This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
36
Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.
Ophthalmology Department
Monterrey, Nuevo León, Mexico
RECRUITING1. Effectiveness
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
Time frame: Baseline, 2 weeks, 4 weeks, 3 months and 6 months
Change in lower tear meniscus heigh
Change in lower tear meniscus height measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement.
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in lower tear meniscus area
Change in lower tear meniscus area measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement.
Time frame: 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)
The OSDI is a validated 12-item questionnaire evaluating dry eye symptoms and their impact on vision-related functioning across three domains: ocular symptoms, visual function, and environmental triggers. Each item is scored on a 5-point scale (0 = none of the time to 4 = all of the time). The total OSDI score is calculated as: OSDI= number of questions answered (sum of scores)×25 Scores range from 0 to 100, with higher scores indicating greater disability. Severity categories are: normal (0-12), mild (13-22), moderate (23-32), and severe (33-100).
Time frame: 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.
The SANDE is a validated, patient-reported outcome measuring dry eye symptom burden using two 100-mm visual analog scales assessing frequency and severity of symptoms (0 = none, 100 = maximal). The composite SANDE score is calculated as the square root of the product of frequency and severity scores: Higher scores indicate worse symptoms.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in tear film break-up time (TFBUT).
Change in tear film break-up time measured with fluorescein after upper punctal plug placement.
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in non-invasive tear break-up time (NIBUT).
Change in non-invasive tear break-up time measured using Keratograph after upper punctal plug placement.
Time frame: Baseline 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).
The SICCA OSS is a standardized clinical grading system developed by the Sjögren's International Collaborative Clinical Alliance to quantify ocular surface epithelial damage using vital dyes. The score combines fluorescein corneal staining and lissamine green conjunctival staining in each eye.
Time frame: 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
The NEI corneal fluorescein staining score is a standardized slit-lamp-based grading system used to quantify corneal epithelial damage after fluorescein instillation. The cornea is divided into five regions (central, superior, inferior, nasal, and temporal). Each region is graded on a 0 to 3 scale based on staining density and extent: 0 = no staining 1. = sparse punctate staining 2. = moderate/dense punctate staining 3. = severe staining or coalescent areas The total NEI score is the sum of all regions, ranging from 0 to 15, with higher scores indicating greater corneal epithelial damage.
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in Schirmer I test results.
Change in tear production measured using the Schirmer I test with and without anesthesia after upper punctal plug placement.
Time frame: Baseline to 3 months after upper punctal plug placement.
Change in corneal sensitivity.
Change in corneal sensitivity measured by corneal esthesiometry after upper punctal plug placement.
Time frame: Baseline to 3 months after upper punctal plug placement.
Incidence of epiphora after upper punctal plug placement.
Incidence of epiphora reported after upper punctal plug placement during the follow-up period.
Time frame: Up to 3 months after upper punctal plug placement.
Upper punctal plug retention rate.
Proportion of upper punctal plugs remaining in place during the follow-up period after placement.
Time frame: Up to 3 months after upper punctal plug placement.