Moderate Dry Eye Disease Research Articles

Dry Eye Disease after Refractive Surgery: Comparative Outcomes of Small Incision Lenticule Extraction versus LASIK

To compare small incision lenticule extraction (SMILE) versus LASIK for post-refractive dry eye disease. Prospective, comparative, nonrandomized clinical study. Thirty patients scheduled for bilateral myopic SMILE and 30 age-, sex-, and refraction-matched patients scheduled for bilateral myopic LASIK were enrolled and followed for 6 months after the surgery. Complete evaluation of dry eye disease was performed at 1 and 6 months postoperatively, which included vision-related quality of life (Ocular Surface Disease Index [OSDI]), clinical examinations (tear film breakup time [TBUT], Schirmer I test, corneal staining), and tear osmolarity measurements, together with an overall severity score. Function and morphology of the corneal innervation were evaluated by corneal esthesiometry and subbasal nerve imaging using in vivo confocal microscopy (IVCM). Overall analysis of dry eye disease and corneal innervation. High incidence of mild to moderate dry eye disease was observed in both groups 1 month postoperatively, which remained significantly higher in the LASIK group than in the SMILE group 6 months after surgery (overall severity score [0-4]: 1.2±1.1 vs. 0.2±0.4, respectively, P < 0.01), leading to more frequent use of tear substitutes over the long term. Corneal sensitivity was better in SMILE than in LASIK eyes 1 month postoperatively (3.5±1.79 vs. 2.45±2.48, respectively, P < 0.01) and then recovered to statistically similar values at 6 months. Corneal nerve density, number of long fibers, and branchings as assessed by IVCM were significantly higher in the SMILE group compared with the LASIK group 1 and 6 months after surgery. Corneal sensitivity was negatively correlated with dry eye-related corneal damage (R² = 0.48, P < 0.01), and the long fiber nerve density was independently correlated with the OSDI score (R² = 0.50, P < 0.01) and the Schirmer test (R² = 0.21, P < 0.01) 6 months postoperatively. The SMILE procedure has a less pronounced impact on the ocular surface and corneal innervation compared with LASIK, further reducing the incidence of dry eye disease and subsequent degradation in quality of life after refractive surgery.

Ocular tolerability and efficacy of a cationic emulsion in patients with mild to moderate dry eye disease – A randomised comparative study

The purpose of this study was to compare the safety and efficacy of a new cationic emulsion (CE) with a formulation of polyvinyl alcohol and povidone (PVA-P) for the treatment of mild to moderate dry eye disease. This was a multicenter, open-label, comparative study. Patients were randomised to receive CE (Cationorm) or PVA-P (Refresh) (1:1). The following objective criteria were assessed to compare the two eye drops: tear Break-up Time (TBUT), Schirmer's test, lissamine green staining (Van Bijsterveld score), corneal fluorescein staining (Oxford scale) and oculopalpebral examination, on D7 and D28 (end of study). At these visits, ocular symptoms and safety were also assessed. Seventy-nine patients were randomised: CE: 44 patients; PVA-P: 35 patients. At D28, improvement was significantly better for TBUT [CE: 1.7 ± 2.4 s; PVA-P: 0.6 ± 1.8 s; P=0.015] and for the Van Bijsterveld score [CE: -1.4 ± 1.2; PVA-P: -0.9 ± 1.2; P=0.046] in the CE group. The same applied for the palpebral erythema score (P=0.023), overall efficacy assessed by the investigators (P<0.001), and symptoms not related to eye drop instillation (P=0.021). Improvement was observed from D7. No difference was observed between the two treatments with regard to ocular safety. These results suggest that in patients with mild to moderate dry eye, Cationorm, in addition to its moisturizing and lubricating properties, also helps stabilize the tear film due to its oily component. This study demonstrates the benefit of this new pharmaceutical form for the treatment of mild to moderate dry eye disease.

Clinical efficacy of 0.1% pranoprofen in treatment of dry eye patients: a multicenter, randomized, controlled clinical trial

Background Dry eye is a multifactorial disease of the tears and the ocular surface. This study aimed to investigate the clinical efficacy of a non-steroidal anti-inflammatory drug, pranoprofen, in the treatment of dry eye. Methods It is a prospective, multi-center, randomized, controlled, parallel group study. One hundred and fifteen patients with mild to moderate dry eye disease (55-60 in each treatment group) participated in this multi-center study. Patients were randomly administered with eyedrops containing 0.1% pranoprofen (PRA) plus 0.1% sodium hyaluronate (SH) or SH only, three times daily for 28 days, followed by a 1-week after treatment observation. Dry eye symptom score (DESS), fluorescein corneal staining (FLCS), tear break-up time (TBUT), and Shirmer 1 tear test (ST1, without anesthesia) were evaluated or conducted before treatment and at each study visit. Conjunctival impression cytology was taken from the patients treated with PRA plus SH before and after treatment and real-time polymerase chain reaction (RT-PCR) was performed to detect the changes of human leukocyte antigen DR (HLA-DR) and intercellular adhesion molecule 1 (ICAM-1). Results Patients treated with PRA plus SH showed gradual improvements of DESS, FLCS, and TBUT. Between-group comparisons of FLCS and TBUT have statistically significant differences from day 14. Good tolerance with no severe adverse events was found in both groups. Patients treated with PRA plus SH had a reduced expression level of HLA-DR and were statistically different after 28 days of therapy. Conclusions The application of PRA at a dose of 0.1% was well tolerated and benefited to the patients with mild to moderate dry eye disease. The underlying mechanism of its efficacy may be associated with the reduction of inflammatory factors of conjunctival epithelial cells.

The Effect of an Artificial Tear Combining Hyaluronic Acid and Tamarind Seeds Polysaccharide in Patients with Moderate Dry Eye Syndrome: A New Treatment for Dry Eye

Synergistic interactions between hyaluronic acid (HA) and tamarind seed polysaccharide (TS-polysaccharide) have been demonstrated by means of nuclear magnetic resonance spectroscopy. This study was designed to investigate the potential clinical benefit of a combination of HA and TS-polysaccharide in managing dry eye disease (DED). A total of 49 subjects with moderate DED, confirmed by Ocular Surface Disease Index (OSDI) questionnaire score between 10 and 25, tear break-up time (BUT) <10 seconds, or Schirmer I test <5.5 mm after 5 minutes, and lissamine green staining of the ocular surface >2 according to National Eye Institute score system, were enrolled into this multicenter, randomized, double-masked study to receive either combination of HA and TS-polysaccharide or carmellose sodium for 3 months, both instilled 4 times per day. The assessments included OSDI questionnaire, tear film stability (BUT), tear production (Schirmer I test), and corneal and conjunctival staining. Patients treated with HA and TS-polysaccharide showed a statistically significant improvement in the OSDI score at the end of the study compared to the baseline and control groups. The HA and TS-polysaccharide and carmellose sodium were equally effective in reducing BUT and the extent of injury assessed by corneal and conjunctival staining. Non-significant changes were recorded for Schirmer I test. Based on the results of this clinical trial, the combination of HA and TS-polysaccharide appears to be effective in improving the symptoms of dry eye, opening new scenarios in possible treatment of the disease by combining different molecules.

A Novel Fluorescent Lipid Probe for Dry Eye: Retrieval by Tear Lipocalin in Humans

A fluorescent probe was used to identify mucin-depleted areas on the ocular surface and to test the hypothesis that tear lipocalin retrieves lipids from the eyes of normal and dry eye subjects. Fluorescein-labeled octadecyl ester, FODE, was characterized by mass spectrometry and absorbance spectrophotometry. The use of FODE to define mucin defects was studied with impression membranes under conditions that selectively deplete mucin. The kinetics of FODE removal from the ocular surface were analyzed by sampling tears from control and dry eye patients at various times. The tear protein-FODE complexes were isolated by gel filtration and ion exchange chromatographies, monitored with absorption and fluorescent spectroscopies, and analyzed by gel electrophoresis. Immunoprecipitation verified FODE complexed to tear lipocalin in tears. FODE exhibits an isosbestic point at 473 nm, pKa of 7.5, and red shift relative to fluorescein. The low solubility of FODE in buffer is enhanced with 1% Tween 80 and ethanol. FODE adheres to the ocular surface of dry eye patients. FODE produces visible staining at the contact sites of membranes, which correlates with removal of mucin. Despite the fact that tear lipocalin is reduced in dry eye patients, FODE removal follows similar rapid exponential decay functions for all subjects. FODE is bound to tear lipocalin in tears. Tear lipocalin retrieves lipid rapidly from the human ocular surface in mild to moderate dry eye disease and controls. With improvements in solubility, FODE may have potential as a fluorescent probe to identify mucin-depleted areas.

Assessment of the efficacy of Cationorm® in patients with moderate dry eye compared with Optive® and Emustil® eye drops

AbstractPurpose Dry eye disease (DED), the result of an insufficient tear film, is manifest by symptoms of ocular discomfort and ocular surface damage. An ideal DED therapy would regenerate each deficient tear film layer. Cationorm®, a preservative‐free cationic emulsion, augments the aqueous‐mucous and lipid layers of the tear film and reduces evaporation. The efficacy of Cationorm® was evaluated.Methods Adults with moderate DED defined by at least 1 symptom &gt;3 cm on a visual analog scale (VAS) and total corneal fluorescein score ≥3 and tear film break up time (BUT) &lt;7 seconds were enrolled in a 3 month, controlled, randomized, single‐masked study. Randomization to qid treatment with Cationorm® (Novagali), Optive® (Allergan) or Emustil® (SIFI) followed a washout period. Efficacy assessments were evaluated at 1 and 3 months.Results Of 71 patients, 8 (44%) Emustil treated patients discontinued prior to month 3. At month 1, the VAS score in Optive® and Cationorm® patients revealed a statistically significant improvement evident by month 3 for all treatments. Improvements in BUT and reduced fluorescein staining at month 3 were statistically significant for Cationorm® and Optive® but not Emustil®. While Cationorm® and Optive® significantly reduced tear film osmolarity only Cationorm® showed a statistically significant difference compared to Emustil®.Conclusion In moderate DED patients, Cationorm® was more effective than Emustil®. Although not statistically different, overall improvements were greater in patients treated with Cationorm® than Optive®.

Efficacy of Sodium Hyaluronate and Carboxymethylcellulose in Treating Mild to Moderate Dry Eye Disease

We compared the efficacy and safety of sodium hyaluronate (SH) and carboxymethylcellulose (CMC) in treating mild to moderate dry eye. Sixty-seven patients with mild to moderate dry eye were enrolled in this prospective, randomized, blinded study. They were treated 6 times a day with preservative-free unit dose formula eyedrops containing 0.1% SH or 0.5% CMC for 8 weeks. Corneal and conjunctival staining with fluorescein, tear film breakup time, subjective symptoms, and adverse reactions were assessed at baseline, 4 weeks, and 8 weeks after treatment initiation. Thirty-two patients were randomly assigned to the SH group and 33 were randomly assigned to the CMC group. Both the SH and CMC groups showed statistically significant improvements in corneal and conjunctival staining sum scores, tear film breakup time, and dry eye symptom score at 4 and 8 weeks after treatment initiation. However, there were no statistically significant differences in any of the indices between the 2 treatment groups. There were no significant adverse reactions observed during follow-up. The efficacies of SH and CMC were equivalent in treating mild to moderate dry eye. SH and CMC preservative-free artificial tear formulations appropriately manage dry eye sign and symptoms and show safety and efficacy when frequently administered in a unit dose formula.

Dry eye disease secondary to bacterial, fungal or acanthamoeba keratitis

Abstract Purpose To characterize dry eye disease after severe unilateral infectious (non‐viral) keratitis. Methods Tear break‐up time (BUT), Schirmer I test, Ocular surface disease index (OSDI) and Tear film osmolarity by means of Tearlab* (Tearlab, San Diego, CA, USA) were collected in patients admitted for severe unilateral non‐viral infectious keratitis in Ophthalmology departments of Strasbourg and Paris‐Bicetre university hospitals (France) between January and May 2010. All of these data were collected in both eyes (infected eye and non‐infected controlateral eye as a control) at least 3 month after the beginning corneal infection and 1 month after the end of topical treatment. Severity of infection was defined as a large (&gt; 2 mm) and/or a deep corneal infiltrates (&gt; 50% thickness). Results 21 patients (9 men, 12 women) were followed during the study. Mean age was 37 year‐old (range 19‐64). Bacteria, fungi and acanthamoeba were involved as pathogenic agents in 16, 3 and 2 cases respectively. The mean score of OSDI was 5.94+/‐3.83 in infected eyes and 2.17+/‐2.28 in control (non‐infected) eyes (p=0.0017). Tear osmolarity as 290.67+/‐7.56 mOsm/L in infected eyes as compared to 300.71+/‐6.40 in control eyes whereas tear BUT and Schirmer test were also significantly decreased in infected eye (p&lt;0.001 p=0.0023 and 0.0011 respectively). Conclusion Secondary dry eye disease is a common finding after severe corneal infection. However, decreased tear film osmolarity has been observed in all patients. These results are in contradiction with increased tear osmolarity reported in primary mild to moderate dry eye disease. Prolonged inflammation and subsequent destruction of resident cells of the conjunctiva and lacrimal glands could be hypothetized.

Ophthalmologist Perceptions Regarding Treatment of Moderate-to-Severe Dry Eye: Results of a Physician Survey

To understand ophthalmologists' current perceptions and treatment of patients with moderate-to-severe dry eye disease (DED). Online survey. The online survey was sent to 7,882 ophthalmologists, including 51 corneal specialists, throughout the United States from October 9 to 21, 2008. The response rate was 3.1% (n = 245), typical for this type of survey. Only ophthalmologists who treated four or more moderate-to-severe DED patients per month (235 of 245 [96%]) were asked to complete the survey. Ninety-four percent of respondents agreed that more treatment options are needed for moderate-to-severe DED. Corneal specialists were more likely to strongly agree (63%) than general ophthalmologists (54%). Only 33% overall felt that current therapies were extremely or very effective for moderate DED and only 5% for severe disease. Ninety-two percent agreed that multiple therapeutic agents are needed to manage moderate-to-severe DED. The respondents prescribed or recommended a mean of 3.2 different treatments (standard deviation = 1.2) for moderate DED patients over the course of a year and 4.9 (standard deviation = 2.2) for patients with severe DED. The most highly ranked goals for treatment of moderate-to-severe DED patients were maintaining and protecting the ocular surface (ranked 1 or 2 x 74%) and lubricating and hydrating the ocular surface (ranked 1 or 2 x 67%). Corneal specialists ranked maintaining and protecting the ocular surface even more highly (ranked 1 or 2 x 82%). Results reflected the difficulty of treating moderate-to-severe DED, the importance of using multiple treatment approaches, the limitations of current treatment options, and the need for additional treatment options.

Evaluation of Topical Cyclosporine for the Treatment of Dry Eye Disease

To evaluate the use of topical cyclosporine, 0.05% (Restasis; Allergan Inc, Irvine, California), for the treatment of mild, moderate, and severe dry eye disease unresponsive to artificial tears therapy. This was a prospective clinical study. One hundred fifty-eight consecutive patients with dry eye disease unresponsive to artificial tears therapy were divided into 3 groups of disease severity: mild, moderate, and severe. Patients were evaluated using the Ocular Surface Disease Index for symptomatic improvement, tear breakup time, fluorescein staining, lissamine green staining, and Schirmer testing. Patients were observed for 3 to 16 months. The main outcome measure was improvement in disease. Forty-six of 62 patients with mild dry eye disease (74.1%), 50 of 69 with moderate disease (72.4%), and 18 of 27 with severe disease (66.7%) showed improvement, with 72.1% improving overall. Topical cyclosporine shows beneficial effects in all categories of dry eye disease. Symptomatic improvement was greatest in the mild group and the best results in improvement of disease signs were in patients with severe dry eye disease.

Non-contact Confocal Microscopy of the Tear Film in Unoperated Eyes

The NIDEK ConfoScan4 (CS4) is a digital scanning slit confocal microscope. The corneal structure and tear film can be viewed, magnified, measured, and photographed at magnifications up to 500x, in vivo, in a noninvasive manner. The objective of this study was to evaluate and illustrate various conditions related to dry eye using the CS4 confocal microscope with the 20x noncontact lens. The CS4 was used to evaluate the natural tear film in 58 eyes of 29 patients with normal examinations, allergic conjunctivitis, nonspecific conjunctivitis, and dry eyes. In a subset of this patient population, subjective and objective findings were used to classify mild, moderate, and severe dry eye disease states. The usefulness of confocal microscopy as an objective tool to diagnose and manage different tear film-related ocular disease was also evaluated. The differences in tear film composition were visible using confocal microscopy. Photographs demonstrate confocal noncontact 20x microscopy as a diagnostic tool. Noncontact confocal microscopy is a valuable tool in the diagnosis and treatment of dry eye syndrome and other ocular states such as allergic and nonspecific conjunctivitis. It provides a simple and effective way to observe, classify, and treat the tear film. As investigators visualize and learn more, understanding of this structure will continue to improve.