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Papers in this Session
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Are Unapproved Cosmetic Contact Lens a Source of Infectious Keratitis?
Authors
Margaret C. Pollard, MD
Robert M. Shanks, PhD
Deepinder K. Dhaliwal, MD
Purpose
All contact lenses are considered FDA Class II or III medical devices, which must be obtained with a prescription. Still, unapproved cosmetic contact lenses (CCLs) are easily obtained without a prescription. This study evaluates the sterility of an illegal CCL brand sold in southwestern PA.
Methods
A single brand of unapproved CCL was purchased locally (n=6). A single brand of approved CCLs was used as a control (n=6). Unused, unopened contact packaging was disinfected. Contact immersion fluid was aseptically transferred into thioglycolate broth (incubated at 35° for 21 days), and aseptically plated on chocolate agar plates (incubated at 35° for 8 days). Viable counts of bacteria were determined on agar media. Isolated bacteria were identified with standard techniques. The CCLs were fixed in 4% paraformaldehyde buffered solution for 24 hours then transferred to PBS solution for electron microscopy analysis.
Results
A single unapproved CL was positive for 2 colonies of a Streptococcus/Enterobacter aerogenes mixture with growth in thioglycolate broth. None of the FDA approved CCL immersion fluid cultures were positive for bacteria. This may support published evidence from the FDA that unapproved CCLs can be contaminated even in reportedly sterile immersion fluid. Electron microscopy analysis is pending.
Conclusion
Unapproved CCLs may have increased rates of contamination in immersion fluid even before ocular use. Unapproved CCLs require improved regulation and enforcement to remove them from consumer markets. A severe bacterial keratitis case caused by this CCL brand prompted our study.
Margaret C. Pollard, MD
Robert M. Shanks, PhD
Deepinder K. Dhaliwal, MD
Purpose
All contact lenses are considered FDA Class II or III medical devices, which must be obtained with a prescription. Still, unapproved cosmetic contact lenses (CCLs) are easily obtained without a prescription. This study evaluates the sterility of an illegal CCL brand sold in southwestern PA.
Methods
A single brand of unapproved CCL was purchased locally (n=6). A single brand of approved CCLs was used as a control (n=6). Unused, unopened contact packaging was disinfected. Contact immersion fluid was aseptically transferred into thioglycolate broth (incubated at 35° for 21 days), and aseptically plated on chocolate agar plates (incubated at 35° for 8 days). Viable counts of bacteria were determined on agar media. Isolated bacteria were identified with standard techniques. The CCLs were fixed in 4% paraformaldehyde buffered solution for 24 hours then transferred to PBS solution for electron microscopy analysis.
Results
A single unapproved CL was positive for 2 colonies of a Streptococcus/Enterobacter aerogenes mixture with growth in thioglycolate broth. None of the FDA approved CCL immersion fluid cultures were positive for bacteria. This may support published evidence from the FDA that unapproved CCLs can be contaminated even in reportedly sterile immersion fluid. Electron microscopy analysis is pending.
Conclusion
Unapproved CCLs may have increased rates of contamination in immersion fluid even before ocular use. Unapproved CCLs require improved regulation and enforcement to remove them from consumer markets. A severe bacterial keratitis case caused by this CCL brand prompted our study.
Rho Kinase Inhibitors. Endothelial Dystrophies Approach.
Authors
Odette A. Guzman, MD
Linnette Arzeno, MD
Angie De La Mota Sr., MD
Maria T. Salazar, MD
Joaquin Lora-Hernandez, MD
Nelsy M. Fernandez, MD
Miguel A. Lopez, MD
Purpose
Establishing the effect of Rho Kinase inhibitors on endothelial morphology.
Methods
Prospective, interventional case series in patients diagnosed with Fuchs’ endothelial dystrophy at the Cornea and Refractive Surgery department from Dr. Elías Santana Hospital, Dominican Republic. A sample of 9 patients, distributed into two groups: a. Phakic eyes with diagnosis of endothelial dystrophy (5) and b. Eyes with endothelial disorders acquired after cataract surgery (4).
Results
100% female gender, average age of 66.5 ± 11.05 years. Patients treated with Ripasudil (K.115) obtained an improvement of 2 lines vision within the sixth month. Increasing percentage in cell density was 33.7% and the number of cells per field was 45.2%. Maximum corneal thickness reduction through the first twelve hours.
Conclusion
ROCK inhibitor eye drops induces transient morphological changes of corneal endothelial cells and could be considered as an alternative to graft surgery for certain forms of corneal endothelial disease.
Odette A. Guzman, MD
Linnette Arzeno, MD
Angie De La Mota Sr., MD
Maria T. Salazar, MD
Joaquin Lora-Hernandez, MD
Nelsy M. Fernandez, MD
Miguel A. Lopez, MD
Purpose
Establishing the effect of Rho Kinase inhibitors on endothelial morphology.
Methods
Prospective, interventional case series in patients diagnosed with Fuchs’ endothelial dystrophy at the Cornea and Refractive Surgery department from Dr. Elías Santana Hospital, Dominican Republic. A sample of 9 patients, distributed into two groups: a. Phakic eyes with diagnosis of endothelial dystrophy (5) and b. Eyes with endothelial disorders acquired after cataract surgery (4).
Results
100% female gender, average age of 66.5 ± 11.05 years. Patients treated with Ripasudil (K.115) obtained an improvement of 2 lines vision within the sixth month. Increasing percentage in cell density was 33.7% and the number of cells per field was 45.2%. Maximum corneal thickness reduction through the first twelve hours.
Conclusion
ROCK inhibitor eye drops induces transient morphological changes of corneal endothelial cells and could be considered as an alternative to graft surgery for certain forms of corneal endothelial disease.
Efficacy of a Novel Ophthalmic Antibiotic Combination Towards a Diverse Panel of Clinical Staphylococcus Aureus ocular Isolates.
Authors
Emily L. Laskey
Yimin T. Chen
Emma M. Gruber
Michaelle Chojnacki, PhD
Rachel A. Wozniak, MD, PhD
Purpose
To further the pre-clinical development of a novel, topical ophthalmic antibiotic drug combination for the treatment of bacterial keratitis by assessing efficacy towards a large collection of clinically relevant S. aureus ocular isolates.
Methods
163 S. aureus ocular isolates (81% derived from cornea/conjunctiva) were obtained from geographically diverse regions including North America (n=110), Europe (n=30), Latin America (n=9), Africa (n=2), Asia (n=3) and the Middle East (n=9) between 2008-2017. The in vitro minimum inhibitory concentration (MIC) was determined for relevant ophthalmic antibiotics including: vancomycin, erythromycin, polymyxin B/trimethoprim (PT), trimethoprim, rifampin, moxifloxacin, levofloxacin, and tobramycin. The novel drug combination PT + rifampin, which has been previously shown to display synergistic antimicrobial activity, was then tested for efficacy against this clinical isolate collection.
Results
Among the 163 S. aureus isolates (F=79, M=84, median age=45), 50 (30.6%) were classified as methicillin-resistant (MRSA). Significant resistance was found to erythromycin (67% resistant), levofloxacin (39%), moxifloxacin (35%), tobramycin (16%) and PT (8%). Multidrug resistance (resistant to greater than 3 antibiotic classes) was identified in 58 (35.5%) of all isolates, with 68% of MRSA isolates considered multidrug resistant. All 163 isolates were sensitive to vancomycin. The combination of PT + rifampin demonstrated synergistic antimicrobial activity towards the clinical isolate set, including strains with existing PT and fluoroquinolone resistance.
Conclusion
PT + rifampin has been previously shown to have in vitro and in vivo efficacy towards a limited set of laboratory and clinical strains of S. aureus. This current study extends this efficacy to a diverse panel of clinical S. aureus isolates from around the globe, thus furthering the promise of this drug combination for the treatment of keratitis.
Emily L. Laskey
Yimin T. Chen
Emma M. Gruber
Michaelle Chojnacki, PhD
Rachel A. Wozniak, MD, PhD
Purpose
To further the pre-clinical development of a novel, topical ophthalmic antibiotic drug combination for the treatment of bacterial keratitis by assessing efficacy towards a large collection of clinically relevant S. aureus ocular isolates.
Methods
163 S. aureus ocular isolates (81% derived from cornea/conjunctiva) were obtained from geographically diverse regions including North America (n=110), Europe (n=30), Latin America (n=9), Africa (n=2), Asia (n=3) and the Middle East (n=9) between 2008-2017. The in vitro minimum inhibitory concentration (MIC) was determined for relevant ophthalmic antibiotics including: vancomycin, erythromycin, polymyxin B/trimethoprim (PT), trimethoprim, rifampin, moxifloxacin, levofloxacin, and tobramycin. The novel drug combination PT + rifampin, which has been previously shown to display synergistic antimicrobial activity, was then tested for efficacy against this clinical isolate collection.
Results
Among the 163 S. aureus isolates (F=79, M=84, median age=45), 50 (30.6%) were classified as methicillin-resistant (MRSA). Significant resistance was found to erythromycin (67% resistant), levofloxacin (39%), moxifloxacin (35%), tobramycin (16%) and PT (8%). Multidrug resistance (resistant to greater than 3 antibiotic classes) was identified in 58 (35.5%) of all isolates, with 68% of MRSA isolates considered multidrug resistant. All 163 isolates were sensitive to vancomycin. The combination of PT + rifampin demonstrated synergistic antimicrobial activity towards the clinical isolate set, including strains with existing PT and fluoroquinolone resistance.
Conclusion
PT + rifampin has been previously shown to have in vitro and in vivo efficacy towards a limited set of laboratory and clinical strains of S. aureus. This current study extends this efficacy to a diverse panel of clinical S. aureus isolates from around the globe, thus furthering the promise of this drug combination for the treatment of keratitis.
Phase 1b Study of an Anti-Siglec-8 Monoclonal Antibody, Antolimab (AK002), in Severe Allergic Conjunctivitis
Authors
Stephen D. Anesi, MD, FACS
Joseph Tauber, MD
Gregg J. Berdy, MD, FACS
Peter Y. Chang, MD
Henrik S. Rasmussen, MD, PhD
Charles S. Foster, MD, FACS
Methods
29 patients with moderate-to-severe atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC), or perennial allergic conjunctivitis (PAC) and history of corticosteroid use were enrolled to receive six monthly doses of AK002. Clinical activity was assessed with a daily patient-reported outcome (PRO) symptom questionnaire (Allergic Conjunctivitis Symptom Score (ACS): itching, light sensitivity, eye pain, foreign body sensation, watering eyes) and a monthly investigator assessment of ocular signs & symptoms (OSS: itching, redness, tearing, chemosis). Clinical activity of AK002 on comorbid atopic dermatitis, asthma, and/or rhinitis was assessed by a daily PRO questionnaire.
Results
Antolimab (AK002) was well-tolerated. The most common adverse event was transient mild-to-moderate infusion related reactions (16.7% rate on first infusion; 0.7% rate on subsequent infusions). Patient reported symptom severity and investigator assessed signs and symptoms improved by 78% and 71% from baseline, respectively. Consistent improvements were reported across all signs and symptoms measured (Itching -75%; light sensitivity -57%; foreign body sensation -80%; watering eyes -76%; redness -67%; chemosis -100%). Patients with comorbid atopic dermatitis, asthma, and/or rhinitis reported improvements of similar magnitude in symptom severity of these conditions.
Conclusion
Antolimab (AK002) was well-tolerated and demonstrated substantial clinical activity in severe allergic conjunctivitis and in comorbid atopic diseases often associated with severe AC. Given its ability to deplete eosinophils and inhibit mast cells, antolimab (AK002) warrants further study in allergic conjunctivitis and other atopic diseases.
Stephen D. Anesi, MD, FACS
Joseph Tauber, MD
Gregg J. Berdy, MD, FACS
Peter Y. Chang, MD
Henrik S. Rasmussen, MD, PhD
Charles S. Foster, MD, FACS
Methods
29 patients with moderate-to-severe atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC), or perennial allergic conjunctivitis (PAC) and history of corticosteroid use were enrolled to receive six monthly doses of AK002. Clinical activity was assessed with a daily patient-reported outcome (PRO) symptom questionnaire (Allergic Conjunctivitis Symptom Score (ACS): itching, light sensitivity, eye pain, foreign body sensation, watering eyes) and a monthly investigator assessment of ocular signs & symptoms (OSS: itching, redness, tearing, chemosis). Clinical activity of AK002 on comorbid atopic dermatitis, asthma, and/or rhinitis was assessed by a daily PRO questionnaire.
Results
Antolimab (AK002) was well-tolerated. The most common adverse event was transient mild-to-moderate infusion related reactions (16.7% rate on first infusion; 0.7% rate on subsequent infusions). Patient reported symptom severity and investigator assessed signs and symptoms improved by 78% and 71% from baseline, respectively. Consistent improvements were reported across all signs and symptoms measured (Itching -75%; light sensitivity -57%; foreign body sensation -80%; watering eyes -76%; redness -67%; chemosis -100%). Patients with comorbid atopic dermatitis, asthma, and/or rhinitis reported improvements of similar magnitude in symptom severity of these conditions.
Conclusion
Antolimab (AK002) was well-tolerated and demonstrated substantial clinical activity in severe allergic conjunctivitis and in comorbid atopic diseases often associated with severe AC. Given its ability to deplete eosinophils and inhibit mast cells, antolimab (AK002) warrants further study in allergic conjunctivitis and other atopic diseases.
Tacrolimus 0.1% As an Alternative to Loteprednol 0.5 % in the Management of Nummular Keratitis – a Pilot Study in 100 Cases
Author
Madhu Uddaraju, MS
Purpose
To study the efficacy of tacrolimus 0.1 % eye ointment for Nummular keratitis Vs Loteprednol 0.5%
Methods
This prospective pilot study that was double blinded involved 100 cases of nummular keratitis post adenoviral kertoconjunctivitis randomly either in to a group that receive loteprednol 0.5% or Tacrolimus 0.1% . Each patient was followed at an interval of 1 week and was assessed for symptomatic relief and reduction of clinical signs of keratitis. The patient was also followed up for a period of 6 months post keratitis resolution to see for recurrences.
Results
52 cases were enrolled in the Tacrolimus group and 48 cases were enrolled in loteprednol group. Symptomatic relief and reduction in clinical signs of allergy were comparable in both the groups with 48 cases tacrolimus group and 44 cases in loteprednol group healed completely with in 4 weeks of treatment with no statistical difference.The remaining cases healed with prolonged therapy. Recurrences when followed up over a period of 6 months were relatively more in the Loteprednol group 7 when compared to 1 in tacrolimus group which was statistically significant (p value =.0193)
Conclusion
Tacrolimus 0.1% eye ointment may be used as safe and viable alternative to steroids like loteprednol in management of nummular keratitis. It also has a potential role in preventing recurrence when compared to loteprednol .Further larger studies are required to validate our results.
Madhu Uddaraju, MS
Purpose
To study the efficacy of tacrolimus 0.1 % eye ointment for Nummular keratitis Vs Loteprednol 0.5%
Methods
This prospective pilot study that was double blinded involved 100 cases of nummular keratitis post adenoviral kertoconjunctivitis randomly either in to a group that receive loteprednol 0.5% or Tacrolimus 0.1% . Each patient was followed at an interval of 1 week and was assessed for symptomatic relief and reduction of clinical signs of keratitis. The patient was also followed up for a period of 6 months post keratitis resolution to see for recurrences.
Results
52 cases were enrolled in the Tacrolimus group and 48 cases were enrolled in loteprednol group. Symptomatic relief and reduction in clinical signs of allergy were comparable in both the groups with 48 cases tacrolimus group and 44 cases in loteprednol group healed completely with in 4 weeks of treatment with no statistical difference.The remaining cases healed with prolonged therapy. Recurrences when followed up over a period of 6 months were relatively more in the Loteprednol group 7 when compared to 1 in tacrolimus group which was statistically significant (p value =.0193)
Conclusion
Tacrolimus 0.1% eye ointment may be used as safe and viable alternative to steroids like loteprednol in management of nummular keratitis. It also has a potential role in preventing recurrence when compared to loteprednol .Further larger studies are required to validate our results.