Efficacy and Safety of Sodium Hyaluronate/chondroitin Sulfate Preservative-free Ophthalmic Solution in the Treatment of Dry Eye: A Clinical Trial.

Purpose: To evaluate the efficacy of a preservative free sodium hyaluronate/chondroitin sulfate ophthalmic solution (SH/CS-PF) in patients with dry eye disease (DED).Methods: This was a randomized phase IV, multicentric, prospective, double-blind clinical trial. Intent-to-treat (ITT) and per-protocol (PP) analyses were performed. Patients were assigned to receive either SH/CS-PF, Systane® Ultra (PEG/PG) or Systane® Ultra PF (PEG/PG-PF) for 90 days. A total of 326 patients were included in the ITT, and 217 in the PP analysis. Efficacy endpoints were goblet cell density, Nelson's grades (conjunctival impression cytology), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), and Schirmer's test. Other parameters included were tolerability, measured by the ocular symptomatology; and safety, measured through corneal staining, intraocular pressure, visual acuity and adverse events.Results: In the ITT, there was a significant increase in mean goblet cell density in all treatments compared with their baseline (28.4% vs 21.4% and 30.8%), without difference between arms (p = .159). Eyes exposed to SH/CS-PF, PEG/PG and PEG/PG-PF showed Grade 0-I squamous metaplasia (85.5%, 87.9% and 93.2%, respectively). Similar improvements were observed for TBUT (1.24 ± 2.3s vs 1.27 ± 2.4s and 1.39 ± 2.3s) and OSDI scores at day 90 (-8.81 ± 8.6 vs -7.95 ± 9.2 and -8.78 ± 9.8), although no significant intergroup difference was found. Schirmer's test also presented improvement compared to baseline (1.38 ± 4.9 vs 1.50 ± 4.7 and 2.63 ± 5.9), with a significantly higher variation for PEG/PG-PF. There were no significant differences between treatments for any tolerability and safety parameter, nor between ITT and PP analyses for any outcome.Conclusions: The topical application of SH/CS-PF is as effective, safe and well tolerated as that of PEG/PG or PEG/PG-PF. The results suggest that SH/CS-PF may lead to normalization of clinical parameters and symptom alleviation in patients treated for DED.

Effects of Muller's muscle-conjunctival resection for ptosis on ocular surface scores and dry eye symptoms.

This article evaluates the effects of Muller's muscle-conjunctival resection (MMCR) on ocular surface scores and dry eye symptoms. Forty-six patients were enrolled in the study. Eighteen underwent bilateral upper eyelid skin excision with MMCR and 28 underwent bilateral upper eyelid skin-only excision (control group). The Salisbury Eye Evaluation Questionnaire and an ocular surface evaluation protocol consisting of Schirmer's test, tear break-up time (TBUT), fluorescein and rose bengal corneal staining were performed during the pre-operative consultation and on postoperative days 7, 30, and 90. Improvement in symptoms questionnaire scores from baseline was observed on postoperative day 90 in the blepharoplasty plus MMCR group. There was no change in questionnaire scores in patients who underwent blepharoplasty alone. No between-group difference in Schirmer's test, TBUT, or fluorescein and rose bengal staining was found at any time point. In the blepharoplasty-only (control group), the fluorescein staining score was reduced on postoperative day 30 as compared to baseline, but not on day 90. In this sample, addition of MMCR to upper eyelid blepharoplasty did not worsen ocular surface scores or dry eye symptoms.

Effect of a light-emitting timer device on the blink rate of non-dry eye individuals and dry eye patients.

PURPOSE: To evaluate blink rate effects by a novel light-emitting diode (LED) timer device (PISC) on non-dry eye (DE) subjects and DE patients during a reading task on liquid crystal display (LCD) screens, in different environmental conditions. METHODS: This was a case-control study that included 15 DE patients and 15 non-DE subjects as controls. Participants had their blink rates measured while they read an electronic format text. These tasks were performed in four different conditions: with and without a LED timer device in two visits, and with and without air conditioning. All participants completed the Ocular Surface Disease Index and were examined by best spectacle-corrected visual acuity exam, biomicroscopy, Schirmer test 1, fluorescein staining and break-up time and lissamine green staining (Oxford scale grading). RESULTS: Outcomes between reading tasks conditions were compared independently for each group and blink rate frequency was higher in tasks with LED timer device, with and without air conditioning, for the DE group (p<0.0001), and with air conditioning for the control group (p<0.05). CONCLUSIONS: An LED timer device increased blink frequency for DE and control groups. Further studies need to be carried out in order to evaluate long-term effects of this new device, as well as its assessment with different reading scenarios.

Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome.

PURPOSE: To determine symptoms improvement in dry eye patients with short-term autologous serum (AS) eyedrops treatment using the standardized Ocular Surface Disease Index (OSDI) survey. MATERIALS AND METHODS: A double-blind randomized crossover clinical trial was conducted, comparing short-term (2 weeks) topical treatment with AS eyedrops diluted at 20% versus conventional artificial tears treatment in adult severe dry eye syndrome (DES) patients. The main outcome measure was assessment of symptoms with OSDI survey. Secondary outcomes were corneal and conjunctival fluorescein staining score of OXFORD and tear break up time (TBUT). The protocol was registered in www.clinicaltrials.gov , ID number: NCT00779987. RESULTS: Twelve severe DES patients were included. Autologous serum treatment showed a statistically significant (p = 0.002) higher OSDI decrease (50%) versus conventional treatment (22%). There were no significant changes in objectives parameters (OXFORD and TBUT). CONCLUSIONS: Severe DES patients treated with AS achieve better symptoms improvement compared to artificial tears in a short-term treatment.

Clinical treatment of dry eye using 0.03% tacrolimus eye drops.

PURPOSE: To report the clinical outcome of the treatment of dry eyes using 0.03% tacrolimus eye drops (olive oil + tacrolimus 0.03%) (Ophthalmos, Sao Paulo, Brazil). METHODS: Sixteen eyes of 8 patients with Sjögren syndrome dry eyes (age, 51.13 ± 9.45 years) were enrolled in this study (prospective noncontrolled interventional case series). Patients were instructed to use topical 0.03% tacrolimus eye drops twice a day (every 12 hours) in the lower conjunctival sac. Schirmer I test, break-up time, corneal fluorescein, and rose bengal staining score were performed in all patients 1 day before, and 14, 28, and 90 days after treatment with 0.03% tacrolimus eye drops. RESULTS: The average fluorescein staining and rose bengal staining scores improved statistically significantly after 14 days of treatment and improved even more after 28 and 90 days. The average Schirmer I test did not improve statistically significantly after 28 days of treatment, although we did observe a significant improvement after 90 days of treatment with 0.03% tacrolimus eye drops. The average break-up time did not improve statistically after 14 days of treatment, although we observed a significant improvement after 28 and 90 days of treatment with 0.03% tacrolimus eye drops. CONCLUSIONS: Topical 0.03% tacrolimus eye drops successfully improved tear stability and ocular surface status in patients with dry eyes.

In vivo architectural analysis of 3.2 mm clear corneal incisions for phacoemulsification using optical coherence tomography.

PURPOSE: To analyze in vivo the architecture of clear corneal incisions (CCIs) for phacoemulsification using optical coherence tomography (OCT). SETTING: Anterior Segment Department, Asociacion Para Evitar la Ceguera en Mexico, Hospital Dr Luis Sanchez Bulnes, Mexico. METHODS: A prospective masked study analyzed 20 unsutured CCIs placed superiorly and created in a uniplanar fashion with a 3.2 mm slit-angled metal keratome. All wounds were evaluated with a retinal OCT model 1, 3, and 30 days postoperatively. Intraocular pressure (IOP) and incision leakage were checked. The architecture was described according to the angle of incidence, apposition of the epithelial and endothelial margins, and wound sealing. RESULTS: No leakage was detected. The angle varied from 33 to 85 degrees; angles greater than 75 degrees were done by a surgeon in training. Wound apposition at the epithelial margin was achieved in all cases. In contrast, imperfect apposition of the endothelial margin was seen in 45% of incisions on day 1 and in 15% on day 30. Incomplete sealing of the wound was seen by OCT in 25% of cases at 24 hours and persisted in 10% of all cases at 1 month. This gaping occurred on the endothelial side and never translated to the epithelial margin. No statistical correlation was found between gaping and the angle of the incision, IOP variations, or surgeon experience. CONCLUSIONS: Although in vivo CCIs caused minor anatomic imperfections, they were clinically stable independent of incision angle, IOP variation, and surgeon experience. Incision stability may be related to careful wound construction, epithelial viability, stromal edema, and efficient endothelial pumping.

Sickle Cell Retionapathy

We have conducted screening programmes at King's College Hospital for the assessment of the ocular manifestations of sickle cell disease in adults as well as in children. We have followed the same protocol used in the cohort study carried out in Jamaica. Fundus flourescein angiograms were performed on patients over the age of five. Our findings were compared to those of the Jamaican cohort. The studies were agreed by the Medical ethical committee at King's College Hospital. Some of the results have already been published. We have also documented some cases of retionopathy in patiens with AS and AC haemoglobinopathy. The eye is an invaluable window that provides an opportunity to assess the presence and progression of small vessel disease. The ocular manifestations of sickle cell haemoglobinopathies provide useful clues to the understanding of this condition. I propose to present a summary of our results so far. This study was supported by the locally organized research scheme and was conducted in association with Professor Alastair Bellingham and Dr. Arya from the Haemotology department at King's College Hospital and Professor A C Bird from Moorfields eye Hospital.(AU)

Measurement of plasma verapamil levels by high-performance liquid chromatography

1. We have developed an alternative procedure for the measurement of verapamil levels in human plasma by reverse-phase high performance liquid chromatography with fluorimetric detection. 2. Prior to assay, plasma is submitted to a double extraction procedure, using first n-heptane in alkaline medium and then an acid phosphate buffer. Flecainide, a compound not related to verapamil, is used as internal standard. Mean recoveries of 70 and 63 per cent were obtained for verapamil and flecainide, respectively. 3. The sensitivity (5 ng/ml), reproducibility (inter-assay per cent CV = 1.7-8.7; intra-assay per cent CV = 2-4) and high recovery during sample clean-up make this method useful for the quantitation of verapamil in therapeutic monitoring and pharmacokinetic studies. 4. The method is illustrated with the pharmacokinetic results obtained for 14 healthy male volunteers who received a single 240 mg dose of the commercially available tablets of Dilacoron Retard 240 mg. The mean values for the area under the curve from 0 to 24 h (AUC[0-24]), maximum achieved concentration (Cmax) and time to achieve the maximum concentration (Tmax) were 863 ng h-1 ml-1, 112 ng/ml and 4 h, respectively