scholarly journals Treatment of Dry Eye With Intracanalicular Injection of Hydroxybutyl Chitosan: A Prospective Randomized Clinical Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Tong Lin ◽  
Wushuang Wang ◽  
Yang Lu ◽  
Lan Gong

Background: Punctal/intracanalicular plugs on the market nowadays are all designed before clinical use in treating dry eye disease (DED). To provide an individualized lacrimal drainage system occlusion method and reduce the complications, we developed a “liquid plug” strategy by intracanalicular injection of hydroxybutyl chitosan (HBC) solution, a thermosensitive, phase-changing biomaterial. This study evaluated the efficacy and safety of the HBC plug in treating dry eye disease by comparing it with the VisiPlug absorbable intracanalicular plug.Methods: A monocenter, randomized, controlled clinical trial was performed. Fifty patients with DED were randomized 1:1 to undergo either the HBC injection treatment or the VisiPlug treatment. Ocular Surface Disease Index (OSDI) questionnaire, tear break-up time (TBUT), corneal fluorescence staining (CFS), tear meniscus height (TMH), and phenol red thread test were evaluated at Day 0 (baseline, before treatment) and Weeks 1, 4, and 12.Results: The two groups had a balanced baseline of age, gender, and DED-related characteristics. Both occlusion methods could relieve the symptoms and signs of DED. Significant improvement was found in OSDI, phenol red thread test, and tear meniscus height (P < 0.05 compared to baseline) but not in corneal fluorescence staining and tear break-up time (P > 0.05). There is no statistically significant difference between HBC injection and VisiPlug at Weeks 1 and 4 (P > 0.05). However, at week 12, the HBC injection was not as effective as the VisiPlug in maintaining phenol red thread test (HBC: 5.35 ± 3.22 mm, VisiPlug: 8.59 ± 4.35 mm, P = 0.009) and tear meniscus height (HBC: 206.9 ± 47.95 μm, VisiPlug: 242.59 ± 60.30 μm, P = 0.041). The numbers of ocular adverse events were relatively low in both groups.Conclusions: The HBC injection showed similar efficacy and safety compared to VisiPlug. The intracanalicular injection of HBC solution proves to be a promising, individualizing method to treat DED.Clinical Trial Registration: This study is registered with the Chinese Clinical Trial Registry (https://www.chictr.org.cn/enindex.aspx), Identifier: ChiCTR1800016603.

Ophthalmology ◽  
2010 ◽  
Vol 117 (10) ◽  
pp. 1923-1929 ◽  
Author(s):  
Osama M.A. Ibrahim ◽  
Murat Dogru ◽  
Yoji Takano ◽  
Yoshiyuki Satake ◽  
Tais Hitomi Wakamatsu ◽  
...  

2019 ◽  
Vol 17 (4) ◽  
pp. 747-752 ◽  
Author(s):  
Archita Singh ◽  
Murugesan Vanathi ◽  
Alisha Kishore ◽  
Noopur Gupta ◽  
Radhika Tandon

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Lei Tian ◽  
Jing-hao Qu ◽  
Xiao-yu zhang ◽  
Xu-guang Sun

Purpose. To determine the intraexaminer repeatability and interexaminer reproducibility of tear meniscus height (TMH) and noninvasive Keratograph tear breakup time (NIKBUT) measurements obtained with the Keratograph 5M (K5M) in a sample of healthy and dry eye populations.Methods. Forty-two patients with dry eye disease (DED group) and 42 healthy subjects (healthy group) were recruited in this prospective study. In all subjects, each eye received 3 consecutive measurements using the K5M for the TMH and NIKBUTs (NIKBUT-first and NIKBUT-average). And then a different examiner repeated the measurements. The repeatability and reproducibility of measurements were assessed by the coefficient of variation (CV) and intraclass correlation coefficient (ICC).Results. The repeatability and reproducibility of TMH and NIKBUTs were good in both DED and healthy groups (CV% ≤ 26.1% and ICC ≥ 0.75 for all measurements). Patients with DED showed better intraexaminer repeatability for NIKBUTs, but worse for TMH than healthy subjects. Average TMH, NIKBUT-first, and NIKBUT-average were significantly lower in DED group than in healthy group (allPvalues < 0.05).Conclusions. Measurements of TMH and NIKBUTs obtained with the K5M may provide a simple, noninvasive screening test for dry eye with acceptable repeatability and reproducibility. The NIKBUTs were more reliable, but TMH was less reliable in patients with DED.


2016 ◽  
Vol 75 (1) ◽  
Author(s):  
Deanne L. Nicholas ◽  
Wayne D.H. Gillan

Keratoconus is a debilitating condition where the cornea develops a conical shape rather than the characteristic round shape due to various physiological and structural changes taking place within the layers of the cornea. As a result of the pathogenesis of keratoconus, there are numerous changes that may occur within the tears of these patients. Research has shown changes in the tear metabolome, the presence of degradation products as well as loss of goblet cells into the tears. Could the changes occurring within the tear structure of these patients affect the results of various tear quantity and quality tests? Non-invasive tear break up time (NTBUT) is a diagnostic test used to determine the quality of the tear film and has been used extensively when diagnosing dry eye disease. This test is utilised in order to determine the time taken for the tear film to begin breaking apart, signalling thinning of the tears. Shorter break up times are therefore indicative of instability or changes occurring within the tear film which could be diagnostic of dry eye disease. Tear meniscus height (TMH) measurements have also been utilised in clinical practice, where these measurements provide an indication of the volume of tears contained within the upper and lower menisci. Lower tear volumes have been shown to be present in cases of dry eye disease where either tear production or tear drainage may be affected. Changes in the quality and quantity of the tear film in subjects with dry eye disease have been thoroughly investigated; however, the same cannot be said for subjects with keratoconus. Could the same findings be possible in subjects with keratoconus? Is it possible that the changes occurring within the tears of keratoconic subjects could lead to abnormal NTBUT and TMH measurements when compared to those of control subjects? Could the results of the NTBUT and TMH tests be related to one another? This study compares the NTBUT and TMH measurements of both keratoconic and control subjects by making use of a single type of instrumentation, namely the Oculus Keratograph 4 (OK4). The results of this study reveal that the values obtained for each of the two subject groups are not shown to be statistically significantly different and that there is no significant correlation between the NTBUT and TMH measurements when comparing keratoconic and control subjects.


2021 ◽  
pp. 23-25
Author(s):  
Vepa Meenakshi ◽  
Maridi Aparna ◽  
Tammana v

AIM: To screen for dry eye among type 2 diabetic patients ,determine the prevalence and correlate with blood sugar levels. METHODS: 100 patients who were diagnosed cases of type 2 diabetes were included in the study .Detailed history regarding ocular symptoms, diabetes and its duration was taken. A thorough ocular examination using Slit lamp bio microscopy was done and visual acuity tested with Snellen's chart.Tear lm status evaluated by Schirmer's I test, Tear lm break up time(TBUT),Tear meniscus height. Two or all of the above performed tests was positive in a given patient, the patient was deemed to be suffering from dry eye. RESULTS:Out of 100 patients, males were 48 and females were 52. 39 patients were found to show positive screening tests for dry eye.38% (out of 39 patients) had major symptom of foreign body sensation. 23 out of 39 patients were females. 14 out of 39 patients were in age group 51 to 60 years.Most of the diabetics with dry eye had duration of disease 5 to 10 years .39 patients had Tear Break Up time <10 sec, 25 patients had Tear Meniscus Height <0.25mm and 36 patients had Schirmers I test<10mm.Diabetics with dry eyes had average RBS of 179.63+57.28 and PPBS of 247.75+88.39 mg/dl. These values were more when compared to diabetics with no dry eye. CONCLUSION: Early ocular examination in Diabetic patients and good glycemic control should be done considering increased incidence of dry eyes.This should be an integral part of the assessment of diabetic eye disease so as to improve the patient's comfort and to prevent or minimize further structural damage to the ocular surface.


2021 ◽  
Vol 37 (1) ◽  
pp. 4-11
Author(s):  
Jeongah Shin ◽  
Chang Rae Rho ◽  
Joon Young Hyon ◽  
Tae-Young Chung ◽  
Kyung Chul Yoon ◽  
...  

2018 ◽  
Vol Volume 12 ◽  
pp. 2499-2508 ◽  
Author(s):  
Marc Labetoulle ◽  
Stefanie Schmickler ◽  
David Galarreta ◽  
Daniel Boehringer ◽  
Abayomi Ogundele ◽  
...  

2016 ◽  
Vol 26 (6) ◽  
pp. 546-555 ◽  
Author(s):  
Pierre-Yves Robert ◽  
Béatrice Cochener ◽  
Mourad Amrane ◽  
Dahlia Ismail ◽  
Jean-Sébastien Garrigue ◽  
...  

2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  

Purpose The SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE). Methods In this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis®) or its vehicle for 6 months, followed by 6-month open-label, once-daily CsA CE (CsA CE/CsA CE and vehicle/CsA CE groups). Results A total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA. Conclusions In this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.


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