Double-masked, sham and placebo-controlled trial of corneal cross-linking and topical difluprednate in the treatment of bacterial keratitis: Steroids and Cross-linking for Ulcer Treatment Trial (SCUT II) study protocol

IntroductionAlthough antibiotics are successful at achieving microbiological cure in infectious keratitis, outcomes are often poor due to corneal scarring. Ideal treatment of corneal ulcers would address both the infection and the inflammation. Adjunctive topical steroid treatment may improve outcomes by reducing inflammation. Corneal cross-linking (CXL) is a novel prospective therapy that may simultaneously reduce both inflammatory cells and bacterial pathogens. The purpose of this study is to determine differences in 6-month visual acuity between standard medical therapy with antibiotics versus antibiotics with adjunctive early topical steroid therapy versus antibiotic treatment plus CXL and early topical steroids.Methods and analysisThis international, randomised, sham and placebo-controlled, three-arm clinical trial randomises patients with smear positive bacterial ulcers in a 1:1:1 fashion to one of three treatment arms: (1) topical 0.5% moxifloxacin plus topical placebo plus sham CXL; (2) topical 0.5% moxifloxacin plus difluprednate 0.05% plus sham CXL; or (3) the CXL group: topical 0.5% moxifloxacin plus difluprednate 0.05% plus CXL.Ethics and disseminationWe anticipate that both adjunctive topical steroids and CXL will improved best spectacle corrected visual acuity and also reduce complications such as corneal perforation and the need for therapeutic penetrating keratoplasty. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. Our results will be disseminated via ClinicalTrials.gov website, meetings and journal publications. Our data will also be available on reasonable request.Trial registration numberNCT04097730.

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Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Trials ◽

10.1186/s13063-021-05922-1 ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Yibo Li ◽

Lili Zhu ◽

Raoying Wang ◽

Xingyue Yang ◽

Xinqi Jiang ◽

...

Keyword(s):

Clinical Trial ◽

Visual Acuity ◽

Controlled Trial ◽

Control Group ◽

Health Maintenance ◽

Ocular Symptoms ◽

Thought Disorders ◽

Multicenter Randomized Controlled Trial ◽

Distant Visual Acuity

Abstract Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020

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Polymicrobial keratitis after accelerated corneal collagen cross-linking in keratoconus: Case reports and literature review

European Journal of Ophthalmology ◽

10.1177/11206721211051922 ◽

2021 ◽

pp. 112067212110519

Author(s):

Ying Lu ◽

Yewei Yin ◽

Tu Hu ◽

Kaixuan Du ◽

Yanyan Fu ◽

...

Keyword(s):

Literature Review ◽

Case Reports ◽

Cross Linking ◽

Retrospective Case ◽

Corneal Epithelial ◽

Corneal Scarring ◽

Corneal Ulcers ◽

First Case ◽

Collagen Cross Linking ◽

Corneal Collagen

Purpose To report two cases of polymicrobial keratitis following corneal collagen cross-linking for keratoconus and to review the literature. Methods Retrospective case note and literature review. Results The first case involved a 27-year-old male who presented with amebic corneal ulcers 3 days after the collagen cross-linking procedure. Some gram-negative (gram-ve) cocci were found upon staining, and cysts were observed by confocal microscopy at 7 days after surgery. Acanthamoeba infection mixed with gram-ve organisms was diagnosed. In the second case, a 14-year male developed Staphylococcus aureus corneal infection with anterior chamber empyema 3 days after the collagen cross-linking procedure for keratoconus. Occasional gram-positive (gram + ve) cocci and gram-ve bacilli were observed under a microscope. The mixed keratitis in the two patients resolved after systemic and topical antibiotic therapy, but the infection ultimately resulted in corneal scarring. Follow-up keratoplasty was needed to improve vision acuity in both patients. Conclusion Although ultraviolet irradiation and the reactive oxygen released by riboflavin during collagen cross-linking have bactericidal effects, a lack of a corneal epithelial barrier, bandage contact lens usage, perioperative hygiene, and an abnormal immune state are risk factors for infectious keratitis after collagen cross-linking. Perioperative management of collagen cross-linking is important to prevent infection.

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Diffuse Sterile Corneal Infiltration: An Unusual Complication Post Collagen Cross-linkage

International Journal of Keratoconus and Ectatic Corneal Diseases ◽

10.5005/jp-journals-10025-1111 ◽

2015 ◽

Vol 4 (3) ◽

pp. 115-119 ◽

Cited By ~ 1

Author(s):

Ritu Arora ◽

Sonal Dangda

Keyword(s):

Visual Acuity ◽

Rare Complication ◽

Cross Linking ◽

Unusual Complication ◽

Topical Steroids ◽

Poor Vision ◽

Corneal Clouding ◽

Cross Linkage

ABSTRACT Purpose Presenting the course of visually disabling corneal infiltration post uneventful collagen cross-linking (CXL) in a 23 years old male with bilateral keratoconus. Methods A 23 years old male with bilateral keratoconus underwent cross-linking of left eye with indigenous 0.1% riboflavin dye and 370 nm ultraviolet A irradiation. This patient had an uneventful successful cross-linking performed in right eye 6 months prior with good recovery of vision to LogMAR (6/9 Snellen). Results Patient developed diminution of vision, along with redness of eye, photophobia and watering on 3rd day after uneventful cross-linkage. Examination revealed very poor vision; diffuse corneal clouding with multiple superficial stromal infiltrates and incomplete corneal epithelization. A provisional diagnosis of infective keratitis was made, in situ bandage contact lens (BCL) removed and subjected to culture. Intensive fortified topical antibiotics were initiated and steroids withheld. After complete corneal re-epithelization on 6th day, the infiltrations did not decrease in either intensity or number. Response to antibiotics being inadequate, an immune etiology was suspected and full strength topical steroids reinstituted which resulted in slow resolution of infiltration over a 10 weeks period. Last follow-up at 9 months post-CXL, revealed a diffuse stromal haze with unaided visual acuity of LogMAR 0.8 6/36 and best-corrected visual acuity (BCVA) of 0.3 (6/12) with use of a rigid gas permeable lens. Conclusion Sterile infiltration post-CXL requiring intense topical steroids is a rare complication of CXL and needs to be differentiated from infective keratitis. How to cite this article Bhattacharyya M, Singh K, Mutreja A, Dangda S, Arora R. Diffuse Sterile Corneal Infiltration: An Unusual Complication Post Collagen Cross-linkage. Int J Kerat Ect Cor Dis 2015;4(3):115-119.

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Guided Meditation For Vision Acuity Training On Adolescent Myopia: Study Protocol For A Prospective, Multicenter, Randomized Controlled Trial

10.21203/rs.3.rs-450181/v1 ◽

2021 ◽

Author(s):

Yibo Li ◽

Lili Zhu ◽

Raoying Wang ◽

Xinqi Jiang ◽

Tao Lu

Keyword(s):

Clinical Trial ◽

Visual Acuity ◽

Controlled Trial ◽

Control Group ◽

Health Maintenance ◽

Ocular Symptoms ◽

Thought Disorders ◽

Multicenter Randomized Controlled Trial ◽

Distant Visual Acuity

Abstract Background: Currently, the population with myopia climbs steadily, and developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness and other complications. At present, the solutions for myopia are glasses, medication and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods: This is a prospective, randomized, multicenter clinical trial. 1140 primary and secondary school students aged 8-18 years old from 27 schools will be recruited and randomly divided into an experimental group and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and -6.00D ≤ spherical lenses ≤ -0.50D, cylindrical lenses ≤ 1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter and astigmatism. Discussion: The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration: Chinese Clinical Trial Registry (identifier: ChiCTR2000038642; Registered 26 September 2020, http://www.chictr.org.cn/showproj.aspx?proj=61729).

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Ulcerative keratitis in gatrointestinal stromal tumor patients treated with perifosine

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.19664 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 19664-19664

Author(s):

B. Esmaeli ◽

J. Trent ◽

L. Espandar ◽

E. Hatef ◽

S. K. Kim ◽

...

Keyword(s):

Visual Acuity ◽

Visual Loss ◽

Signs And Symptoms ◽

Topical Steroids ◽

Close Monitoring ◽

Phase Ii Trials ◽

Topical Antibiotics ◽

Corneal Scarring ◽

Ocular Symptoms ◽

Ulcerative Keratitis

19664 Background: Perifosine is a novel, oral, alkylphospholipid with antiproliferative properties attributed to Akt inhibition. We describe the ocular findings in 5 patients enrolled in phase I/phase II trials of perifosine in combination with imatinib for treatment of advanced GIST. Methods: The medical records of 5 patients who developed peripheral ulcerative keratitis while receiving perifosine and imatinib were retrospectively reviewed. Results: 1 man and 4 women ranged in age from 43 to 72 (median, 57 years). The ocular symptoms included redness, irritation, tearing, photophobia and a gradual decrease in vision. Slit lamp biomicroscopy in each case revealed a peripheral, paralimbal, ring-shaped, superficial stromal infiltration and ulcerative keratitis (UK), reminiscent of the autoimmune keratitis in conditions such as rheumatoid arthritis. The best corrected visual acuity in the affected eye(s) ranged from 20/25 to 20/300 (median 20/70). The UK was unilateral in 3 and bilateral in 2 patients; it was NCI grade II in all. All 6 patients had imatinib-resistant metastatic GIST and had continued on the highest dose of imatinib tolerated and initiated therapy with perifosine 100 mg daily or 900 mg weekly. Time from start of perifosine therapy to diagnosis of UK ranged from 1 to 3 months (median, 2). A combination of topical steroids, topical antibiotics and lubricating drops were used to manage UK. In the first 3 patients, UK was initially treated with topical antibiotics without improvement, but subsequently improved significantly once topical steroids were added. In 5 of 6 patients, the visual acuity improved with this regimen. Conclusions: UK may occur as a side effect of perifosine and shares features of autoimmune forms of keratitis. It is possible that imatinib in combination with perifosine is contributing to this toxicity. Topical steroids improve the signs and symptoms of UK and early treatment with topical steroids may lessen the potential risk of permanent corneal scarring and visual loss. The visual loss associated with perifosine can be reversible with close monitoring and judicious use of topical steroids, topical antibiotic coverage, and lubrication. No significant financial relationships to disclose.

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Assessing the Effect of Clinical Trial Evidence and Anecdote on Caregivers’ Willingness to Use Corticosteroids: A Randomized Controlled Trial

Journal of Cutaneous Medicine and Surgery ◽

10.1177/1203475419871050 ◽

2019 ◽

Vol 24 (1) ◽

pp. 17-22 ◽

Cited By ~ 2

Author(s):

Matthew C. Johnson ◽

Adrian Pona ◽

Adrienne L. Adler-Neal ◽

Chelsea Kesty ◽

Abigail Cline ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Safety Information ◽

Topical Steroid ◽

Dermatology Clinic ◽

Clinical Trial Evidence ◽

Willingness To Use ◽

To Receive ◽

Trial Evidence ◽

High Willingness

Background: Treatment of childhood atopic dermatitis (AD) is hindered by nonadherence, but caregiver reassurance may help overcome this hurdle. Objectives: To assess caregivers’ willingness to treat childhood AD with a corticosteroid when presented with clinical trial evidence, anecdote, or both. Methods: A total of 476 caregivers were recruited through a dermatology clinic and online crowdsourcing platform. Subjects were randomized to receive clinical trial evidence, anecdote, or both, using either the term “medication” or “topical steroid.” Additional caregivers were queried about their willingness to treat with the doctor’s recommendation or without knowledge of its safety information. Responses were recorded on a 10-point Likert scale. Results: Caregivers’ willingness to treat was higher in all information assignment groups compared to those not provided with safety information: clinical trial evidence of a “medication” ( P = .003; Cohen’s d = 0.83) or “topical steroid” ( P = .030; d = 0.55), anecdote of a “medication” ( P < .0001; d = 1.37) or “topical steroid” ( P < .0001; d = 0.85), both clinical trial evidence and anecdote of a “medication” ( P < .0001; d = 1.00) or “topical steroid” ( P = .000; d = 0.89), and simply the doctor’s recommendation ( P < .0001; d = 0.92). Significance was corrected for multiple comparisons to 0.0018. There were no differences between caregivers of children with and without AD ( P = .36). Conclusions: Providing anecdotal reassurance, even in the setting of reported high willingness to treat with the doctor’s recommendation, may be an effective strategy to improve caregivers’ perceptions of starting new medications.

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A comparison of therapies using Eyetronix Flicker Glass and standard adhesive patches in children with anisometropic amblyopia: A randomized controlled trial

10.1101/2020.07.20.20157552 ◽

2020 ◽

Author(s):

Seung Hyun Min ◽

Shijia Chen ◽

Jinling Xu ◽

Bingzhen Chen ◽

Hui Chen ◽

...

Keyword(s):

Clinical Trial ◽

Visual Acuity ◽

Contrast Sensitivity ◽

Primary Outcome ◽

Controlled Trial ◽

Trial Registry ◽

Clinical Trial Registry ◽

Treatment Groups ◽

Anisometropic Amblyopia ◽

Randomized Controlled

AbstractPurposeRecently, Eyetronix Flicker Glass (EFG) was introduced as a novel treatment for amblyopia. We conducted a randomized clinical trial to compare the efficacy of the therapies using the Eyetronix Flicker Glass and standard adhesive patches.MethodsWe tested 31 children (aged 4-13 years) with anisometropic amblyopia. They were assigned into one of the two treatment groups and were treated for 12 weeks. The first group was treated with the Eyetronix Flicker Glass for one hour per day (Flicker Group), and the latter with standard patches (Patching Group) for two hours per day. We considered best-corrected visual acuity (BVCA) of the amblyopic eye after 12 weeks of treatment as the primary outcome. Secondary outcomes were BVCA of the amblyopic at other timepoints of measurement (before the treatment, 3 and 6 weeks) as well as contrast sensitivity of the amblyopic eye, stereopsis and fusion range at all timepoints.ResultsVisual acuity in the amblyopic eye was significantly improved in both treatment groups at week 12 relative to baseline. The magnitude of improvement was similar. Contrast sensitivity of the amblyopic eye at 3, 6 and 12 cpd was large but not so at 18 cpd for both groups. Stereopsis did not improvement in both groups. However, fusion range significantly improved in the Flicker Group at week 12 relative to baseline.ConclusionAfter 12 weeks, EFG therapy improves amblyopic eye’s visual acuity, its contrast sensitivity and fusion range of the patients. EFG therapy improves both monocular and binocular functions.Clinical trial registry numberChiCTR2000034436 from the Chinese Clinical Trial Registry

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Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06356-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Marouf Alhalabi ◽

Mohammed Waleed Alassi ◽

Kamal Alaa Eddin ◽

Khaled Cheha

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Confidence Interval ◽

Odds Ratio ◽

Controlled Trial ◽

Helicobacter Pylori Infection ◽

First Line ◽

Link Type ◽

Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

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