Aqueous-deficient Dry Eye Disease, DED
Conditions
Keywords
Aqueous-deficient dry eye disease, DED, Punctual plug, Superior punctual plug
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
Interventions
PROCEDUREPunctal plug occlusion
Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.
Sponsors
Universidad Autonoma de Nuevo Leon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, consecutive, interventional case series study of patients with aqueous-deficient dry eye disease.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Effectiveness | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in lower tear meniscus heigh | Baseline to 3 months after upper punctal plug placement. | Change in lower tear meniscus height measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement. |
| Change in lower tear meniscus area | Baseline to 3 months after upper punctal plug placement. | Change in lower tear meniscus area measured using Keratograph and optical coherence tomography (OCT) 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. | 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). |
| 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. | 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. |
| Change in tear film break-up time (TFBUT). | Baseline to 3 months after upper punctal plug placement. | Change in tear film break-up time measured with fluorescein after upper punctal plug placement. |
| Change in non-invasive tear break-up time (NIBUT). | Baseline to 3 months after upper punctal plug placement. | Change in non-invasive tear break-up time measured using Keratograph 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. | 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. |
| 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. | 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. |
| Change in Schirmer I test results. | Baseline to 3 months after upper punctal plug placement. | Change in tear production measured using the Schirmer I test with and without anesthesia after upper punctal plug placement. |
| Change in corneal sensitivity. | Baseline to 3 months after upper punctal plug placement. | Change in corneal sensitivity measured by corneal esthesiometry after upper punctal plug placement. |
| Incidence of epiphora after upper punctal plug placement. | Up to 3 months after upper punctal plug placement. | Incidence of epiphora reported after upper punctal plug placement during the follow-up period. |
| Upper punctal plug retention rate. | Up to 3 months after upper punctal plug placement. | Proportion of upper punctal plugs remaining in place during the follow-up period after placement. |
Countries
Mexico
Contacts
CONTACTKarim Mohamed-Noriega, Dr. med.
PRINCIPAL_INVESTIGATORKarim Mohamed-Noriega, Dr. med.
Universidad Autonoma de Nuevo Leon
Outcome results
None listed