AS OCT Evaluation for Perforated Punctual Plugs

NCT04624022 | Unknown

• 1 other identifier: 620-5/2020
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Punctal Stenosis

Keywords

Punctual stenosis; Perforated Lacrimal Punctal Plugs; AS-OCT

Outcome Measures

Primary Outcomes (5)

• Evaluation of the fitting of implanted perforated lacrimal plugs

  Either plug is in place or rotated

  first week post-operatively

• Evaluation of the patency of the plugs

  Either plug is patent or occluded

  first week post-operatively

• Evaluation any contents within the plugs

  Blood/ Tears/ Debris

  first week post-operatively

• Evaluation of the lower tear film height

  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

  Either within the lower half or upper half of the plug

  first week post-operatively

Interventions

Anterior segment optical coherent tomography DIAGNOSTIC_TEST

Examination of the implanted perforated lacrimal plugs using anterior segment optical coherent tomography

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Patients who are not willing to participate in the study

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Ophthalmology department/ Minia University Hospital/Minia University

Minya, 61111, Egypt

RECRUITING

Related Publications (1)

• Abdallah RMA, Elshafei AMK, AttaAllah HR. Evaluation of implanted perforated lacrimal punctal plugs using anterior segment optical coherence tomography. Eye Vis (Lond). 2021 Oct 3;8(1):36. doi: 10.1186/s40662-021-00259-x.

  PMID: 34600582 DERIVED

Study Officials

• Heba AttaAllah, MD

  Faculty of Medicine, Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba R AttaAllah, MD

CONTACT

00201002554107; heba.ali@mu.edu.ed

Raafat M Abdallah, MD

CONTACT

00201224481312; raafat.abdelrahman@mu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant prof of Ophthalmology

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 10, 2020
• Study Start: May 11, 2020
• Primary Completion: November 5, 2020
• Study Completion: November 15, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)