AS OCT Evaluation for Perforated Punctual Plugs

November 5, 2020 updated by: Heba Radi AttaAllah, Minia University

Evaluation of Implanted Perforated Lacrimal Punctal Plugs Using Anterior Segment Optical Coherence Tomography.

Evaluation of the perforated punctal plugs after implantation in cases of punctal stenosis regarding position and patency in the early postoperative period (during the first operative weak)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective non randomized case series study included 50 eyes. The study is conducted on patients attending to the oculoplastic unit of ophthalmology department of Minia university hospital. Informed consents were obtained from the participants in this study. The study was adherent to the tenets of declaration of Heleniski.

Anterior segment optical coherence tomography(AS-OCT) was performed for the included patients after perforated plug implantation (during the first operative weak)

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with epiphora will be evaluated to exclude other causes than punctal stenosis. Perforated punctal plugs were implanted under topical anaesthesia. patients follow up and AS-OCT

Description

Inclusion Criteria:

  • Patients with punctal stenosis who will be treated by implantation of perorated punctal plugs

Exclusion Criteria:

  • Patients who are not willing to participate in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the fitting of implanted perforated lacrimal plugs
Time Frame: first week post-operatively
Either plug is in place or rotated
first week post-operatively
Evaluation of the patency of the plugs
Time Frame: first week post-operatively
Either plug is patent or occluded
first week post-operatively
Evaluation any contents within the plugs
Time Frame: first week post-operatively
Blood/ Tears/ Debris
first week post-operatively
Evaluation of the lower tear film height
Time Frame: first week post-operatively
measuring the tear film meniscus height at the lower lid margin (at the centre of the inferior limbus), height is measured in micrometers
first week post-operatively
Evaluation of the tear level within the plug
Time Frame: first week post-operatively
Either within the lower half or upper half of the plug
first week post-operatively

Collaborators and Investigators

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

Sponsor

Minia University

Investigators

  • Principal Investigator: Heba AttaAllah, MD, Faculty of medicine, 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 (Actual)

May 11, 2020

Primary Completion (Anticipated)

November 5, 2020

Study Completion (Anticipated)

November 15, 2020

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 620-5/2020

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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