Chloroprocaine 3% Gel as a Novel Ocular Topical Anesthetic: Results from a Multicenter, Randomized Clinical Trial in Patients Undergoing Cataract Surgery.

Purpose: To compare the efficacy and safety of a novel ophthalmic anesthetic, chloroprocaine 3% gel to tetracaine 0.5% eye drops in patients undergoing cataract surgery with phacoemulsification. Methods: This was a prospective, randomized, multicenter, active-controlled, masked-observer, parallel group competitive equivalence study. The study comprised 338 patients having routine cataract extraction by clear corneal phacoemulsification, randomized to receive 3 drops of chloroprocaine gel (n = 166) or tetracaine eye drops (n = 172) before surgery. The primary objective of the study was to assess the equivalence of chloroprocaine gel to tetracaine eye drops as proportion of patients with successful ocular surface anesthesia, without any supplementation just before intraocular lens implantation. Safety measurements were pain, irritation, burning, stinging, photophobia, and foreign body sensation, graded by the patient and objective ocular signs. Results: Equivalence was demonstrated, with a somewhat higher success rate of chloroprocaine gel: 152/166 (92.0%) chloroprocaine versus 153/172 (90.5%) tetracaine patients achieved ocular surface anesthesia with no supplementation. Difference in proportions was 1.5% confidence interval [95% CI: (-3.6 to 6.6)] and 90% CI fell within (-10 to 10). Mean onset of anesthesia was 1.35 ± 0.87 min for chloroprocaine and 1.57 ± 1.85 for tetracaine (P = 0.083). Mean duration of anesthesia was 21.57 ± 12.26 min for chloroprocaine and 22.04 ± 12.58 for tetracaine (P = 0.574). No treatment emergent adverse events related to chloroprocaine were reported and no relevant findings related to local tolerance or vital signs were observed in both arms. Conclusions: Results obtained from the present cataract study demonstrated that chloroprocaine 3% ophthalmic gel is safe and effective, representing a valid alternative in ocular topical anesthesia. Clinical Trial Registration number: NCT04685538.

Latest evidences on meibomian gland dysfunction diagnosis and management.

Meibomian gland dysfunction (MGD) can be considered the leading cause of dry eye disease (DED) and one of the most common ophthalmic disorders found in clinical practice. The growing body of literature provides a substantial amount of information on this condition, but more efforts are needed to better interpret research data and to properly apply them to daily clinical practice., In this article, we reviewed the most recent publications on MGD diagnosis and management, focusing on the highest available level of evidence, provided by well-designed and well-reported studies on humans., Latest evidences on MGD diagnosis are mainly focused on imaging techniques, including meibography, optical coherence tomography (OCT), and in vivo confocal microscopy. Meibographic parameters, such as drop-out and glands' distortion, show great diagnostic accuracy, which accounts for their widespread use in clinical practice and research., Recent randomized controlled clinical trials on MGD treatment provided data on the role of antibiotics, steroids, essential fatty acids, intraductal meibomian gland probing, electronic heating devices and intense pulsed light therapy.

Evaluation of a novel eyelid-warming device in meibomian gland dysfunction unresponsive to traditional warm compress treatment: an in vivo confocal study.

The purpose of the study was to evaluate the efficacy and safety of wet chamber warming goggles (Blephasteam(®)) in patients with meibomian gland dysfunction (MGD) unresponsive to warm compress treatment. We consecutively enrolled 50 adult patients with low-delivery, non-cicatricial, MGD, and we instructed them to apply warm compresses twice a day for 10 min for 3 weeks and to use Blephasteam(®) (Laboratoires Thea, Clermont-Ferrand, France) twice a day for 10 min for the following 3 weeks. We considered "not-responders" to warm compress treatment the patients who showed no clinically significant Ocular Surface Disease Index (OSDI) improvement after the first 3 weeks. Clinical and in vivo confocal outcome measures were assessed in the worst eye (lower BUT) at baseline, after 3 weeks, and after 6 weeks. Eighteen/50 patients were not-responders to warm compress treatment. These patients, after 3 weeks of treatment with Blephasteam(®), showed significant improvement of OSDI score (36.4 ± 15.8 vs 20.2 ± 12.4; P < 0.05, paired samples t test), increased BUT (3.4 ± 1.6 vs 7.6 ± 2.7; P < 0.05), and decreased acinar diameter and area (98.4 ± 18.6 vs 64.5 ± 14.4 and 8,037 ± 1,411 vs 5,532 ± 1,172, respectively; P < 0.05). Neither warm compresses nor Blephasteam(®) determined adverse responses. In conclusion, eyelid warming is the mainstay of the clinical treatment of MGD and its poor results may be often due to lack of compliance and standardization. Blephasteam(®) wet chamber warming goggles are a promising alternative to classical warm compress treatment, potentially able to improve the effectiveness of the "warming approach."

Abnormal fundus autofluorescence results of patients in long-term treatment with deferoxamine.

PURPOSE: To describe and classify patterns of abnormal fundus autofluorescence (FAF) of patients with ß-thalassemia receiving long-term treatment with deferoxamine (DFO). DESIGN: Prospective, cross-sectional, case-control study. PARTICIPANTS: A total of 197 consecutive patients with ß-thalassemia major or intermedia with at least 10 years of treatment with DFO were recruited in a tertiary referral center in Milan, Italy, and were investigated. Seventy-nine thalassemic patients without a history of chelation therapy were included as a control group. METHODS: All of the patients were investigated using best-corrected visual acuity (BCVA), fundus photography, and FAF imaging by confocal scanning laser ophthalmoscopy (cSLO) and were compared with the control group. MAIN OUTCOME MEASURES: Identification of abnormal FAF patterns in thalassemic patients treated with long-term DFO and their progression and relationship with visual function. RESULTS: Abnormal FAF not related to other diseases was observed in 18 of the 197 patients (9%) and was classified into 4 phenotypic patterns: minimal change, focal, patchy, and speckled. The abnormal increased or decreased FAF was bilateral in all the cases, and only in some cases did it correspond to funduscopically visible alterations. There were no FAF abnormalities in the control group. During the follow-up, progressive FAF changes related to retinal pigment epithelium (RPE) damage occurred in the patchy pattern, associated with decreasing BCVA. Patients with speckled and focal patterns showed limited or no changes in FAF during the follow-up. No changes in FAF were found in patients with a minimal change pattern. No treated patient with a normal baseline examination demonstrated FAF changes. Patients with patterns other than the minimal change showed significant BCVA deterioration (P<0.001). CONCLUSIONS: Various phenotypic patterns of abnormal FAF can be identified with cSLO imaging. Fundus autofluorescence is a helpful, fast, and noninvasive tool for monitoring the status of the macula in patients at risk of DFO toxicity. It may be useful in the decision to discontinue or switch the therapy in cases of particular high risk for disease progression. The progressive alteration of the RPE suggests an important role of pathologic RPE changes in the evolution of visual loss during long-term treatment with DFO.

A multicenter, double-blind, parallel group, placebo-controlled clinical study to examine the safety and efficacy of T-Clair SPHP700-3 in the management of mild to moderate dry eye in adults.

PURPOSE: To study the safety and efficacy of T-Clair SPHP700-3, a new over-the-counter preservative-free formulation, in the management of mild to moderate dry eye in adults. METHODS: Sixty adult patients with mild to moderate dry eye were consecutively recruited in 2 eye clinics and randomized into 2 groups: treatment and placebo. Signs and symptoms of dry eye were compared along 28 days of treatment. RESULTS: No adverse events were reported during the study. Symptoms and signs of dry eye showed significant differences between the 2 groups after 2 and 4 weeks of treatment. CONCLUSIONS: SPHP700-3 preservative-free formulation showed to be safe and effective in mild to moderate dry eye, improving tear film stability, ocular surface lubrification, and patients' symptomatology.