AS OCT Evaluation for Perforated Punctual Plugs

Punctal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624022
• Other study ID #: 620-5/2020
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: November 2020
• Source: Minia University
• Contact: Heba R AttaAllah, MD
• Phone: 00201002554107
• Email: heba.ali[@]mu.edu.ed
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 15, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Punctal Stenosis

Intervention

Diagnostic Test:
• Anterior segment optical coherent tomography
Examination of the implanted perforated lacrimal plugs using anterior segment optical coherent tomography

Locations

Country	Name	City	State
Egypt	Ophthalmology department/ Minia University Hospital/Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the fitting of implanted perforated lacrimal plugs	Either plug is in place or rotated	first week post-operatively
Primary	Evaluation of the patency of the plugs	Either plug is patent or occluded	first week post-operatively
Primary	Evaluation any contents within the plugs	Blood/ Tears/ Debris	first week post-operatively
Primary	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
Primary	Evaluation of the tear level within the plug	Either within the lower half or upper half of the plug	first week post-operatively