Diagnosis of Acquired Punctal Stenosis Using Anterior Segment Optical Coherence Tomography

NCT ID: NCT03498144

Last Updated: 2018-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-07-01

Brief Summary

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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

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(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

Conditions

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Punctal Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acquired punctal stenosis

Patients with acquired punctal stenosis with epiphora

Anterior segment OCT

Intervention Type DEVICE

lower punctum examination by AS-OCT

Control subjects

normal subjects, without evidence of any punctal abnormalities.

Anterior segment OCT

Intervention Type DEVICE

lower punctum examination by AS-OCT

Interventions

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Anterior segment OCT

lower punctum examination by AS-OCT

Intervention Type DEVICE

Other Intervention Names

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(RTVue model-RT100, with cornea/anterior module lens (CAM system )

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Heba Radi AttaAllah

Lecturer of Ophthalmology/ Ophthalmology department/Faculty of Medicine/(Principal Investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Heba AttaAllah, MD

Role: CONTACT

+201002554107

References

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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.

Reference Type BACKGROUND
PMID: 22848141 (View on PubMed)

Kakizaki 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.

Reference Type BACKGROUND
PMID: 21982102 (View on PubMed)

Kashkouli 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.

Reference Type BACKGROUND
PMID: 22346116 (View on PubMed)

Wawrzynski 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.

Reference Type BACKGROUND
PMID: 25215411 (View on PubMed)

Other Identifiers

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62-2/2018

Identifier Type: -

Identifier Source: org_study_id

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