleh GM. Optical coherence tomography imaging of the proximal lacrimal system. Orbit. 2014 Dec;33(6):428-32. doi: 10.3109/01676830.2014.949793. Epub 2014 Sep 12.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Punctal Stenosis, run by Minia 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 1 inclusion and 7 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 13 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba AttaAllah, MD (+201002554107, heba.ali@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower punctum dimensions in cases with acquired punctual stenosis, compared with lower punctal dimensions in normal subjects (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03498144, which also lists 4 linked publications.
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 13 Apr 2018.