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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who | Experimental | 1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Punctal plug occlusion | Procedure | Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 2 weeks, 4 weeks, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 3 months after upper punctal plug placement. |
| Change in lower tear meniscus area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karim Mohamed-Noriega, Dr. med. | Contact | +52 8113404960 | 8514 | karim.mohamednr@uanl.edu.mx |
| Name | Affiliation | Role |
|---|---|---|
| Karim Mohamed-Noriega, Dr. med. | Universidad Autonoma de Nuevo Leon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Department | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23649850 | Background | Qiu W, Liu Z, Ao M, Li X, Wang W. Punctal plugs versus artificial tears for treating primary Sjogren's syndrome with keratoconjunctivitis SICCA: a comparative observation of their effects on visual function. Rheumatol Int. 2013 Oct;33(10):2543-8. doi: 10.1007/s00296-013-2769-1. Epub 2013 May 7. | |
| 41005521 | Background |
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Prospective, consecutive, interventional case series study of patients with aqueous-deficient dry eye disease.
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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) | 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. | 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). | 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). | 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). | 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 | 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
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. | 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. | 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. | 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. | Proportion of upper punctal plugs remaining in place during the follow-up period after placement. | Up to 3 months after upper punctal plug placement. |
| Perez VL, Chen W, Craig JP, Dogru M, Jones L, Stapleton F, Wolffsohn JS, Sullivan DA. TFOS DEWS III: Executive Summary. Am J Ophthalmol. 2026 Feb;282:135-145. doi: 10.1016/j.ajo.2025.09.035. Epub 2025 Sep 24. |
| 26038339 | Background | Marcet MM, Shtein RM, Bradley EA, Deng SX, Meyer DR, Bilyk JR, Yen MT, Lee WB, Mawn LA. Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology. Ophthalmology. 2015 Aug;122(8):1681-7. doi: 10.1016/j.ophtha.2015.04.034. Epub 2015 May 30. |
| 26850527 | Background | Lanza NL, Valenzuela F, Perez VL, Galor A. The Matrix Metalloproteinase 9 Point-of-Care Test in Dry Eye. Ocul Surf. 2016 Apr;14(2):189-95. doi: 10.1016/j.jtos.2015.10.004. Epub 2016 Feb 2. |
| 23317650 | Background | Kaido M, Ishida R, Dogru M, Tsubota K. Comparison of retention rates and complications of 2 different types of silicon lacrimal punctal plugs in the treatment of dry eye disease. Am J Ophthalmol. 2013 Apr;155(4):648-653, 653.e1. doi: 10.1016/j.ajo.2012.10.024. Epub 2013 Jan 11. |
| 38289716 | Background | Hallali G, Guindolet D, Gabison EE, Cochereau I, Doan S. Immediate and Delayed Effects of Punctal Plug Insertion on Tear Meniscus Height in Severe Aqueous-Deficient Dry Eye. Cornea. 2024 Jul 1;43(7):890-894. doi: 10.1097/ICO.0000000000003477. Epub 2024 Jan 30. |
| 28736335 | Background | Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20. |
| 20463310 | Background | Chen F, Wang J, Chen W, Shen M, Xu S, Lu F. Upper punctal occlusion versus lower punctal occlusion in dry eye. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5571-7. doi: 10.1167/iovs.09-5097. Epub 2010 May 12. |
| 19933200 | Background | Chen F, Shen M, Chen W, Wang J, Li M, Yuan Y, Lu F. Tear meniscus volume in dry eye after punctal occlusion. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):1965-9. doi: 10.1167/iovs.09-4349. Epub 2009 Nov 20. |
| 18434839 | Background | Burgess PI, Koay P, Clark P. SmartPlug versus silicone punctal plug therapy for dry eye: a prospective randomized trial. Cornea. 2008 May;27(4):391-4. doi: 10.1097/ICO.0b013e318160d030. |
| 18723140 | Background | Boldin I, Klein A, Haller-Schober EM, Horwath-Winter J. Long-term follow-up of punctal and proximal canalicular stenoses after silicone punctal plug treatment in dry eye patients. Am J Ophthalmol. 2008 Dec;146(6):968-72.e1. doi: 10.1016/j.ajo.2008.06.028. Epub 2008 Aug 23. |
| 11162976 | Background | Balaram M, Schaumberg DA, Dana MR. Efficacy and tolerability outcomes after punctal occlusion with silicone plugs in dry eye syndrome. Am J Ophthalmol. 2001 Jan;131(1):30-6. doi: 10.1016/s0002-9394(00)00620-6. |
| 33861367 | Background | Ali MJ, Singh S. Optical coherence tomography and the proximal lacrimal drainage system: a major review. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3197-3208. doi: 10.1007/s00417-021-05175-3. Epub 2021 Apr 16. |
| 35054155 | Background | Ahn H, Ji YW, Jun I, Kim TI, Lee HK, Seo KY. Comparison of Treatment Modalities for Dry Eye in Primary Sjogren's Syndrome. J Clin Med. 2022 Jan 17;11(2):463. doi: 10.3390/jcm11020463. |