Five-year results of iontophoresis-assisted transepithelial corneal cross-linking for keratoconus.

PURPOSE: To assess long-term efficacy and safety of iontophoresis-assisted transepithelial corneal cross-linking (I-CXL) for keratoconus. PATIENTS AND METHODS: Twenty-seven eyes of 21 patients (15 M, 6F) affected by progressive keratoconus were evaluated. All subjects were treated with iontophoresis-assisted transepithelial CXL. The patients were examined at baseline and each 6 months after the CXL procedure. Only subjects who completed the follow-up of 5 years were considered in this study. The main outcome measures were uncorrected visual acuity (UCVA), corrected visual acuity (CDVA), corneal transparency and corneal parameters such as K-max, central corneal thickness (CCT) and at the thinnest point, and high-order ocular aberrations (HOAs). The ABCD system was used to determine the progression and re-progression of ectasia. SETTING: Ophthalmology Clinic, University Hospital of Messina, Messina, Italy. RESULTS: At 5 years, significant improvements of UCVA from 0.53 ± 0.33 logMAR to 0.4 ± 0.33 logMAR (p = 0.001) and HOAs (p = 0.01) were registered. No significant changes of CDVA (p = 0.4), K-max (p = 0.75), CCT (p = 0.5) were observed at the end of follow-up period. The ABCD system showed re-progression in 25.9% of eyes after 5 years. No adverse events such as corneal opacities and infections were reported. CONCLUSIONS: Iontophoresis-assisted transepithelial CXL resulted to be safe and effective to stabilize progressive keratoconus in adults at a long-term follow-up.

Exploring the Healthy Eye Microbiota Niche in a Multicenter Study.

PURPOSE: This study aims to explore and characterize healthy eye microbiota. METHODS: Healthy subjects older than 18 years were selected for this descriptive cross-sectional study. Samples were collected with an eSwab with 1 mL of Liquid Amies Medium (Copan Brescia, Italy). Following DNA extraction, libraries preparation, and amplification, PCR products were purified and end-repaired for barcode ligation. Libraries were pooled to a final concentration of 26 pM. Template preparation was performed with Ion Chef according to Ion 510, Ion 520, and Ion 530 Kit-Chef protocol. Sequencing of the amplicon libraries was carried out on a 520 or 530 chip using the Ion Torrent S5 system (Thermo Fisher; Waltham, MA, USA). Raw reads were analyzed with GAIA (v 2.02). RESULTS: Healthy eye microbiota is a low-diversity microbiome. The vast majority of the 137 analyzed samples were highly enriched with Staphylococcus, whereas only in a few of them, other genera such as Bacillus, Pseudomonas, and Corynebacterium predominate. We found an average of 88 genera with an average Shannon index of 0.65. CONCLUSION: We identified nine different ECSTs. A better understanding of healthy eye microbiota has the potential to improve disease diagnosis and personalized regimens to promote health.

Use of Lacrimal Symptoms Questionnaire After Punctoplasty Surgery: Retrospective Data of Technical Strategy.

ABSTRACT: The goal of this study is to evaluate postpunctoplasty symptoms with lacrimal symptoms questionnaire (Lac-Q). A retrospective study was conducted on 31 patients (14 men and 17 woman) with a diagnosis of canalicular stenosis: 26 patients with unilateral occlusion and 5 patients with bilateral occlusion. The Lac-Q was administered preoperative and at 1, at 3, and at 6 months following the surgery. Moreover, the Lac-Q questionnaire was administered by an independent observer (SI). The mono-lateral and bilateral postoperative Lac-Q score showed a significant improvement of symptoms at 1, 3, and 6 months than the preoperative results. The Lac-Q questionnaire is a way to evaluate the quality of outcomes after punctoplasty surgery. In this study, all patients showed a significant improvement of symptoms after surgery.

Foveal avascular zone analysis by optical coherence tomography angiography in patients with type 1 and 2 diabetes and without clinical signs of diabetic retinopathy.

PURPOSE: To analyze the early macular microvascular alterations in patients with type 1 and 2 diabetes mellitus (DM) without diabetic retinopathy (DR), using optical coherence tomography angiography (OCT-A), and compare these with nondiabetic patients. METHODS: This prospective study involved 93 patients with type 1 diabetes (DM1), 104 patients with type 2 diabetes (DM2) without signs of DR, and 71 healthy subjects for the control group. The foveal avascular zone (FAZ) area and the vessel density (VD) at the superficial capillary plexus (SCP) and deep capillary plexus (DCP) were evaluated. RESULTS: The SCP and DCP FAZ areas were significantly larger in the DM1 group in comparison with the controls (p = .001), while no significant differences were observed between the DM2 group and the healthy control group (p = .12). Additionally, no significant differences in FAZ area were found between the DM1 and DM2 groups (p = .26). The VD was significantly reduced in DM1 and DM2 groups compared to controls. A direct correlation was found between the duration of diabetes and SCP FAZ area (r = 0.44; R2 = 0.19; p = .0001). Statistically significant differences in the FAZ area at SCP and DCP were observed when comparing patients with a diabetes duration > 10 years and < 10 years in the DM2 group (p = .0001, respectively) and only in the FAZ area at the DCP in the DM1 group (p = .0001). CONCLUSION: Diabetic patients without DR demonstrate early microvascular alteration in the macular area on OCT-A, which is more pronounced in type I DM, and correlates with the duration of the disease.

Rhino-Orbito-Cerebral Mucormycosis in Diabetic Disease Mucormycosis in Diabetic Disease.

The authors present their experience about clinical evidences that include patients with an untreated diabetes who developed rhino-orbito-cerebral mucormycosis (ROCM). They were treated with endoscopic sinus surgery and medical treatment with intravenous, intradural therapy, and sinus washes with amphotericin B. The ROCM is a disease with a rapid evolution and an increase in mortality rate, especially if the fungus enters the cranial cavity. Therefore, it would be necessary in all diabetic patients with sinus symptoms, headaches, visual changes, suspect a mucormycosis, and perform a careful radiology assessment and a nasal endoscopy. Often, despite an early diagnosis and rapid treatment for ROCM, it is not possible to stem the disease, which ends with the patient's death.

The Use of a Double Suture and Conjunctival Cuts in the Lateral Tarsal Strip: A New Approach to Involutional Ectropion.

PURPOSE: To describe the use of a double suture and conjunctival cuts in the lateral tarsal strip (LTS) and to evaluate postsurgical outcome in patients with severe involutional ectropion. METHODS: A prospective randomized study was conducted on 16 eyelids of 8 patients with symptomatic severe involutional ectropion. The 8 patients were between 62 and 79 years. They were distributed into 2 groups consisting of 4 patients each. The control group was treated with a conventional lateral tarsal strip (C-LTS), the second group underwent a modified lateral tarsal strip (M-LTS). The mean follow-up was 18 months. Success was defined as relief in lid laxity. The recurrence rate was also evaluated. RESULTS: Patients treated with M-LTS showed lower horizontal laxity (3.5 ±â€Š0.2) than patients treated with C-LTS (5.7 ±â€Š0.2). During the 18-month follow-up, a statistically significant difference was found between the 2 groups with P value <0.05. CONCLUSIONS: The use of a double suture and conjunctival cuts in the lateral tarsal strip proposed by Meduri showed a reduction of postsurgical ectropion's grade and postsurgical recurrences. This technique could be used for the treatment of patients with a severe ectropion.

Clinical Results of Accelerated Iontophoresis-Assisted Epithelium-on Corneal Cross-linking for Progressive Keratoconus in Children.

PURPOSE: To evaluate the clinical characteristics of pediatric patients with progression of keratoconus after accelerated iontophoresis-assisted epithelium-on corneal cross-linking (I-ON CXL) and to assess the efficacy and safety of re-treatment using accelerated epithelium-off CXL (epi-OFF CXL). METHODS: Sixteen eyes of 16 patients (mean age: 14.6 ± 2.5 years) with keratoconus underwent I-ON CXL. The main outcome measures were uncorrected distance visual acuity, corrected distance visual acuity, maximum keratometry index (Kmax), minimum corneal thickness, elevation front and elevation back measured at the thinnest point, total higher order aberrations root main square (HOA RMS), coma RMS, and spherical aberration. An increment of Kmax greater than 1.00 diopter (D) and a decrease of greater than 20 µm in pachymetry were considered to determine the progression of keratoconus. Patients with progression of keratoconus after I-ON CXL were re-treated using an epi-OFF CXL protocol. RESULTS: Two years after I-ON CXL, 12 patients showed progression of keratoconus, whereas 4 patients were stable. There was significant worsening of Kmax (P = .04) and steepest keratometric reading (P = .01). Furthermore, a significant correlation was documented between progression of keratoconus and age (P = .02). These patients were re-treated using an epi-OFF protocol and after 2 years all patients were stable, and a statistically significant reduction of the mean Kmax (P = .007), HOA RMS (P = .05), and coma RMS (P = 05) was observed. CONCLUSIONS: I-ON CXL was ineffective in the treatment of pediatric keratoconus in younger children, whereas it had an efficacy of 2 years in older children. Re-treatment using epi-OFF CXL proved effective to halt progression of keratoconus after I-ON CXL failure. [J Pediatr Ophthalmol Strabismus. 2024;61(1):44-50.].

Extensive Contact Lens Wear Modulates Expression of miRNA-320 and miRNA-423-5p in the Human Corneal Epithelium: Possible Biomarkers of Corneal Health and Environmental Impact.

The identification of new biomarkers of ocular diseases is nowadays of outmost importance both for early diagnosis and treatment. Epigenetics is a rapidly growing emerging area of research and its involvement in the pathophysiology of ocular disease and regulatory mechanisms is of undisputable importance for diagnostic purposes. Environmental changes may impact the ocular surface, and the knowledge of induced epigenetic changes might help to elucidate the mechanisms of ocular surface disorders. In this pilot study, we investigated the impact of extensive contact lens (CL) wearing on human corneal epithelium epigenetics. We performed ex vivo analysis of the expression of the miR-320 and miR-423-5p involved in the processes of cellular apoptosis and chronic inflammation. The human corneal epithelium was harvested from healthy patients before the photorefractive keratectomy (PRK). The patients were divided into two age- and sex-matched groups accordingly to CL wearing history with no CL wearers used as a control. The epithelium was stored frozen in dry ice at -80 °C and forwarded for miRNA extraction; afterwards, miRNA levels were detected using real-time PCR. Both miRNAs were highly expressed in CL wearers (p < 0.001), suggesting epigenetic modifications occurring in chronic ocular surface stress. These preliminary results show the relationships between selected miRNA expression and the chronic ocular surface stress associated with extensive CL use. MicroRNAs might be considered as biomarkers for the diagnosis of ocular surface conditions and the impact of environmental factors on ocular surface epigenetic. Furthermore, they might be considered as new therapeutic targets in ocular surface diseases.

The Use of Venous Catheter and Irrigation with Povidone-Iodine 0.6% in Patients with Punctal and Proximal Canalicular Stenosis: Preliminary Report.

Background: This study aimed to evaluate the safety and efficacy of povidone-iodine 0.6% (PVI) irrigation for preventing recurrence of stenosis after punctoplasty in patients with punctal and proximal canalicular stenosis treated using a venous catheter as a stent. Methods: Twenty patients were enrolled and divided into two groups. Group 1 received irrigation of 1 mL 0.6% PVI, while Group 2 received 1 mL of balanced salt solution (BSS). The patients underwent baseline, 15-, 30-, and 90-day assessments using the Ocular Surface Disease Index (OSDI) questionnaire, Symptoms Assessment in Dry Eye (SANDE), Schirmer I test, tear meniscus height (TMH), bulbar redness, meibography, and non-invasive breakup time (NIKBUT) through Keratograph 5M (Oculus, Germany). Results: At three months, both groups demonstrated statistically significant improvements in symptoms and ocular surface parameters. However, Group 1 showed statistically significant improvements in OSDI, SANDE scores, bulbar redness, and NIKBUT compared to Group 2. Additionally, no patients in Group 1 presented a recurrence of stenosis, while three patients in Group 2 demonstrated stenosis relapse at the end of the follow-up period. Conclusions: The application of a venous catheter and PVI 0.6% irrigations proved to be effective in treating proximal lacrimal duct stenosis, reducing the risk of recurrence and improving tear film stability, ocular discomfort symptoms, and ocular surface parameters.

Clinical and optical coherence tomography biomarkers as prognostic factors in dexamethasone intravitreal implant for diabetic macular edema.

PURPOSE: Aim of the study was to evaluate the efficacy of dexamethasone (DEX) 0.7 mg intravitreal implant in patients with diabetic macular edema (DME) and serous retinal detachment (SRD), and to study the prognostic factors on a follow up of 12 months. METHODS: Forty eyes of twenty- six patients with centre involving DME and SRD, who underwent DEX implant, were enrolled. Best-corrected visual acuity (BCVA), Swept source OCT imaging and intraocular pressure were evaluated. Central macular thickness (CMT), vitreomacular adhesion (VMA), disorganization of retinal inner layers (DRILs), hyperreflective dots (HRD), SRD and ellipsoid zone (EZ) disruption were included in the analysis at baseline and 12 months after implant. RESULTS: According to our parametric analysis, at 12 months, BVCA improvement from 48.6 ± 23.4 letters to 53.3 ± 24.5 letters was statistically significant (p = 0.04), CMT decreased from 460 ± 99.52 µm to 322.9 ± 117 µm. The presence at baseline of VMA (p = 0.01), EZ disruption (p = 0.03) and DRILs (p = 0.04), were associated with poor BCVA improvement at the end of follow-up. CONCLUSION: In conclusion, OCT biomarkers can be considered significant prognostic factors for treatment outcome in patients with DME undergoing DEX intravitreal implant.

Inner Retinal Thinning Comparison between Branch Retinal Artery Occlusion and Primary Open-Angle Glaucoma.

Purpose: to assess the tomographic retinal layers' thickness in eyes affected by branch retinal artery occlusion (BRAO) and to compare it to those of patients affected by primary open angle glaucoma (POAG). Methods: retrospective review of 27 patients; 16 with BRAO (16 eyes) and 11 with POAG (20 eyes) were identified among those who received SD-OCT scans, including analysis of macular retinal nerve fiber layer (mRNFL), ganglion cell layer (GCL), inner plexiform layer (IPL), inner nuclear layer (INL), neuroretinal rim (NRR), circumpapillary RNFL at 3.5 mm and hemisphere asymmetry (HA). Results: the total IPL and INL thinning difference between the two groups was statistically significant (p = 0.0067 and p < 0.0001, respectively). The HA difference for the total macular thinning, mRNFL, GCL, IPL and INL (p < 0.0001) was also statistically significant. The analysis of the average total retinal thinning, total mRNFL and GCL thinning showed no statistically significant difference between the two groups. Conclusions: unilateral inner retinal thinning may represent a sign of temporal BRAO, particularly for INL thinning and HA difference over 17µm in total retinal layer thinning. This information is particularly useful in the diagnosis of previous, undiagnosed BRAO and may help prevent further retinal arterial occlusion and possible cerebrovascular incidents.

Persistent severe visual field impairment is associated with obesity and tumour invasiveness, but not with pituitary dysfunction, in patients with craniopharyngioma.

PURPOSE: Craniopharyngiomas (CP) are benign tumours of the sellar region. Hypopituitarism, visual deficits, hypothalamic damage with consequent obesity and related increased cardiovascular risk, are complications due to the tumour itself or secondary to treatment strategy. We retrospectively correlated visual field status with clinical, neuroradiological, histopathological features and management strategy, in a single-centre cohort of patients with CP. METHODS: Thirty-four patients (16 M; median age 27.2 ± 21.8 yrs) with CP were included. We evaluated visual field status, assessed by means of standard automated perimetry and expressed as mean deviation (MD), at last follow-up visit (median 14 ± 11.7 yrs). MD has been correlated with clinical, radiological, histological data and treatment modalities. RESULTS: In univariate analysis worst eye MD was significantly associated with panhypopituitarism (p 0.010). In multivariable linear regression, panhypopituitarism (p 0.008), CP recurrence (p 0.020) and DI (p 0.004) were found to be the main independent predictors of a worse visual field outcome. When stratifying patients according to the degree of visual field impairment (MD < -12 dB Vs MD > -12 dB), the main independent predictors of worse visual field outcome were older age at diagnosis (p 0.010), CP histological subtype (p 0.004), invasiveness (p 0.04), CP recurrence (p 0.035), DI (p 0.002) and weight at last follow-up (p 0.012). CONCLUSION: In CP patients the long-term ophthalmological impairment is frequent, especially at older age, and strictly related to tumour invasiveness and recurrence, and associated to pituitary disfunction and obesity.

Combined intense pulsed light and low-level light therapy for the treatment of refractory Meibomian gland dysfunction.

PURPOSE: To evaluate the efficacy of combined Intense Pulsed Light (IPL) and Low-Level Light Therapy (LLLT) in treatment of Meibomian Gland Dysfunction (MGD). METHODS AND ANALYSIS: In this prospective study, 70 patients with refractory MGD were enrolled; group 1 received 3 consecutive sessions of IPL + LLLT treatment using Eye-light® on day 1, day 15 and day 45; group 2 received hyaluronate sodium 2 mg/ml drops 3 times a day for 6 months. Patients underwent at baseline, and after 3 and 6 months Ocular Surface Disease Index (OSDI) questionnaire, Symptom Assessment in Dry Eye (SANDE), tear-film breakup time (TBUT), fluorescein ocular surface staining, meibum expressibility and quality evaluations. Keratograph 5M (Oculus, Germany) was used to assess NIBUT, tear meniscus height (TMH), meibography, and bulbar redness score. RESULTS: At 6 months a significant improvement of OSDI (p = 0.03), SANDE (p = 0.02), NIBUT (p = p < 0.0001), TMH (p = 0.04), TBUT (p = 0.02), corneal-conjunctival staining score (p = 0.02), lid margin score (p < 0.0001), and bulbar redness score (p = 0.001) were recorded in group 1. Comparing the two groups, statistically significant differences were observed at 6 months in TBUT (p = 0.03), lid margin score (p < 0.001), Meibum expressibility (p = 0.03) and NIBUT (p < 0.001). No adverse events were recorded throughout the follow-up period. CONCLUSION: This study confirmed the efficacy and safety of combined IPL and LLLT demonstrating its superiority compared to topical treatment.

Coexisting Choroidal and Brain Metastases in a Patient with Breast Cancer Treated with Stereotactic Radiotherapy.

Choroidal metastases from breast cancer are the most common ocular malignancies in adults. We report a case of a 37-year-old female with a history of breast cancer who had a sudden blurred vision in her right eye. An ophthalmologic assessment revealed a dome-shaped lesion and a secondary retinal detachment with subretinal fluid in the left eye, suggestive of choroidal metastasis. Moreover, an MRI scan showed the presence of a single brain lesion. The patient was treated with stereotactic radiotherapy, with 300 cGy for 10 days. Six months after treatment, there was a regression of the mass and improvement of visual acuity. Stereotactic radiotherapy is a safe and effective treatment for choroidal metastases and should be considered to treat coexistent choroidal and brain metastatic lesions, to improve survival, visual function, and quality of life.

Double safe suture during cataract surgery on post radial keratotomy patients using clear corneal incisions.

PURPOSE: the aim of this study is to find a safer surgical approach in cataract surgery on eyes previously treated with radial keratotomy using clear corneal incisions. SETTING: Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Ophthalmology Clinic, University of Messina, Messina, Italy. DESIGN: Prospective study. METHODS: A prospective study was conducted on a group of 20 patients, 21 eyes with 16 RK incisions were evaluated for cataract phacoemulsification. Samples were divided into two groups: Group 1 underwent surgery with pre-operative one corneal stitch along radial keratotomy incisions near the main access site whereas Group 2 underwent modified surgery with two corneal stitches. RESULTS: After surgery, visual acuity, corneal hysteresis and corneal strength was evaluated. In all cases, an increased visual acuity was observed. Group 1 showed an UCVA of logMAR 0.22 ± 0.14, while group 2 presented a logMAR of 0.1 ± 0.07. Data did not show a statistically significant difference in UCVA after surgery between the two groups (P = 0.133). Instead, a significant difference in corneal hysteresis (CH), respectively with values of 8.65 ± 1.6 mmHg in group 1 and 9.2 ± 1.8 in group 2 (P = 0.031), and a corneal resistance factor (CRF) with values of 7.87 ± 1.4 mmHg in the first group and 8.65 ± 1.6 mmHg in the second one (P = 0.039) was observed. CONCLUSIONS: Double safe suture technique offers better stabilization of corneal structure during surgery in patients preventively treated with 16 incisions RK.

OCT Angiography Features in Diabetes Mellitus Type 1 and 2.

Purpose: To study the foveal avascular zone (FAZ) and the vessel densities (VD) in diabetic patients using optical coherence tomography angiography (OCT-A) and inner retinal layer changes to compare patients affected by type 1 diabetes (DM1) and type 2 diabetes (DM2). Methods: Cross-sectional observational study involving 150 eyes of 150 patients with DM1, and 155 eyes of 155 patients with DM2 with diabetic retinopathy (DR). Retinal nerve fiber layer (RNFL) and Ganglion cell layer (GCL) were evaluated. OCT-A studied both FAZ and VD at the level of the superficial capillary plexus (SCP) and the deep capillary plexus (DCP). Results: A statistically significant difference in FAZ area and foveal VD measured at the SCP (p < 0.001) was noted between DM1 and DM2 groups when comparing patients with mild and moderate non-proliferative diabetic retinopathy (NPDR), while no differences were found in the severe NPDR and proliferative diabetic retinopathy (PDR) subgroups. Duration of diabetes and stage of DR were directly correlated with enlargement of FAZ area and inversely correlated with foveal VD measured at SCP. RNFL and GCL were not different between DM1 and DM2 groups. Conclusion: Changes in OCT-A parameters detected in FAZ area and VD of diabetic patients with different stages of DR may help to predict the risk for progression of the disease.

Neurotrophic Keratopathy in Systemic Diseases: A Case Series on Patients Treated With rh-NGF.

Purpose: To evaluate the prevalence, clinical ocular presentation and corneal healing in moderate and severe neurotrophic keratopathy (NK) caused by systemic diseases and treated with rh-NGF. Setting: Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Ophthalmology Clinic, University of Messina, Italy. Design: Retrospective observational study of case series. Materials and Methods: In this retrospective observational study 11 patients (five female and six males) aged from 24 to 88 years (55.4 ± 21.3 years) with moderate and severe NK caused by systemic diseases were enrolled. The VAS questionnaire was dispensed. The ocular examination comprised slit lamp evaluation, ocular surface assessment with Keratograph 5M (Oculus, Germany), corneal sensitivity with Cochet-Bonnet esthesiometer (Lunneaux, France) and corneal thickness measurement with AC-OCT (DRI, Triton, Topcon, Japan). The underlying systemic causes of NK were determined. Results: The main cause of NK was post-neuroma surgery (36%), followed by diabetes (18%). The remaining causes were rheumatoid arthritis (9%), post-traumatic (9%), post-surgery (9%), atopia (9%), Graves' disease (9%). Seven eyes presented severe grade of NK with corneal ulcer and in four a moderate grade was registered. The rh-NGF (Cenegermin) was administered with a standard protocol one drop six times daily for 8 weeks. The complete healing of all corneal defects was registered at the end of the treatment. Conclusions: The post-neuroma surgery was the most common cause of NK and severe grade was clinically more represented. The rh-NGF proved effective to promote corneal recovery with all defects healed after the treatment.

Effects of the Topical Use of the Natural Antioxidant Alpha-Lipoic Acid on the Ocular Surface of Diabetic Patients with Dry Eye Symptoms.

PURPOSE: The purpose of this study is to investigate the effects of the treatment with eye-drops based on a combination of antioxidant and mucomimetic molecules, namely 0.1% alpha-lipoic acid (ALA) and 0.3% hydroxy-propyl-methylcellulose (HPMC) on the ocular surface of diabetic patients with dry eye symptoms. METHODS: Seventy patients, 42 M and 28 F, aged from 50 to79 years (mean 62.1 ± 10.5), affected by type II diabetes mellitus, were enrolled and divided in two groups treated for 2 months as follows: Group 1 (35 patients), received topical ALA/HPMC three times a day, Group 2 (35 patients) received topical HPMC (0.3%) alone, three times a day. The main outcome measures were: Ocular Surface Disease Index (OSDI), tear film break-up time (TBUT), corneal fluorescein staining, Schirmer I test, corneal sensitivity. An examination of tear film morphology with confocal microscopy was carried out in a subset of patients of each group at baseline and after two months. Statistical analysis was performed with t-test for the parametric data and Mann-Whitney U-test or chi-squared test for the nonparametric data. RESULTS: Both treatments resulted in significant improvements of BUT, OSDI and tear film morphology, although the improvements observed in group 1 showed a higher trend than what observed for group 2. Moreover, only in group 1 a significant improvement was visible for corneal staining, and no significant improvements were observed in any group for Schirmer I and sensitivity. CONCLUSIONS: These results confirmed the efficacy of HPMC in the treatment of diabetic dry eye and indicated that the addition of a strong self-regenerating antioxidant like ALA may give a distinctive advantage for the healing of corneal defects (as evidenced by corneal staining), beside improving HPMC efficacy on three other parameters (BUT, OSDI score, tear morphology). Therefore, the addition of a strong antioxidant like ALA can be helpful in preventing or treating ocular surface defects in diabetic patients, in which the oxidative damage is predominant.

Clinical Efficacy, Tolerability and Safety of a New Multiple-Action Eyedrop in Subjects with Moderate to Severe Dry Eye.

Background: To assess the clinical efficacy, tolerability and safety of a new-generation ophthalmic solution containing cross-linked hyaluronic acid 0.15% trehalose 3%, liposomes 1% and sterylamine 0.25% (Trimix® Off Health Italia, Firenze, Italy) (CXHAL) versus trehalose 3% (Thealoz®, Thea Pharmaceuticals, Clermont-Ferrand, France) (TRS) in subjects with moderate to severe dry eye disease (DED). Patients and methods: In this prospective, observational cohort study, 41 subjects with moderate to severe dry eye were enrolled and divided into two age- and sex-matched groups. Group 1 was treated with CXHA eye drops, and group 2 was treated with TRS eye drops four times daily for 2 months. All subjects were evaluated at baseline (V0) and at day 60 ± 3 (V1). The examination comprised Best Corrected Visual Acuity (BCVA) and Symptom Assessment in Dry Eye (SANDE). Tear osmolarity was evaluated using the TearLab Osmolarity System®; Keratograph 5M (Oculus, Wetzlar, Germany) was performed to assess tear meniscus height (TMH), fluorescein tear break-up time (TBUT) and corneal and conjunctival fluorescein staining and meibography; furthermore, slit lamp evaluation was performed for eyelid erythema and edema, conjunctival chemosis and hyperemia and Meibomian gland secretion quality. Results: All patients completed the treatment. BCVA remained stable in both groups, and no adverse events were reported. After 2 months, both groups showed statistically significant improvements for SANDE (p = 0.001 and p = 0.012, respectively), TBUT values (p < 0.001 and p < 0.001, respectively) and staining (p = 0.004 and p = 0.001, respectively) as compared to baseline values. Group 1 showed a statistically significant improvement in SANDE frequency and tear osmolarity (p = 0.02 and p = 0.001, respectively), whereas chemosis was significantly reduced in group 2. The amount of TBUT improvement was statistically higher in group 1 compared to that in group 2 (p = 0.041). Conclusion: A new-generation multiple-action ophthalmic solution was safe and clinically effective in the treatment of moderate and severe dry eye, with significant improvements in the main ocular surface parameters.

Safety and Tolerability of an Eye Drop Based on 0.6% Povidone-Iodine Nanoemulsion in Dry Eye Patients.

Purpose: To evaluate safety and tolerability on the ocular surface of an anti-septic formulation containing 0.6% povidone-iodine (0.6% PVI) for a 4 week period. Methods: An observational, prospective study included 20 mild-moderate dry eye disease (DED) patients who enrolled at the Ocular Surface Disease Unit of the University of Messina, receiving 0.6% PVI eye drops for 28 days, 2 drops twice daily (BID). The assessment included the Ocular Surface Disease Index questionnaire; symptoms score (0 = absent to 3 = severe) for burning, ocular dryness, foreign body sensation, watery eyes, tearing, photophobia, and ocular pain; fluorescein tear break-up time (TBUT); and corneal-conjunctival staining, performed at baseline (T0), after 7 (T7) and 28 (T28). Schirmer I-test, corneal endothelial cell count, intraocular pressure, and fundus examination were performed at T0 and T28. The main outcome measures were TBUT and corneal-conjunctival staining as markers of ocular surface homeostasis. For statistical analysis, Student's T-test and Wilcoxon test were used as appropriate. Results: No significant alterations of the safety parameters were found throughout the study. Further, at T28 a significant improvement of burning, ocular dryness, foreign body sensation, and watery eyes (T0 vs. T28 P < 0.03) were observed; corneal-conjunctival staining improved at T28 (T0 vs. T28 P < 0.0001), and TBUT improved already at T7 (T0 vs. T7 P = 0.0008) lasting so till the end of the study. The only adverse event was mild burning at instillation for the first 3 days of treatment in most of the patients. Conclusions: The treatment with 0.6% PVI was safe and well tolerated in a group of patients with a damaged ocular surface.