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Papers in this Session
Expand each tab below to view the paper abstract for each paper within this session.
Results of Novel External Neural Stimulation Device for Dry Eye Patients
Authors
Laura M. Periman, MD
Cynthia Matossian, MD
Paul M. Karpecki, OD
Michael Gertner, MD
Anupam Jayaram, MD
David Kading, OD
Neil J. Friedman, MD
Methods
TEAR1 was a prospective open label study in which 108 subjects were enrolled. To be enrolled, subjects were required to have a Schirmer score < 10 mm at 5 min with anesthetic. The primary endpoint was the ability of the device to produce tears at 30 days in this group of subjects. Secondary endpoints included ability to produce tears at 90 and 180 days, Ocular Surface Disease Index (OSDI), and several other objective signs of dry eye including ocular surface staining, Tear Break Up Time, and Meibomian Gland Scores. Safety of twice per day treatments up to six months was also studied.
Results
Against a sham treatment, iTEAR demonstrated a 22 mm improvement (P<.001). In a 6 month open label study, iTEAR was used 27,000 times in 108 enrolled subjects. At 30 days, iTEAR demonstrated a 9.4 mean difference from unstimulated (CI 7.6, 11.3 mm). Schirmer score pre-stimulation increased by more than 5 mm in 32% of subjects and on average 3.3 mm in all subjects (CI 2.7, 4 mm). OSDI decreasead by 13 or more in 74% of subjects (CI 60.3, 84.5) who had severe dry eye at baseline. Corneal staining decreased by 1.9 (NEI scale). Pre-stimulation meibomian gland expression (Korb and Blackie) at 30 days increased by 6 on average from day 0 (P<.001). Adverse events were all mild with a rate <1%.
Conclusion
The data in the studies for this device are positive across multiple sign and symptom endpoints in these studies for iTEAR. These data implicate a broad mechanism of action for neuromodulation. Chronic stimulation of the nerves along the side of the nose does not lead to adverse effects in over 25,000 treatments in this study.
Laura M. Periman, MD
Cynthia Matossian, MD
Paul M. Karpecki, OD
Michael Gertner, MD
Anupam Jayaram, MD
David Kading, OD
Neil J. Friedman, MD
Methods
TEAR1 was a prospective open label study in which 108 subjects were enrolled. To be enrolled, subjects were required to have a Schirmer score < 10 mm at 5 min with anesthetic. The primary endpoint was the ability of the device to produce tears at 30 days in this group of subjects. Secondary endpoints included ability to produce tears at 90 and 180 days, Ocular Surface Disease Index (OSDI), and several other objective signs of dry eye including ocular surface staining, Tear Break Up Time, and Meibomian Gland Scores. Safety of twice per day treatments up to six months was also studied.
Results
Against a sham treatment, iTEAR demonstrated a 22 mm improvement (P<.001). In a 6 month open label study, iTEAR was used 27,000 times in 108 enrolled subjects. At 30 days, iTEAR demonstrated a 9.4 mean difference from unstimulated (CI 7.6, 11.3 mm). Schirmer score pre-stimulation increased by more than 5 mm in 32% of subjects and on average 3.3 mm in all subjects (CI 2.7, 4 mm). OSDI decreasead by 13 or more in 74% of subjects (CI 60.3, 84.5) who had severe dry eye at baseline. Corneal staining decreased by 1.9 (NEI scale). Pre-stimulation meibomian gland expression (Korb and Blackie) at 30 days increased by 6 on average from day 0 (P<.001). Adverse events were all mild with a rate <1%.
Conclusion
The data in the studies for this device are positive across multiple sign and symptom endpoints in these studies for iTEAR. These data implicate a broad mechanism of action for neuromodulation. Chronic stimulation of the nerves along the side of the nose does not lead to adverse effects in over 25,000 treatments in this study.
Tixel®, a Completely Novel Way of Treating Dry Eye
Authors
Sunil Shah, MD, FRCS
Ludger D. Hanneken, MD
Debarun Dutta, PhD
Methods
TIXEL® is a fractional skin rejuvenation treatment designed to treat wrinkles. A pilot prospective controlled study was conducted on 77 individuals with wrinkles and dry eye who were treated with TIXEL®. The study was to assess the impact of wrinkle treatment on dry eye. Participants were thoroughly screened followed by the assessment of non-invasive tear-film break up time (NITBUT) and OSDI questionnaires. This was followed by two treatments of TIXEL®, each at two-week intervals. Each treatment consisted of 10 pulses on the skin of upper and lower lid in two horizontal lines adjacent to the lid margin. Ocular dry eye signs and symptoms were assessed after 2 weeks of each treatment.
Results
Significant improvement (P<0.001) in the dry eye signs and symptoms were observed after TIXEL® treatment which was characterised by an increase in NITBUT and improvement in OSDI scores. After the first and second treatment, improvement of average NIBUT was observed in 86.5% and 93.0% participants respectively. A similar trend was observed with OSDI scores which showed 77.1% and 78.0% improvement respectively. The mean NIBUT at baseline, after the first and second treatment was 8.5±2.7, 9.5±3.4 and 12.0±3.8 seconds respectively. No side effects were noted other than mild and superficial transient skin irritation.
Conclusion
TIXEL® skin rejuvenation is a safe and efficient system in improving dry eye signs and symptoms. This technology could be highly effective for treating dry eye disease for our patients and a new tool in our armamentarium.
Sunil Shah, MD, FRCS
Ludger D. Hanneken, MD
Debarun Dutta, PhD
Methods
TIXEL® is a fractional skin rejuvenation treatment designed to treat wrinkles. A pilot prospective controlled study was conducted on 77 individuals with wrinkles and dry eye who were treated with TIXEL®. The study was to assess the impact of wrinkle treatment on dry eye. Participants were thoroughly screened followed by the assessment of non-invasive tear-film break up time (NITBUT) and OSDI questionnaires. This was followed by two treatments of TIXEL®, each at two-week intervals. Each treatment consisted of 10 pulses on the skin of upper and lower lid in two horizontal lines adjacent to the lid margin. Ocular dry eye signs and symptoms were assessed after 2 weeks of each treatment.
Results
Significant improvement (P<0.001) in the dry eye signs and symptoms were observed after TIXEL® treatment which was characterised by an increase in NITBUT and improvement in OSDI scores. After the first and second treatment, improvement of average NIBUT was observed in 86.5% and 93.0% participants respectively. A similar trend was observed with OSDI scores which showed 77.1% and 78.0% improvement respectively. The mean NIBUT at baseline, after the first and second treatment was 8.5±2.7, 9.5±3.4 and 12.0±3.8 seconds respectively. No side effects were noted other than mild and superficial transient skin irritation.
Conclusion
TIXEL® skin rejuvenation is a safe and efficient system in improving dry eye signs and symptoms. This technology could be highly effective for treating dry eye disease for our patients and a new tool in our armamentarium.
Improvement in Symptom Relief Following a Single Dose of Propylene Glycol/Hydroxypropyl-Guar Based Lubricant Eye Drops in Dry Eye Patients
Authors
Steven M. Silverstein, MD, FACS, ABO
Joseph Tauber, MD
Elizabeth Yeu, MD
Manoj S. Venkiteshwar, PhD
Methods
In a Phase IV, multicenter, open-label, interventional study, 134 adult dry eye patients (subtyped into aqueous deficient, lipid deficient and mixed dry eye) were instructed to instill 1 drop of PG/HPG twice daily for 28 days. Patient-reported outcome assessment of dry eye symptoms and soothing profile was performed using 0 (no symptoms/eyes feeling good) −10 (worst symptoms/no feeling at all) visual analog scale at 4 time points on Day 1 (baseline, 0 (immediate), 4(±1), and 8(±1) hours post-drop instillation. The ratings were categorized into 0–5 and 6–10 and analyses of change in scores from baseline on Day 1 was performed by subtype of dry eye disease.
Results
At baseline, 45.5% (61/134) patients (mean age: 59 years) reported a baseline dry eye symptom score of 6–10. Of these 61 patients, 67.2%, 77.0%, and 70.5% reported shift to 0–5 at 0, 4, 8 post-single dose, respectively. The corresponding change from baseline in median (95% CI) dry eye symptom scores was: −1 (−3,−1), −2 (−3,−2), and −2 (-2,−1). Soothing sensation of 0–5 was observed in 82.1%, 81.3%, and 82.1% at 0, 4 and 8 hours post drop with median (range) scores of 3 (0–10), 3.0 (0–10), and 3.5 (0–10) at 0, 4, and 8 hours. Reduction in dry eye symptoms from baseline and good soothing sensation were noted across all subtypes of dry eye disease at post-dose time points.
Conclusion
Treatment with a single dose of SYSTANE® Complete provided instant relief, improved dry eye symptoms, sustained symptom relief, and provided soothing sensation (up to 8 hours) across all three subtypes in dry eye patients.
Steven M. Silverstein, MD, FACS, ABO
Joseph Tauber, MD
Elizabeth Yeu, MD
Manoj S. Venkiteshwar, PhD
Methods
In a Phase IV, multicenter, open-label, interventional study, 134 adult dry eye patients (subtyped into aqueous deficient, lipid deficient and mixed dry eye) were instructed to instill 1 drop of PG/HPG twice daily for 28 days. Patient-reported outcome assessment of dry eye symptoms and soothing profile was performed using 0 (no symptoms/eyes feeling good) −10 (worst symptoms/no feeling at all) visual analog scale at 4 time points on Day 1 (baseline, 0 (immediate), 4(±1), and 8(±1) hours post-drop instillation. The ratings were categorized into 0–5 and 6–10 and analyses of change in scores from baseline on Day 1 was performed by subtype of dry eye disease.
Results
At baseline, 45.5% (61/134) patients (mean age: 59 years) reported a baseline dry eye symptom score of 6–10. Of these 61 patients, 67.2%, 77.0%, and 70.5% reported shift to 0–5 at 0, 4, 8 post-single dose, respectively. The corresponding change from baseline in median (95% CI) dry eye symptom scores was: −1 (−3,−1), −2 (−3,−2), and −2 (-2,−1). Soothing sensation of 0–5 was observed in 82.1%, 81.3%, and 82.1% at 0, 4 and 8 hours post drop with median (range) scores of 3 (0–10), 3.0 (0–10), and 3.5 (0–10) at 0, 4, and 8 hours. Reduction in dry eye symptoms from baseline and good soothing sensation were noted across all subtypes of dry eye disease at post-dose time points.
Conclusion
Treatment with a single dose of SYSTANE® Complete provided instant relief, improved dry eye symptoms, sustained symptom relief, and provided soothing sensation (up to 8 hours) across all three subtypes in dry eye patients.
Efficacy of Topical 0.1% Cyclosporine in Chondroitin Sulfate Ophthalmic Emulsion in Patients with Dry Eye
Authors
Cynthia Matossian, MD
William B. Trattler, MD, ABO
Jennifer M. Loh, MD, ABO
Methods
In this retrospective, multicenter study, records for patients 18 years of age or older with dry eye who were treated with cyclosporine 0.1% drops (Klarity-C, ImprimisRx) were reviewed. There were no other exclusion criteria. Primary endpoints were the mean Ocular Surface Disease Index (OSDI) score and mean corneal staining grade from baseline to 3 months post-treatment.
Results
Results for 66 eyes of 33 subjects are available to date. The mean age was 62 (range 27-80) and 76% were female. Mean OSDI score improved from 39.99 at baseline to 20.58 at 3 months (p<0.001). Severity of OSDI decreased with the share classified as “severe” declining from 63.6% to 12.1%, and more than one-third of eyes in the “normal” OSDI range at 3 months. Mean corneal staining grade decreased from 4.11 at baseline to 2.35 after 3 months. The share of eyes with Grade 2 or 3 staining decreased from 16% at baseline to 9% after 3 months of treatment. Analysis of approximately 20 additional subjects is planned.
Conclusion
Dry eye patients treated with 0.1% cyclosporine in chondroitin sulfate experienced marked improvements in OSDI score and significant reductions in corneal staining after three months of topical therapy.
Cynthia Matossian, MD
William B. Trattler, MD, ABO
Jennifer M. Loh, MD, ABO
Methods
In this retrospective, multicenter study, records for patients 18 years of age or older with dry eye who were treated with cyclosporine 0.1% drops (Klarity-C, ImprimisRx) were reviewed. There were no other exclusion criteria. Primary endpoints were the mean Ocular Surface Disease Index (OSDI) score and mean corneal staining grade from baseline to 3 months post-treatment.
Results
Results for 66 eyes of 33 subjects are available to date. The mean age was 62 (range 27-80) and 76% were female. Mean OSDI score improved from 39.99 at baseline to 20.58 at 3 months (p<0.001). Severity of OSDI decreased with the share classified as “severe” declining from 63.6% to 12.1%, and more than one-third of eyes in the “normal” OSDI range at 3 months. Mean corneal staining grade decreased from 4.11 at baseline to 2.35 after 3 months. The share of eyes with Grade 2 or 3 staining decreased from 16% at baseline to 9% after 3 months of treatment. Analysis of approximately 20 additional subjects is planned.
Conclusion
Dry eye patients treated with 0.1% cyclosporine in chondroitin sulfate experienced marked improvements in OSDI score and significant reductions in corneal staining after three months of topical therapy.
Prevalence of Artificial Tear Use with Cyclosporine or Lifitegrast: An AAO IRIS® Registry Analysis
Authors
Elizabeth Yeu, MD
Thao N. Yeh, OD, PhD, MPH
Mohinder Merchea, OD, PhD
Methods
Non-interventional, retrospective database analysis of the IRIS® Registry. Adult patients with prescriptions for CsA 0.05% or lifitegrast 5% (brand or generic) between January 1, 2016 and June 30, 2019 were included in the primary analysis cohort and between October 1, 2018 and June 30, 2019 for the secondary analysis cohort. Concurrent use was considered positive if pre-defined search terms for artificial tear brands or common notations were reported by the patient or recommended by the doctor. Chi-squared test statistic was used to determine statistical significance.
Results
In the primary cohort, 978,938 and 320,616 patients were prescribed CsA 0.05% (Age Mean±SD: 66.6±14.2 years; 79.6% females) and lifitegrast 5% (Age Mean±SD: 62.6±15.0 years; 79.1% females), respectively. On average, 31.0% of patients were believed to be using drug and artificial tears concurrently, slightly more with lifitegrast 5% (33.3%) compared to CsA 0.05% (30.2%) (p<0.001). In the secondary cohort, 47.7% of patients using CsA or lifitegrast + artificial tears were diagnosed with MGD, and a greater proportion of those patients were using lifitegrast 5% (50.2%) than with CsA 0.05% (46.4%) (p<0.001).
Conclusion
Approximately one-third of patients prescribed either CsA or lifitegrast for dry eye disease were using artificial tears concurrently. Approximately half of patients using CsA or lifitegrast had a diagnosis of MGD.
Elizabeth Yeu, MD
Thao N. Yeh, OD, PhD, MPH
Mohinder Merchea, OD, PhD
Methods
Non-interventional, retrospective database analysis of the IRIS® Registry. Adult patients with prescriptions for CsA 0.05% or lifitegrast 5% (brand or generic) between January 1, 2016 and June 30, 2019 were included in the primary analysis cohort and between October 1, 2018 and June 30, 2019 for the secondary analysis cohort. Concurrent use was considered positive if pre-defined search terms for artificial tear brands or common notations were reported by the patient or recommended by the doctor. Chi-squared test statistic was used to determine statistical significance.
Results
In the primary cohort, 978,938 and 320,616 patients were prescribed CsA 0.05% (Age Mean±SD: 66.6±14.2 years; 79.6% females) and lifitegrast 5% (Age Mean±SD: 62.6±15.0 years; 79.1% females), respectively. On average, 31.0% of patients were believed to be using drug and artificial tears concurrently, slightly more with lifitegrast 5% (33.3%) compared to CsA 0.05% (30.2%) (p<0.001). In the secondary cohort, 47.7% of patients using CsA or lifitegrast + artificial tears were diagnosed with MGD, and a greater proportion of those patients were using lifitegrast 5% (50.2%) than with CsA 0.05% (46.4%) (p<0.001).
Conclusion
Approximately one-third of patients prescribed either CsA or lifitegrast for dry eye disease were using artificial tears concurrently. Approximately half of patients using CsA or lifitegrast had a diagnosis of MGD.
Semifluorinated Alkane Eye Drops for Postoperative Treatment of Evaporative Dry Eye Disease after Cataract Surgery
Authors
Tadas Naujokaitis, MD
Hyeck Soo Son, MD
Timur M. Yildirim, MD
Ramin Khoramnia, MD
Isabella D. Baur, MD
Piyanut Poompokawat, MD
Gerd U. Auffarth, MD, PhD
Methods
This prospective, single-center, open-label clinical trial included 40 patients undergoing cataract surgery and showing symptoms of evaporative DED as measured by the Symptom Assessment in Dry Eye (SANDE) questionnaire and Ocular Surface Disease Index (OSDI), and Tear Break-Up Time (TBUT) of <10 seconds. EvoTears was prescribed four-times-a-day for 5 weeks and administrated 15 minutes after standard postoperative topical anti-inflammatory regimen. Primary endpoint was the change in TBUT. Secondary endpoints included assessment of subjective symptoms (SANDE/OSDI), corrected distance visual acuity, slit-lamp examination, and Schirmer’s test at 1 day, 1 week and 5 weeks postoperatively.
Results
At 5 weeks postoperatively, the median TBUT increased from 6.8 (preoperative) to 14.0 seconds (Wilcoxon signed-rank test: p<0.001) and the average total corneal staining score decreased from 3.53 (preoperative) to 2.36 (paired t-test: p<0.001). The mean corrected distance visual acuity improved from 0.41 (preoperative) to 0.14 logMAR (paired t-test: p<0.001) and there was a statistically significant decrease in all scores from the SANDE/OSDI questionnaire at 5 weeks postoperatively. There was no statistically significant change in Schirmer's test (paired t-test: p=0.150).
Conclusion
Tear film, ocular surface, and subjective impressions of DED patients were improved during 5 weeks after cataract surgery. Patients’ and physicians’ assessment indicated good efficacy and high tolerability of EvoTears, suggesting its suitability in postoperative management of the ocular surface in DED patients.
Tadas Naujokaitis, MD
Hyeck Soo Son, MD
Timur M. Yildirim, MD
Ramin Khoramnia, MD
Isabella D. Baur, MD
Piyanut Poompokawat, MD
Gerd U. Auffarth, MD, PhD
Methods
This prospective, single-center, open-label clinical trial included 40 patients undergoing cataract surgery and showing symptoms of evaporative DED as measured by the Symptom Assessment in Dry Eye (SANDE) questionnaire and Ocular Surface Disease Index (OSDI), and Tear Break-Up Time (TBUT) of <10 seconds. EvoTears was prescribed four-times-a-day for 5 weeks and administrated 15 minutes after standard postoperative topical anti-inflammatory regimen. Primary endpoint was the change in TBUT. Secondary endpoints included assessment of subjective symptoms (SANDE/OSDI), corrected distance visual acuity, slit-lamp examination, and Schirmer’s test at 1 day, 1 week and 5 weeks postoperatively.
Results
At 5 weeks postoperatively, the median TBUT increased from 6.8 (preoperative) to 14.0 seconds (Wilcoxon signed-rank test: p<0.001) and the average total corneal staining score decreased from 3.53 (preoperative) to 2.36 (paired t-test: p<0.001). The mean corrected distance visual acuity improved from 0.41 (preoperative) to 0.14 logMAR (paired t-test: p<0.001) and there was a statistically significant decrease in all scores from the SANDE/OSDI questionnaire at 5 weeks postoperatively. There was no statistically significant change in Schirmer's test (paired t-test: p=0.150).
Conclusion
Tear film, ocular surface, and subjective impressions of DED patients were improved during 5 weeks after cataract surgery. Patients’ and physicians’ assessment indicated good efficacy and high tolerability of EvoTears, suggesting its suitability in postoperative management of the ocular surface in DED patients.
Lid Debridement and Thermal Pulsation Treatment to Improve Tears Film Quality and Biometry Accuracy to Broaden Trifocal IOLs Adoption
Authors
Barbara Kusa, MD
Matteo Piovella, MD
Methods
Cataract surgeons have to improve tear film quality to get a better corneal surface and to improve biometry efficiency to approach multifocal IOLs implantation Not considering the importance of eyelid debridement before apply MG thermal pulsation treatment could penalize postop quality of vision and provide unhappy patients 52 patients (mean age 62.12±13 years) were diagnosed with partial or total Meibomian glands occlusion by LipiView lids transillumination. Patients received a LipiFlow treatment to remove obstructions and restore meibomian gland function after applying a lid debridement with Blephex . After the treatments specific eyedrops therapy was applied for at least three weeks
Results
Symptoms had decreased at 1 month post treatments.Patients reported no significant discomfort or pain during or after treatment. Postop quality of vision improved due a better corneal tears film and also the biometry measurements were MG appeared mainly not occluded Biometry were more accurate, comparable and repeatable than the tests carried out before the treatments . We found significant differences from the values of biometry: 25 degrees for the astigmatism axis, up to one diopter difference for both astigmatism and spherical equivalent. In assessing these results, consider the importance of falling within the range of 0.50 remaining diopters in the postoperative time.
Conclusion
Refractive cataract surgery is based on to achieve good refractive outcome within a range of 0.50 diopters after surgery Two lid treatments provide an effective way to detect MG occlusion and to treat succesfully the majority of the patients patients.This treatment helps to adopt presbyopic implants over 50% of cataract patients
Barbara Kusa, MD
Matteo Piovella, MD
Methods
Cataract surgeons have to improve tear film quality to get a better corneal surface and to improve biometry efficiency to approach multifocal IOLs implantation Not considering the importance of eyelid debridement before apply MG thermal pulsation treatment could penalize postop quality of vision and provide unhappy patients 52 patients (mean age 62.12±13 years) were diagnosed with partial or total Meibomian glands occlusion by LipiView lids transillumination. Patients received a LipiFlow treatment to remove obstructions and restore meibomian gland function after applying a lid debridement with Blephex . After the treatments specific eyedrops therapy was applied for at least three weeks
Results
Symptoms had decreased at 1 month post treatments.Patients reported no significant discomfort or pain during or after treatment. Postop quality of vision improved due a better corneal tears film and also the biometry measurements were MG appeared mainly not occluded Biometry were more accurate, comparable and repeatable than the tests carried out before the treatments . We found significant differences from the values of biometry: 25 degrees for the astigmatism axis, up to one diopter difference for both astigmatism and spherical equivalent. In assessing these results, consider the importance of falling within the range of 0.50 remaining diopters in the postoperative time.
Conclusion
Refractive cataract surgery is based on to achieve good refractive outcome within a range of 0.50 diopters after surgery Two lid treatments provide an effective way to detect MG occlusion and to treat succesfully the majority of the patients patients.This treatment helps to adopt presbyopic implants over 50% of cataract patients