Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- 1. Effectiveness
Study Overview
Brief Summary
This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.
Detailed Description
This prospective, consecutive, interventional, longitudinal, case series study includes patients with aqueous-deficient dry eye disease who have inferior punctal occlusion. The study aims to evaluate the effect of superior lacrimal punctal occlusion with a plug dry eye symptoms and signs. Assessments will be performed at baseline and at 2 weeks, 4 weeks, 3 months, and 6 months following superior punctal occlusion
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of both sexes
- •One or both eyes may be included
- •Inferior lacrimal punctum occluded (with a punctal plug or cauterization), clinically sealed under slit-lamp examination
- •Functional superior lacrimal punctum
- •Aqueous-deficient dry eye (such as Sjögren's disease, graft-versus-host disease, or primary dry eye disease.)
- •Age >18 years
- •OSDI score >13 and one of the following signs: Tear film markers (Fluorescein tear break up-time <5, First non-invasive tear breakup time <10, Schirmer test without anesthesia <10 mm, Schirmer test with anesthesia <10 mm), Ocular surface markers (corneal staining >5 spots or conjunctival staining >9 spots).
Exclusion Criteria
- •Active ocular surface infection.
- •Patients who are unwilling to participate or to provide written informed consent.
Arms & Interventions
1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who
1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.
Intervention: Punctal plug occlusion (Procedure)
Outcomes
Primary Outcomes
1. Effectiveness
Time Frame: Baseline, 2 weeks, 4 weeks, 3 months and 6 months
To evaluate signs and symptoms of dry eye, after superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum at baseline, 2 weeks, 4 weeks, 3 months and 6 months
Secondary Outcomes
- Change in lower tear meniscus heigh(Baseline to 3 months after upper punctal plug placement.)
- Change in lower tear meniscus area(Baseline to 3 months after upper punctal plug placement.)
- Change from baseline in dry eye severity as assessed by the Ocular Surface Disease Index (OSDI)(Baseline to 3 months after upper punctal plug placement.)
- Change from baseline in dry eye symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) scale.(Baseline to 3 months after upper punctal plug placement.)
- Change in tear film break-up time (TFBUT).(Baseline to 3 months after upper punctal plug placement.)
- Change in non-invasive tear break-up time (NIBUT).(Baseline to 3 months after upper punctal plug placement.)
- Upper punctal plug retention rate.(Up to 3 months after upper punctal plug placement.)
- Change from baseline in ocular surface damage as assessed by the SICCA Ocular Surface Staining Score (OSS).(Baseline to 3 months after upper punctal plug placement.)
- Change from baseline in corneal epithelial damage as assessed by the National Eye Institute Corneal Fluorescein Staining (NEI) score(Baseline to 3 months after upper punctal plug placement.)
- Change in Schirmer I test results.(Baseline to 3 months after upper punctal plug placement.)
- Change in corneal sensitivity.(Baseline to 3 months after upper punctal plug placement.)
- Incidence of epiphora after upper punctal plug placement.(Up to 3 months after upper punctal plug placement.)
Investigators
Karim Mohamed-Noriega
Principal Investigator
Universidad Autonoma de Nuevo Leon