Intraocular Pressure: Intravitreal Preservative-free Triamcinolone Injection in Diabetic Macular Edema and Branch Retinal Vein Occlusion

PURPOSE: To compare the intraocular pressure (IOP) in diabetic macular edema (DME) patients and macular edema associated with branch retinal vein occlusion (BRVO) patients after intravitreal preservative-free Triamcinolone injection.METHODS: This study included 36 patients diagnosed with DME and 44 patients diagnosed with BRVO with macular edema. Both groups were treated with intravitreal preservative-free Triamcinolone (Maqaid®, Wakamoto Pharmaceutical Co., Ltd., Tokyo, Japan) injection, and we compared the IOPs of the two groups determined before injection and at 1, 2, 3, and 6 months after injection. We also compared the IOP elevation ratios and durations, and central foveal thickness (CFT) changes using optical coherence tomography.RESULTS: In both groups, there was no statistical significance in the IOP before injection and at 1, 2, 3, and 6 months after injection. However, the IOP elevation ratio in the DME patients (38.9%) was significantly higher than that in the BRVO patients (15.9%) (p = 0.02). The duration of IOP elevation in the DME patients (1.14 ± 1.85 months) was significantly longer than that in the BRVO patients (0.30 ± 1.20 months) (p = 0.03). When the IOP was not controlled, we used IOP-lowering agents, and two patients in the DME were treated with glaucoma surgery. There was no statistical significance in the CFT before injection and at 1, 2, or 3 months after injection between the two groups (p = 0.72, p = 0.26, p = 0.66, p = 0.34, respectively). However, the CFT after 6 months was 328 ± 103 µm in the DME group and 434 ± 189 µm in the BRVO; this difference was significant (p < 0.01).CONCLUSIONS: Intravitreal injection of preservative-free Triamcinolone was effective in the treatment of both DME patients and macular edema patients associated with BRVO. Furthermore, Triamcinolone was more safely injected in macular edema associated with BRVO patients than in DME patients.

Effects of Corneal Toxicity and Conjunctival Injection of Preservative-free 0.1% Fluorometholone after Pediatric Strabismus Surgery

PURPOSE: To compare the degrees of conjunctival injection and corneal toxicity between preservative and preservative-free topical 0.1% fluorometholone after strabismus surgery. METHODS: A randomized, prospective clinical study was performed to compare the degrees of conjunctival injection and corneal toxicity between preservative and preservative-free topical 0.1% fluorometholone after strabismus surgery. Sixty-one patients with intermittent exotropia were included in this study. They were told to apply antibiotic eye drops (ED) and either preservative or preservative-free topical 0.1% fluorometholone (F1) three times a day. Measurements of the degrees of conjunctival injection and corneal toxicity were performed at postoperative 1 week and 3 weeks each. RESULTS: Seventeen patients (34 eyes) were included in group 1 (preservative F1) and twenty patients (40 eyes) were included in group 2 (preservative-free F1). The average pixel value (measured via the Image J software) representing the degree of conjunctival injection was 31,732 ± 9,946 in group 1 and 38,347 ± 12,189 in group 2 at postoperative 1 week, while the average pixel value was 10,150 ± 4,493 in group 1 and 11,836 ± 4,290 in group 2 at postoperative 3 weeks. There was a significant difference between the decrease in pixel value for the two groups (p = 0.040). There was no significant difference in the mean value of the Oxford stain score between the two groups at postoperative 3 weeks, however the mean questionnaire scores in group 2 were significantly lower than in group 1 (p = 0.001). CONCLUSIONS: Preservative-free 0.1% fluorometholone ED demonstrated a larger decrease in the degree of conjunctival injection than for preservative ED after strabismus surgery. Therefore, the use of preservative-free steroid ED may be beneficial for decreasing both conjunctival injection and postoperative discomfort following strabismus surgery.

Effect of a Preservative-free Dorzolamide/Timolol Fixed Combination on Elevated Intraocular Pressure after Vitrectomy

PURPOSE: To verify the effect of preservative-free Dorzolamide/Timolol fixed combination (PFDTC) on intraocular pressure (IOP) elevation after vitrectomy. METHODS: We retrospectively reviewed medical records of 33 patients who used PFDTC after pars plana vitrectomy. All patients' visual acuity and IOP was measured and symptoms of conjunctival irritation were investigated through survey and slit lamp examination. RESULTS: Before vitrectomy, the mean IOP was 13.6 ± 4.4 mm Hg which was elevated to 31.7 ± 5.4 mm Hg after vitrectomy (p < 0.001) and applying eyedrop lowered the mean IOP to 17.2 ± 7.0 mm Hg (p < 0.001). Regardless of tamponade material type, all elevated IOP decreased (p < 0.001) and the IOP of all 33 eyes did not rise to over 30 mm Hg again. No additional surgery for IOP control was needed during two-month follow-up period. Of the 33 patients using PFDTC, patients who felt discomfort were five (15.2%) and no patients showed side effects severe enough to stop use of eyedrop. CONCLUSIONS: PFDTC is an anti-glaucomatic agent which can reduce the IOP by inhibiting aqueous humor production. Without need for additional surgery, the eyedrop can effectively lower elevated post-vitrectomy IOP, with expectation of good patient compliance due to low risk of conjunctival irritation.

Design and Development of Self-preserving and Preservative-free Herbal Liquid Oral Formulation.

Microbial contamination is one of the major inevitable concerns associated with herbal liquid formulations, which may originate from herbal raw materials. Inclusion of preservatives in herbal liquid formulations has been of considerable value for many years. Anti-microbial preservatives are normally added to prevent microbial proliferation while the product on shelf and during in use conditions. The properties of these preservatives are due to certain functional groups, which are usually harmful to living cells and might therefore be associated with certain risks when used in humans and they are the leading causes of adverse reactions and have negative and potentially life threatening side effects, because they not only act on microorganism but may also interfere with human cells. In this study, we have made an effort to develop a preservative-free and self-preserving liquid oral formulation by understanding and applying alternative principles of preservation (approaches other than using preservatives) by taking Ashoka herb extract as a prototype. Our series of formulation trials using different vehicle systems, which reduce the water activity by controlling the pH and osmotic conditions successfully yielded a vehicle system that could be used for the manufacturing of stable preservative-free/self-preserving herbal liquid oral formulations. Ashoka formulations were found to be physically, chemically and microbiologically stable during the six months of accelerated stability studies.

Preserved to preservative free prostaglandin analogues in primary open angle glaucoma.

Glaucoma affecting 60 million people all over the world and it will be 80 million till 2020. There are approximately 11.2 million persons aged 40 years and older with glaucoma in India. Primary open angle glaucoma (POAG) is commonest type, affecting 2/3rd of glaucoma patients. POAG is estimated to affect 6.48 million persons. The estimated number with primary angle-closure glaucoma is 2.54 million. POAG develops gradually and take long time to get detected and require long term treatment with topical prostaglandin analogues (PGF2) which is the most common as well as most widely used drugs. These PGF2 analogues need to be taken for longer time and more prone to develop adverse drug reactions. Common ADR seen with PG analogues are irritation on instillation, foreign body sensation, dryness of eyes, pain in eye, increased pigmentation of iris, increased eyelash growth, changes in periorbital sulcus and fat. Some ADRs (Adverse Drug Reaction) are explained by the inherent properties of Prostaglandins and those are not explained are because of preservative used in medication and these ADRs can be minimised by using preservative free drug like Tafluprost which are having same efficacy in decreasing IOP.

Effect of Preservative-free Artificial Eye Drop on Human Corneal Epithelial Cell in vitro

PURPOSE: To investigate the biologic effects of preservative-free artificial tear drops on cultured human corneal epithelial cells in vitro. METHODS: Efficacies of the preservative-free artificial tear drops-Kynex(R), Hyalein Mini 0.3%(R), and Refresh Plus(R)-were evaluated using the MTT assay. Cell damage was determined using the lactate dehydrogenase (LDH) assay. Cellular proliferation was determined using a migration and wound-healing assay. The ingredients of the drugs were analyzed. Apoptotic response was evaluated with flow cytometric analysis. RESULTS: Metabolic activity of the corneal epithelial cells showed similar activity to that of the control. Cellular migration and proliferation also were not significantly different between the preservative-free artificial tear drop groups and the control. The LDH titers tended to increase for up to 24 hours after exposure to the preservative-free artificial tear drops, but there was no significant difference in LDH titers between the control groups and the artificial tear drop-treated groups. Apoptosis and necrosis were observed using flow cytometry at 24 hours in all groups. The electrolyte levels, pHs and osmolarities of the three drugs were not significantly different. CONCLUSIONS: The clinically available preservative-free artificial tear drops Kynex(R), Hyalein Mini 0.3%(R), and Refresh Plus(R) had no significant toxic effects on corneal epithelial cells and thus can be used safely.