Effect of Preservative-Free Tafluprost on Keratocytes, Sub-Basal Nerves, and Endothelium: A Single-Blind One-Year Confocal Study on Naïve or Treated Glaucoma and Hypertensive Patients Versus a Control Group

Rossi, Gemma Caterina Maria; Blini, Mirella; Scudeller, Luigia; Ricciardelli, Gabriella; Depolo, Laura; Amisano, Alberto; Bossolesi, Laura; Pasinetti, Giulio Maria; Bianchi, Paolo Emilio

doi:10.1089/jop.2013.0069

Cited by 20 publications

(23 citation statements)

References 16 publications

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“…In contrast to our findings a recent paper didn’t observe significant changes in corneal parameters in naive patients after 12 months of Tafluprost therapy [ 22 ]. The difference in results may be due to the different IVCM employed and treatment duration; little is known on the time of occurrence of corneal changes after starting antiglaucomatous therapies; it may take the corneal alterations more than 12 months to occur.…”

Section: Discussioncontrasting

confidence: 99%

Long term safety and tolerability of Tafluprost 0.0015% vs Timolol 0.1% preservative-free in ocular hypertensive and in primary open-angle glaucoma patients: a cross sectional study

2017

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BackgroundThe effects of preservatives of antiglaucoma medications on corneal surface and tear function have been widely shown in literature; it’s not the same as regards the active compounds themselves. The purpose of our study was to compare Ocular Surface Disease (OSD) signs and symptoms of Tafluprost 0.0015% versus preservative free (PF) Timolol 0.1% eyedrops in ocular hypertensive (OH) and in primary open-angle glaucoma (POAG) patients.MethodsA cross-sectional study included patients in monotherapy for at least 36 months with Tafluprost 0.0015% (27) or PF Timolol 0.1% (24) and 20 healthy age and sex-matched volunteers. All subjects underwent clinical tests (Schirmer I and break-up time), in vivo confocal microscopy (IVCM) and were surveyed using Ocular Surface Disease Index (OSDI) and Glaucoma Symptoms Scale (GSS) questionnaires. The groups were compared with ANOVA, Kruskal-Wallis test, t-test, Mann-Whitney test and Bonferroni’s adjustment of p-values.ResultsNo significant differences were found in questionnaires scores, clinical tests, IVCM variables between therapy groups. Tafluprost 0.0015% group showed significantly higher OSDI score, basal epithelial cells density, stromal reflectivity, sub-basal nerves tortuosity (p = 0.0000, 0.037, 0.006, 0.0000) and less GSS score, number of sub-basal nerves (p = 0.0000, 0.037) than controls but similar clinical tests results (p > 0.05). PF Timolol group had significantly higher OSDI score, basal epithelial cells density, stromal reflectivity and sub-basal nerve tortuosity (p = 0.000, 0.014, 0.008, 0.002), less GSS score, BUT and number of sub-basal nerves (p = 0.0000, 0.026, 0.003) than controls.ConclusionsCompared to PF Timolol 0.1%, Tafluprost 0.0015% showed similar safety with regards to tear function and corneal status and a similar tolerability profile. Both therapy groups show some alterations in corneal microstructure but no side effects on tear function except for an increased tear instability in PF Timolol 0.1% group. Ophtalmologists should be aware that even PF formulations may lead to a mild ocular surface impairment.

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Section: Discussioncontrasting

confidence: 99%

Long term safety and tolerability of Tafluprost 0.0015% vs Timolol 0.1% preservative-free in ocular hypertensive and in primary open-angle glaucoma patients: a cross sectional study

2017

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“…183,233 Rossi et al confirmed the lessened side effects in corneal nerves of preservative-free antiglaucoma drops after 1 year of treatment, showing that previously treated patients had an improvement in number of corneal nerves and tortuosity and that naïve patients did not show significant changes with the preservative-free medication. 235 Villani et al 236 showed that in stable primary open-angle glaucoma patients without a history of DED, there are subclinical ocular surface changes due to antiglaucoma medications. Interestingly, they observed increased subbasal nerve length and tortuosity, as well as dendritic cell density, compared to controls.…”

Section: Correlation Of Corneal Nerve Alterations To Corneal Sensmentioning

confidence: 99%

In Vivo Confocal Microscopy of Corneal Nerves in Health and Disease

2017

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In vivo confocal microscopy (IVCM) is becoming an indispensable tool for studying corneal physiology and disease. Enabling the dissection of corneal architecture at a cellular level, this technique offers fast and noninvasive in vivo imaging of the cornea with images comparable to that of ex vivo histochemical techniques. Corneal nerves bear substantial relevance to clinicians and scientists alike, given their pivotal roles in regulation of corneal sensation, maintenance of epithelial integrity, and proliferation and promotion of wound healing. Thus, IVCM offers a unique method to study corneal nerve alterations in a myriad of conditions, such as ocular and systemic diseases and following corneal surgery, without altering the tissue microenvironment. Of particular interest has been the correlation of corneal subbasal nerves to their function, which has been studied in normal eyes, contact lens wearers, and patients with keratoconus, infectious keratitis, corneal dystrophies, and neurotrophic keratopathy. Longitudinal studies have applied IVCM to investigate the effects of corneal surgery on nerves, demonstrating their regenerative capacity. IVCM is increasingly important in the diagnosis and management of systemic conditions such as peripheral diabetic neuropathy and, more recently, in ocular diseases. In this review, we outline the principles and applications of IVCM in the study of corneal nerves in various ocular and systemic diseases.

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“…Our study confirmed the findings by Baratz et al [31] and Martone et al [32] by showing a decrease in nerve fiber density and an increase in tortuosity by confocal microscopy in the corneas of treated glaucomatous eyes compared with controls. A study conducted by Rossi et al [35] hypothesized that BAK-free formulations, as effective as preserved ones, should be preferred in order to eliminate BAK-linked ocular surface changes. They performed IVCM in 75 eyes using Confoscan 3 (Nidek Technologies) and showed that tafluprost had significantly improved all the confocal parameters in glaucomatous eyes.…”

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confidence: 99%

Assessment of Corneal Changes Associated with Topical Antiglaucoma Therapy Using in vivo Confocal Microscopy

et al. 2018

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Purpose: Ocular surface disease (OSD) is highly prevalent in eyes treated with chronic, topical antiglaucoma (A/G) therapy. The purpose of this study was to utilize in vivo confocal microscopy (IVCM) to evaluate the corneal morphology, including characteristics of corneal epithelial cells, presence of epithelial dendritic cells (DCs), and characteristics of subbasal nerve plexus, of eyes under topical A/G therapy versus normal eyes. Methods: Central corneal images were prospectively captured from 30 eyes of 16 patients under topical A/G therapy (>6 months) and 20 normal control eyes, using IVCM (HRT 3 RCM, Heidelberg, Germany). Demographic data were collected, as well as information on the types and duration of A/G therapy. In addition, OSD index (OSDI) score, tear film breakup time, Schirmer 1 test results, density of epithelial wing cells (WCs) and basal cells (BCs), subbasal nerve features (density, tortuosity, and reflectivity), and presence of DCs were all assessed and recorded by trained Doheny Image Reading Center graders. Results: IVCM findings of 30 glaucomatous eyes and 20 normal control eyes were analyzed. The mean OSDI score was 8.72 in controls and 32.06 in patients under A/G therapy (p = 0.002). Nerve fiber density, nerve fiber reflectivity, and BC density were all decreased in the A/G group (1,789.07 ± 785.70 μm/frame, 2.79 ± 0.83, 6,457.67 ± 692.55 cells/mm², respectively) as compared to controls (2,815.981 ± 563.77 μm/frame, 3.52 ± 0.50, 7,854.13 ± 1,073.69 cells/mm², respectively) (p < 0.05), whereas the decrease in WC density was statistically nonsignificant (p = 0.5). Nerve tortuosity and DC density were both significantly greater in the A/G eyes (3.00 ± 0.57, 71.24 ± 61.74 cells/mm², respectively) compared to controls (2.10 ± 0.42, 34.08 ± 11.70 cells/mm², respectively) (p < 0.05). Tear film breakup time and Schirmer 1 test results were significantly lower in the A/G group as compared to controls (p < 0.001). Conclusions: Using IVCM, our study identified significant microstructural alterations in the corneas of eyes treated with topical A/G therapy. In addition, our study also revealed that glaucoma patients treated with topical A/G therapy report significantly higher OSDI scores compared to controls. Thus, IVCM may be a useful tool in providing structural parameters to correlate with the functional OSDI assessments in the evaluation of ocular surface toxicity associated with topical A/G therapy.

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Effect of Preservative-Free Tafluprost on Keratocytes, Sub-Basal Nerves, and Endothelium: A Single-Blind One-Year Confocal Study on Naïve or Treated Glaucoma and Hypertensive Patients Versus a Control Group

Cited by 20 publications

References 16 publications

Long term safety and tolerability of Tafluprost 0.0015% vs Timolol 0.1% preservative-free in ocular hypertensive and in primary open-angle glaucoma patients: a cross sectional study

Long term safety and tolerability of Tafluprost 0.0015% vs Timolol 0.1% preservative-free in ocular hypertensive and in primary open-angle glaucoma patients: a cross sectional study

In Vivo Confocal Microscopy of Corneal Nerves in Health and Disease

Assessment of Corneal Changes Associated with Topical Antiglaucoma Therapy Using in vivo Confocal Microscopy

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