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Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.

ConditionsDEDAqueous-deficient Dry Eye Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Autonoma de Nuevo Leon

About this trial

This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active ocular surface infection.

Patients who are unwilling to participate or to provide written informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • Punctal plug occlusion

    Procedure/Surgery

    Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: 1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye whoExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1. 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

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Time frame
Baseline to 3 months after upper punctal plug placement.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Autonoma de Nuevo Leon

Lead sponsor

Source ClinicalTrials.gov
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