- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04624022
AS OCT Evaluation for Perforated Punctual Plugs
Evaluation of Implanted Perforated Lacrimal Punctal Plugs Using Anterior Segment Optical Coherence Tomography.
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Heba R AttaAllah, MD
- Phone Number: 00201002554107
- Email: heba.ali@mu.edu.ed
Study Contact Backup
- Name: Raafat M Abdallah, MD
- Phone Number: 00201224481312
- Email: raafat.abdelrahman@mu.edu.eg
Study Locations
-
-
-
Minya, Egypt, 61111
- Recruiting
- Ophthalmology department/ Minia University Hospital/Minia University
-
Contact:
- Heba R AttaAllah, MD
- Email: heba.ali@mu.edu.eg
-
Contact:
- Raafat Abdelrahman, MD
- Email: raafat.abdelrahman@mu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Heba AttaAllah, MD, Faculty of Medicine, Minia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 620-5/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Punctal Stenosis
-
Minia UniversityUnknown
-
Al-Azhar UniversityCompleted
-
Farwaniya HospitalCompletedManagement of Punctal StenosisKuwait
-
Rabin Medical CenterUnknownContact Lens and Punctal Plug in Preventing Corneal InjuriesIsrael
-
Sutherland Medical CenterActive, not recruitingSpinal Stenosis Lumbar | Spinal Canal StenosisPoland
-
Massachusetts General HospitalCompletedLumbar Spinal Stenosis | Thoracic Spinal StenosisUnited States
-
RTI SurgicalCompletedSpinal Disease | Spinal Instability | Spinal Stenosis Occipito-Atlanto-Axial | Spinal Stenosis Cervical | Spinal Stenosis Cervicothoracic RegionUnited States
-
Azienda Usl di BolognaRecruitingLumbar Spinal Stenosis | Degenerative Lumbar Spinal StenosisItaly
-
DK Medical Technology (Suzhou) Co., Ltd.CompletedPopliteal Artery Stenosis | Femoral Artery StenosisChina
-
University Hospital, Basel, SwitzerlandKlinik für Radiologie und Nuklearmedizin, University Hospital BaselCompletedLumbar Spinal Stenosis | Symptomatic Lumbar Spinal StenosisSwitzerland
Clinical Trials on Anterior segment optical coherent tomography
-
Vienna Institute for Research in Ocular SurgeryRecruitingMap Dot Fingerprint DystrophyAustria
-
Young-Hak Kim, MD, PhDAbbott Medical DevicesTerminatedCoronary Artery DiseaseKorea, Republic of
-
Assiut UniversityUnknownFemtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal Flaps
-
University of Texas Southwestern Medical CenterCompletedCorneal Edema Secondary to Corneal Endothelial DystrophyUnited States
-
Minia UniversityRecruitingJuvenile Systemic Lupus ErythematosusEgypt
-
Minia UniversityCompleted
-
Duke UniversityTerminatedPrimary Open Angle Glaucoma | Cataracts | Exfoliation SyndromeUnited States
-
Baskent UniversityCompleted
-
Assiut UniversityNot yet recruitingCorneal Ectasia of Both Eyes