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Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery
To asses ocular discomfort symptoms and signs and inflammatory biomarkers after preoperative topical cyclosporine 0.1% eye drops therapy in high risk elder population after a specific insult such as cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| young control | No Intervention | 25 patients < 65 years old without any prophylactic anti-inflammatory preoperative treatment | |
| control | No Intervention | 25 patients > 75 years old without any prophylactic anti-inflammatory preoperative treatment | |
| Study group | Experimental | 25 patients > 75 years old with prophylactic anti-inflammatory preoperative treatment |
|
| Vehicle group | Active Comparator | 25 patients > 75 years old with vehicle preoperative treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion | Drug | one cyclosporine 0.1% eye drop twice a day for 30 preoperative days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms Assessment Questionnaire iN Dry Eye | SANDE (frequency and severity scores; 0-100) | 4 months |
| National Eye Institute grading scale | NEI corneal staining ( n/15 score; 0-15) | 4 months |
| Rate of tears' production | Schirmer test (mm/5min) | 4 months |
| Tears Break Up Time | T-BUT (Seconds) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers' expression in conjunctival epithelial cells | HLA DR (molecular expression) | 4 months |
| Biomarkers' expression in conjunctival epithelial cells | ICAM-1 (molecular expression) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Campus Bio Medico | Rome | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30078540 | Background | Gupta PK, Drinkwater OJ, VanDusen KW, Brissette AR, Starr CE. Prevalence of ocular surface dysfunction in patients presenting for cataract surgery evaluation. J Cataract Refract Surg. 2018 Sep;44(9):1090-1096. doi: 10.1016/j.jcrs.2018.06.026. Epub 2018 Aug 2. | |
| 27627886 | Background | Kim JS, Lee H, Choi S, Kim EK, Seo KY, Kim TI. Assessment of the Tear Film Lipid Layer Thickness after Cataract Surgery. Semin Ophthalmol. 2018;33(2):231-236. doi: 10.1080/08820538.2016.1208764. Epub 2016 Sep 14. |
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| cationorm eye drops | Device | one cationorm eye drop twice a day for 30 preoperative days |
|
| 4 months |
| 28848324 | Background | Trattler WB, Majmudar PA, Donnenfeld ED, McDonald MB, Stonecipher KG, Goldberg DF. The Prospective Health Assessment of Cataract Patients' Ocular Surface (PHACO) study: the effect of dry eye. Clin Ophthalmol. 2017 Aug 7;11:1423-1430. doi: 10.2147/OPTH.S120159. eCollection 2017. |
| 29504953 | Background | Iglesias E, Sajnani R, Levitt RC, Sarantopoulos CD, Galor A. Epidemiology of Persistent Dry Eye-Like Symptoms After Cataract Surgery. Cornea. 2018 Jul;37(7):893-898. doi: 10.1097/ICO.0000000000001491. |
| 29926365 | Background | Kohli P, Arya SK, Raj A, Handa U. Changes in ocular surface status after phacoemulsification in patients with senile cataract. Int Ophthalmol. 2019 Jun;39(6):1345-1353. doi: 10.1007/s10792-018-0953-8. Epub 2018 Jun 20. |
| 24265705 | Background | Kasetsuwan N, Satitpitakul V, Changul T, Jariyakosol S. Incidence and pattern of dry eye after cataract surgery. PLoS One. 2013 Nov 12;8(11):e78657. doi: 10.1371/journal.pone.0078657. eCollection 2013. |
| 29677365 | Background | Micera A, Di Zazzo A, Esposito G, Longo R, Foulsham W, Sacco R, Sgrulletta R, Bonini S. Age-Related Changes to Human Tear Composition. Invest Ophthalmol Vis Sci. 2018 Apr 1;59(5):2024-2031. doi: 10.1167/iovs.17-23358. |
| 30515814 | Background | Di Zazzo A, Micera A, De Piano M, Cortes M, Bonini S. Tears and ocular surface disorders: Usefulness of biomarkers. J Cell Physiol. 2019 Jul;234(7):9982-9993. doi: 10.1002/jcp.27895. Epub 2018 Dec 4. |
| 29849499 | Background | Olivieri F, Prattichizzo F, Grillari J, Balistreri CR. Cellular Senescence and Inflammaging in Age-Related Diseases. Mediators Inflamm. 2018 Apr 17;2018:9076485. doi: 10.1155/2018/9076485. eCollection 2018. No abstract available. |
| 30156909 | Background | Baker JR, Vuppusetty C, Colley T, Hassibi S, Fenwick PS, Donnelly LE, Ito K, Barnes PJ. MicroRNA-570 is a novel regulator of cellular senescence and inflammaging. FASEB J. 2019 Feb;33(2):1605-1616. doi: 10.1096/fj.201800965R. Epub 2018 Aug 29. |
| 29259496 | Background | Ventura MT, Casciaro M, Gangemi S, Buquicchio R. Immunosenescence in aging: between immune cells depletion and cytokines up-regulation. Clin Mol Allergy. 2017 Dec 14;15:21. doi: 10.1186/s12948-017-0077-0. eCollection 2017. |
| 25325897 | Background | Torricelli AA, Santhiago MR, Wilson SE. Topical cyclosporine a treatment in corneal refractive surgery and patients with dry eye. J Refract Surg. 2014 Aug;30(8):558-64. doi: 10.3928/1081597X-20140711-09. |
| 31022299 | Background | Di Zazzo A, Micera A, Coassin M, Varacalli G, Foulsham W, De Piano M, Bonini S. InflammAging at Ocular Surface: Clinical and Biomolecular Analyses in Healthy Volunteers. Invest Ophthalmol Vis Sci. 2019 Apr 1;60(5):1769-1775. doi: 10.1167/iovs.18-25822. |