Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.

4 mai 2026 mis à jour par: Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon

Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.

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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Estimé)

36

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Mexique
    • Nuevo León
      • Monterrey, Nuevo León, Mexique, 64460
        • Recrutement
        • Ophthalmology Department
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: Punctal plug occlusion
Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
1. Effectiveness
Délai: 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
Baseline, 2 weeks, 4 weeks, 3 months and 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in lower tear meniscus heigh
Délai: 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.
Baseline to 3 months after upper punctal plug placement.
Change in lower tear meniscus area
Délai: 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.
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)
Délai: 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).
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.
Délai: 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.
Baseline to 3 months after upper punctal plug placement.
Change in tear film break-up time (TFBUT).
Délai: Baseline to 3 months after upper punctal plug placement.
Change in tear film break-up time measured with fluorescein after upper punctal plug placement.
Baseline to 3 months after upper punctal plug placement.
Change in non-invasive tear break-up time (NIBUT).
Délai: 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.
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).
Délai: 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.
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
Délai: 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.
Baseline to 3 months after upper punctal plug placement.
Change in Schirmer I test results.
Délai: 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.
Baseline to 3 months after upper punctal plug placement.
Change in corneal sensitivity.
Délai: Baseline to 3 months after upper punctal plug placement.
Change in corneal sensitivity measured by corneal esthesiometry after upper punctal plug placement.
Baseline to 3 months after upper punctal plug placement.
Incidence of epiphora after upper punctal plug placement.
Délai: Up to 3 months after upper punctal plug placement.
Incidence of epiphora reported after upper punctal plug placement during the follow-up period.
Up to 3 months after upper punctal plug placement.
Upper punctal plug retention rate.
Délai: Up to 3 months after upper punctal plug placement.
Proportion of upper punctal plugs remaining in place during the follow-up period after placement.
Up to 3 months after upper punctal plug placement.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universidad Autonoma de Nuevo Leon

Les enquêteurs

  • Chercheur principal: Karim Mohamed-Noriega, Dr. med., Universidad Autonoma de Nuevo Leon

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • 14. Qiu, W., Liu, Z., Ao, M., Li, X., & Wang, W. (2013). Punctal plugs versus artificial tears for treating primary Sjögren's syndrome with keratoconjunctivitis SICCA: A comparative observation of their effects on visual function. Rheumatology International, 33(10), 2543-2548. https://doi.org/10.1007/s00296-013-2769-1
  • 13. Perez, V. L., Chen, W., Craig, J. P., Dogru, M., Jones, L., Stapleton, F., Wolffsohn, J. S., & Sullivan, D. A. (2025). TFOS DEWS III: Executive Summary. American Journal of Ophthalmology. https://doi.org/10.1016/j.ajo.2025.09.035
  • 12. Marcet, M. M., Shtein, R. M., Bradley, E. A., Deng, S. X., Meyer, D. R., Bilyk, J. R., Yen, M. T., Lee, W. B., Mawn, L. A., & Lum, F. (2015a). Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome A Report by the American Academy of Ophthalmology. Ophthalmology, 122(8), 1681-1687. https://doi.org/10.1016/j.ophtha.2015.04.034
  • 11. Lanza NL, Valenzuela F, Perez VL, Galor A. The Matrix Metalloproteinase 9 Point-of-Care Test in Dry Eye. Ocul Surf [Internet]. 2016 Apr 1;14(2):189-95. Available from: https://linkinghub.elsevier.com/retrieve/pii/S1542012416000082
  • 10. Kaido, M., Ishida, R., Dogru, M., & Tsubota, K. (2013). Comparison of retention rates and complications of 2 different types of silicon lacrimal punctal plugs in the treatment of dry eye disease. American Journal of Ophthalmology, 155(4). https://doi.org/10.1016/j.ajo.2012.10.024
  • 9. Hallali, G., Guindolet, D., Gabison, E. E., Cochereau, I., & Doan, S. (2024a). Immediate and Delayed Effects of Punctal Plug Insertion on Tear Meniscus Height in Severe Aqueous-Deficient Dry Eye. www.corneajrnl.com
  • 8. Craig, J. P., Nichols, K. K., Akpek, E. K., Caffery, B., Dua, H. S., Joo, C. K., Liu, Z., Nelson, J. D., Nichols, J. J., Tsubota, K., & Stapleton, F. (2017a). TFOS DEWS II Definition and Classification Report. In Ocular Surface (Vol. 15, Issue 3, pp. 276-283). Elsevier Inc. https://doi.org/10.1016/j.jtos.2017.05.008
  • 7. Chen, F., Wang, J., Chen, W., Shen, M., Xu, S., & Lu, F. (2010). Upper punctal occlusion versus lower punctal occlusion in dry eye. Investigative Ophthalmology and Visual Science, 51(11), 5571-5577. https://doi.org/10.1167/iovs.09-5097
  • 6. Chen, F., Shen, M., Chen, W., Wang, J., Li, M., Yuan, Y., & Lu, F. (2010). Tear meniscus volume in dry eye after punctal occlusion. Investigative Ophthalmology and Visual Science, 51(4), 1965-1969. https://doi.org/10.1167/iovs.09-4349
  • 5. Burgess, P. I., Koay, P., & Clark, P. (n.d.). SmartPlug Versus Silicone Punctal Plug Therapy for Dry Eye A Prospective Randomized Trial.
  • 4. Boldin, I., Klein, A., Haller-Schober, E. M., & Horwath-Winter, J. (2008). Long-term Follow-up of Punctal and Proximal Canalicular Stenoses After Silicone Punctal Plug Treatment in Dry Eye Patients. American Journal of Ophthalmology, 146(6). https://doi.org/10.1016/j.ajo.2008.06.028
  • 3. Balaram, M., Schaumberg, D. A., & Dana, M. R. (2001). Efficacy and Tolerability Outcomes After Punctal Occlusion With Silicone Plugs in Dry Eye Syndrome.
  • 2. Ali, M. J., & Singh, S. (2021). Optical coherence tomography and the proximal lacrimal drainage system: a major review. In Graefe's Archive for Clinical and Experimental Ophthalmology (Vol. 259, Issue 11, pp. 3197-3208). Springer Science and Business Media Deutschland GmbH. https://doi.org/10.1007/s00417-021-05175-3
  • 1. Ahn, H., Ji, Y. W., Jun, I., Kim, T. I., Lee, H. K., & Seo, K. Y. (2022). Comparison of Treatment Modalities for Dry Eye in Primary Sjogren's Syndrome. Journal of Clinical Medicine, 11(2). https://doi.org/10.3390/jcm11020463

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 février 2026

Achèvement primaire (Estimé)

1 octobre 2026

Achèvement de l'étude (Estimé)

1 novembre 2026

Dates d'inscription aux études

Première soumission

12 février 2026

Première soumission répondant aux critères de contrôle qualité

4 mai 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2026

Dernière vérification

1 février 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • OF25-00001

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner