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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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