Diagnosis of Acquired Punctal Stenosis Using Anterior Segment Optical Coherence Tomography

April 6, 2018 updated by: Heba Radi AttaAllah, Minia University

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with acquired punctal stenosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2018

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (ACTUAL)

April 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62-2/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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