Back to resultsOCT Guided Punctal Stenosis Management
Primary Purpose
Epiphora Due to Insufficient Drainage
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Methylprednisolone eyedrops
Sponsored by
About this trial
This is an interventional treatment trial for Epiphora Due to Insufficient Drainage
Eligibility Criteria
Inclusion Criteria:
- Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.
Exclusion Criteria:
- Previous lacrimal surgery.
- Lid margin malposition such as ectropion, entropion or lid retraction.
- Medial lid masses obscuring punctum.
- History of ocular trauma involving lid margin or punctum.
Sites / Locations
- Amr Awara
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
Methylprednisolone eye drops
distilled water eyedrops
Arm Description
Preservative free steroids methylprednisolone 5% eye drops (prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company) was prepared and given for all enrolled cases by the following regimen 5 times/day for 5 days with gradual decrease every third day over the following 2 weeks
Distilled water eyedrops instilled 3 times per day for two weeks
Outcomes
Primary Outcome Measures
punctal opening
evaluation of punctalopening by OCT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04318652
Brief Title
OCT Guided Punctal Stenosis Management
Official Title
The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2, 2018 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.
Detailed Description
The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora Due to Insufficient Drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone eye drops
Arm Type
Other
Arm Description
Preservative free steroids methylprednisolone 5% eye drops (prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company) was prepared and given for all enrolled cases by the following regimen 5 times/day for 5 days with gradual decrease every third day over the following 2 weeks
Arm Title
distilled water eyedrops
Arm Type
Placebo Comparator
Arm Description
Distilled water eyedrops instilled 3 times per day for two weeks
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone eyedrops
Intervention Description
instillation of methylprednisolone eye drops
Primary Outcome Measure Information:
Title
punctal opening
Description
evaluation of punctalopening by OCT
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.
Exclusion Criteria:
Previous lacrimal surgery.
Lid margin malposition such as ectropion, entropion or lid retraction.
Medial lid masses obscuring punctum.
History of ocular trauma involving lid margin or punctum.
Facility Information:
Facility Name
Amr Awara
City
Tanta
State/Province
Gharbeyia
ZIP/Postal Code
3111
Country
Egypt
12. IPD Sharing Statement
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OCT Guided Punctal Stenosis Management
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