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Diagnosis of Acquired Punctal Stenosis Using Anterior Segment Optical Coherence Tomography

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ClinicalTrials.gov Identifier: NCT03498144
Recruitment Status : Not yet recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Heba Radi AttaAllah, Minia University

Brief 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).


Condition or disease Intervention/treatment
Punctal Stenosis Device: Anterior segment OCT

Detailed Description:

(B)Examination:

  1. 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)
  2. Slit lamp examination: for tear meniscus, lid margin, conjunctiva and punctual orifice
  3. 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.
  4. Probing and lacrimal syringing, if patent confirms punctal stenosis to be the cause of epiphora rather than block in the lower lacrimal drainage system.
  5. 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


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Acquired Punctal Stenosis by Using Anterior Segment Optical Coherence Tomography (AS-OCT)
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : July 1, 2018

Group/Cohort Intervention/treatment
Patients with acquired punctal stenosis
Patients with acquired punctal stenosis with epiphora
Device: Anterior segment OCT
lower punctum examination by AS-OCT
Other Name: (RTVue model-RT100, with cornea/anterior module lens (CAM system )

Control subjects
normal subjects, without evidence of any punctal abnormalities.
Device: Anterior segment OCT
lower punctum examination by AS-OCT
Other Name: (RTVue model-RT100, with cornea/anterior module lens (CAM system )




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults with acquired punctal stenosis
Criteria

Inclusion Criteria:

Patients with acquired punctal stenosis

Exclusion Criteria:

  1. Punctal agenesis
  2. Congenital punctal stenosis
  3. Allergic occlusion
  4. Lid malposition
  5. Canalicular, nasolacrimal, sac and duct obstruction
  6. Previous eyelid or lacrimal drainage surgery
  7. Untreated conjunctivitis, blepharitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498144


Contacts
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Contact: Heba AttaAllah, MD +201002554107 heba.ali@mu.edu.eg

Sponsors and Collaborators
Minia University

Publications:
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Responsible Party: Heba Radi AttaAllah, Lecturer of Ophthalmology/ Ophthalmology department/Faculty of Medicine/(Principal Investigator), Minia University
ClinicalTrials.gov Identifier: NCT03498144     History of Changes
Other Study ID Numbers: 62-2/2018
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heba Radi AttaAllah, Minia University:
acquired punctal stenosis
epiphora
lower punctum
AS-OCT
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical