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Papers in this Session
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Evaluation of Improvement in Contact Lens Discomfort Using a Nanodroplet Artificial Tear
Authors
Alanna S. Nattis, DO
Andrew D. Pucker, OD, PhD
Christopher W. Lievens, OD, MS
Gerald McGwin Jr., PhD, MS
Quentin X. Franklin, BScOptom
Methods
This registered, investigator-masked, two-week, randomized clinical trial recruited adult subjects with symptomatic Contact Lens Dry Eye Questionanire-8 (CLDEQ-8 scores ≥ 12) scores. Subjects were randomized to use artificial tears with an active ingredient of propylene glycol 0.6% before and after CL use or no treatment. Clinical signs (visual acuity, invasive tear breakup time, extent of corneal staining, Schirmer I test without anesthesia, and meibum quality/expression) and symptoms (CLDEQ-8, Standardized Patient Evaluation of Eye Dryness (SPEED), self-report) were evaluated at each visit.
Results
Twenty-two subjects were randomized to artificial tears; 24 were randomized to no treatment.There were no significant between group differences with respect to demographics/clinical characteristics (p>0.11) or contact lens wearing experience, habits, or CL satisfaction (p>0.19).The treatment group had significantly better CLDEQ-8 scores (12.86±6.40 vs 17.92±5.30; p =0.006) compared to no treatment; they were more likely to report subjective improvement in eye comfort at 2 weeks(p<0.001). Compared with controls, end-of-day comfort significantly improved at 2 weeks for the treatment group (p=0.045) as did comfortable wear time at 1 (p=0.006) and 2 weeks (p=0.02). No adverse events were noted.
Conclusion
This nanodroplet-technology-based artificial tear was found to safely and significantly improve CL comfort in symptomatic daily disposable CL wearers. Our results serve as an important educational tool for our patients, not only for increased CL tolerance, but also for ocular health and potential prevention of CL related complications.
Alanna S. Nattis, DO
Andrew D. Pucker, OD, PhD
Christopher W. Lievens, OD, MS
Gerald McGwin Jr., PhD, MS
Quentin X. Franklin, BScOptom
Methods
This registered, investigator-masked, two-week, randomized clinical trial recruited adult subjects with symptomatic Contact Lens Dry Eye Questionanire-8 (CLDEQ-8 scores ≥ 12) scores. Subjects were randomized to use artificial tears with an active ingredient of propylene glycol 0.6% before and after CL use or no treatment. Clinical signs (visual acuity, invasive tear breakup time, extent of corneal staining, Schirmer I test without anesthesia, and meibum quality/expression) and symptoms (CLDEQ-8, Standardized Patient Evaluation of Eye Dryness (SPEED), self-report) were evaluated at each visit.
Results
Twenty-two subjects were randomized to artificial tears; 24 were randomized to no treatment.There were no significant between group differences with respect to demographics/clinical characteristics (p>0.11) or contact lens wearing experience, habits, or CL satisfaction (p>0.19).The treatment group had significantly better CLDEQ-8 scores (12.86±6.40 vs 17.92±5.30; p =0.006) compared to no treatment; they were more likely to report subjective improvement in eye comfort at 2 weeks(p<0.001). Compared with controls, end-of-day comfort significantly improved at 2 weeks for the treatment group (p=0.045) as did comfortable wear time at 1 (p=0.006) and 2 weeks (p=0.02). No adverse events were noted.
Conclusion
This nanodroplet-technology-based artificial tear was found to safely and significantly improve CL comfort in symptomatic daily disposable CL wearers. Our results serve as an important educational tool for our patients, not only for increased CL tolerance, but also for ocular health and potential prevention of CL related complications.
Patient Satisfaction with Autologous Serum in the Treatment of Dry Eye Disease and Neurotrophic Keratitis
Authors
Tripp Harwell
Cory J. Pickett, BSN, RN, COA, OSC
Sloan W. Rush, MD, ABO
Purpose
To report satisfaction results among patients using autologous serum (AS) for the treatment of various ocular surface disorders.
Methods
The charts of 56 consecutive patients that were treated with AS for chronic ocular surface disease were reviewed. These patients were surveyed by phone interview to evaluate their experience with the treatment. The main patient reported outcome measurements included the number of coexisting treatments that were able to be discontinued due to the benefits of AS and the presence or absence of adverse events associated with the treatment. Secondary outcome variables included patient’s stated percentage improvement and the average cost for the treatment. Outcome comparisons were also made based upon underlying ocular surface pathology.
Results
A total of 32 patients participated in the study: 20 were being treated for dry eye disease (DED) and 12 were being treated for neurotrophic keratitis (NK). The average number of treatments was decreased by 3.4 (+/-1.6). Mean percentage improvement with AS was 50.5% (+/-30.2%) and two study subjects specified adverse effects linked with treatment, vision loss for both. There were 28 respondents that indicated that it worked well, however, only 16 said that they would want to do it again if given the opportunity. The average monthly out of pocket expense for the patient was $97.3(+/-$67.8) USD. There were no significant differences among the DED versus the NK groups (p>0.05 for all).
Conclusion
Autologous serum can be used with a high degree of patient satisfaction while reducing the number of simultaneous treatments that the patient must use to achieve ocular surface stability. Difficulty to access, necessity for frequent blood draws and relatively high cost are significant barriers for patient desirability for this treatment modality.
Tripp Harwell
Cory J. Pickett, BSN, RN, COA, OSC
Sloan W. Rush, MD, ABO
Purpose
To report satisfaction results among patients using autologous serum (AS) for the treatment of various ocular surface disorders.
Methods
The charts of 56 consecutive patients that were treated with AS for chronic ocular surface disease were reviewed. These patients were surveyed by phone interview to evaluate their experience with the treatment. The main patient reported outcome measurements included the number of coexisting treatments that were able to be discontinued due to the benefits of AS and the presence or absence of adverse events associated with the treatment. Secondary outcome variables included patient’s stated percentage improvement and the average cost for the treatment. Outcome comparisons were also made based upon underlying ocular surface pathology.
Results
A total of 32 patients participated in the study: 20 were being treated for dry eye disease (DED) and 12 were being treated for neurotrophic keratitis (NK). The average number of treatments was decreased by 3.4 (+/-1.6). Mean percentage improvement with AS was 50.5% (+/-30.2%) and two study subjects specified adverse effects linked with treatment, vision loss for both. There were 28 respondents that indicated that it worked well, however, only 16 said that they would want to do it again if given the opportunity. The average monthly out of pocket expense for the patient was $97.3(+/-$67.8) USD. There were no significant differences among the DED versus the NK groups (p>0.05 for all).
Conclusion
Autologous serum can be used with a high degree of patient satisfaction while reducing the number of simultaneous treatments that the patient must use to achieve ocular surface stability. Difficulty to access, necessity for frequent blood draws and relatively high cost are significant barriers for patient desirability for this treatment modality.
To Determine the Effect of Insulin on Persistent Epithelial Cornea Defects.
Authors
Odette A. Guzman, MD
Linnette Arzeno, MD
Joaquin Lora-Hernandez, MD
Angie De La Mota Sr., MD
Maria T. Salazar, MD
Nelsy M. Fernandez, MD
Miguel A. Lopez, MD
Purpose
To determine the effect of insulin on persistent epithelial cornea defects
Methods
Prospective, interventional and cross-sectional case series in patients diagnosed with persistent corneal erosions at Cornea and Refractive Surgery department from Dr. Elias Santana Hospital. Such cases became a sampling with eight eyes treated with topical insulin (1 ml of NPH insulin / 10 ml of propylene glycol / polyethylene glycol) three times a day.
Results
Sixty-two percent (62%) of the patients belonged to male gender, with no preference neither age group or baseline diagnoses. Sjogren's Syndrome and post-fungal keratitis defects stood out in 25% within the group. Pachymetric changes resulted in an average increase of 26.7% and 50% in the complete closure of the defect during the first 7 days, showing a tolerance of 100% without side adverse events reported.
Conclusion
Topical insulin is able to restore re-epithelialization and corneal healing in the absence of adverse effects
Odette A. Guzman, MD
Linnette Arzeno, MD
Joaquin Lora-Hernandez, MD
Angie De La Mota Sr., MD
Maria T. Salazar, MD
Nelsy M. Fernandez, MD
Miguel A. Lopez, MD
Purpose
To determine the effect of insulin on persistent epithelial cornea defects
Methods
Prospective, interventional and cross-sectional case series in patients diagnosed with persistent corneal erosions at Cornea and Refractive Surgery department from Dr. Elias Santana Hospital. Such cases became a sampling with eight eyes treated with topical insulin (1 ml of NPH insulin / 10 ml of propylene glycol / polyethylene glycol) three times a day.
Results
Sixty-two percent (62%) of the patients belonged to male gender, with no preference neither age group or baseline diagnoses. Sjogren's Syndrome and post-fungal keratitis defects stood out in 25% within the group. Pachymetric changes resulted in an average increase of 26.7% and 50% in the complete closure of the defect during the first 7 days, showing a tolerance of 100% without side adverse events reported.
Conclusion
Topical insulin is able to restore re-epithelialization and corneal healing in the absence of adverse effects
Early Real-World Results of Topical Cenegermin for the Treatment of Neurotrophic Keratitis
Authors
Amar P. Shah, MD, MBA
Matthew R. Denny, MD
Albert Y. Cheung, MD, ABO
Kasey L. Pierson, MD
John D. Sheppard, MD, FACS
Michael Nordlund, MD
Elizabeth Yeu, MD
Edward J. Holland, MD
Purpose
Our study aims to evaluate the safety and efficacy of topical Cenegermin, or recombinant human growth factor, in the treatment of neurotrophic keratitis associated with non-healing epithelial defects.
Methods
A single center retrospective chart review was conducted on 47 patients with neurotrophic keratitis treated with eight weeks of topical Cenegermin six times daily. Inclusion criteria included patients with objectively absent or markedly diminished corneal sensation, regardless of etiology. The primary end point was healing of corneal epithelial defect after completion of therapy. Secondary efficacy end points included improvement in visual acuity, change in corneal sensation, recurrence of epithelial defect, and need for bandage contact lens after completion of therapy. Secondary safety end points included presence of brow ache and pain with drop instillation during the treatment period.
Results
Fifty-seven eyes in 53 patients completed treatment and follow up. Of 35 eyes with documented pre- and post-treatment sensation, 27 (77%) had objective increase in corneal sensation. Forty-six eyes (81%) had no recurrence of epithelial defect (ED) at 24 weeks. Of 19 eyes with a pre-treatment ED, only 4 had a persistent ED post-treatment. In all 4 eyes, the defect decreased in size from baseline. Twenty-eight eyes (49%) improved in visual acuity (VA), compared to 23 (40%) with no change and 6 (11%) with worse VA. Of 24 eyes in a bandage contact lens (BCL) pre-treatment, 10 (42%) achieved BCL independence. Zero of 16 eyes with a pre-treatment tarsorrhaphy had their tarsorrhaphy removed.
Conclusion
Cenegermin treatment for neurotrophic keratitis subjects demonstrates favorable objective improvement in corneal sensation, visual acuity, and stability of the corneal epithelium, particularly in patients with a persistent epithelial defect or are bandage contact lens dependent.
Amar P. Shah, MD, MBA
Matthew R. Denny, MD
Albert Y. Cheung, MD, ABO
Kasey L. Pierson, MD
John D. Sheppard, MD, FACS
Michael Nordlund, MD
Elizabeth Yeu, MD
Edward J. Holland, MD
Purpose
Our study aims to evaluate the safety and efficacy of topical Cenegermin, or recombinant human growth factor, in the treatment of neurotrophic keratitis associated with non-healing epithelial defects.
Methods
A single center retrospective chart review was conducted on 47 patients with neurotrophic keratitis treated with eight weeks of topical Cenegermin six times daily. Inclusion criteria included patients with objectively absent or markedly diminished corneal sensation, regardless of etiology. The primary end point was healing of corneal epithelial defect after completion of therapy. Secondary efficacy end points included improvement in visual acuity, change in corneal sensation, recurrence of epithelial defect, and need for bandage contact lens after completion of therapy. Secondary safety end points included presence of brow ache and pain with drop instillation during the treatment period.
Results
Fifty-seven eyes in 53 patients completed treatment and follow up. Of 35 eyes with documented pre- and post-treatment sensation, 27 (77%) had objective increase in corneal sensation. Forty-six eyes (81%) had no recurrence of epithelial defect (ED) at 24 weeks. Of 19 eyes with a pre-treatment ED, only 4 had a persistent ED post-treatment. In all 4 eyes, the defect decreased in size from baseline. Twenty-eight eyes (49%) improved in visual acuity (VA), compared to 23 (40%) with no change and 6 (11%) with worse VA. Of 24 eyes in a bandage contact lens (BCL) pre-treatment, 10 (42%) achieved BCL independence. Zero of 16 eyes with a pre-treatment tarsorrhaphy had their tarsorrhaphy removed.
Conclusion
Cenegermin treatment for neurotrophic keratitis subjects demonstrates favorable objective improvement in corneal sensation, visual acuity, and stability of the corneal epithelium, particularly in patients with a persistent epithelial defect or are bandage contact lens dependent.
A Novel, Targeted, Open Eye, Thermal Therapy and Meibomian Gland Clearance in Treatment of Dye Eye: A Randomized Control Trial (OLYMPIA)
Authors
Jennifer M. Loh, MD, ABO
William B. Trattler, MD, ABO
Kavita P. Dhamdhere, MD, PhD
Marc R. Bloomenstein, OD
John A. Hovanesian, MD
Mitchell A. Jackson, MD, ABO
Bobby Saenz, OD
Methods
A total of 142 patients with signs and symptoms of DED were enrolled in prospective, single-masked, controlled, multi-center trial and randomized 1:1 to a single treatment with either of two devices. Key eligibility criteria were regular use of artificial tears or lubricants, Ocular Surface Disease Index (OSDI) score between 23 and 79, Meibomian gland score (MGS) ≤12 and TBUT of ≤7. Pre and post treatment TBUT, MGS, and corneal and conjunctival staining (CCS), Eye Dryness Scores (EDS), OSDI, SANDE were collected at Day1, Week2, and Month1. Adverse events (AE) were recorded for safety. Non-inferiority of change from baseline in TearCare (TC) group was compared to LipiFlow (LF) at Month1.
Results
Significant improvements in mean TBUT and MGS in both groups was seen, 3.0±2.2 and 12.1±9.8 in the TC group and 2.4±3.0 and 11.3±8.6 in the LF group (P<.0001). Significant decrease in CCS and in symptoms (P<.001) was seen in both groups. The mean EDS, SANDE and OSDI was reduced by 35.1±26.8, 37.2±26.7, 27.8±20.6. and 36.4±28.8, 40.2±26.4, 23.6±17.7 respectively in the TC and in LF groups. The two groups did not show statistically detectable differences. However, the TC group showed better improvements in TBUT, MGS and OSDI. TC group had a higher proportion of patients (72%) improving at least by 1 OSDI category than the LF group (60%). No device related AEs were reported in either group.
Conclusion
A single treatment of TearCare® safely and successfully treats signs and symptoms of DED in patients with MGD. Non-inferiority objective was met compared to LipiFlow®. A greater proportion of patients in TearCare group showed better symptomatic relief compared to LipiFlow group assessed by OSDI questionnaire.
Jennifer M. Loh, MD, ABO
William B. Trattler, MD, ABO
Kavita P. Dhamdhere, MD, PhD
Marc R. Bloomenstein, OD
John A. Hovanesian, MD
Mitchell A. Jackson, MD, ABO
Bobby Saenz, OD
Methods
A total of 142 patients with signs and symptoms of DED were enrolled in prospective, single-masked, controlled, multi-center trial and randomized 1:1 to a single treatment with either of two devices. Key eligibility criteria were regular use of artificial tears or lubricants, Ocular Surface Disease Index (OSDI) score between 23 and 79, Meibomian gland score (MGS) ≤12 and TBUT of ≤7. Pre and post treatment TBUT, MGS, and corneal and conjunctival staining (CCS), Eye Dryness Scores (EDS), OSDI, SANDE were collected at Day1, Week2, and Month1. Adverse events (AE) were recorded for safety. Non-inferiority of change from baseline in TearCare (TC) group was compared to LipiFlow (LF) at Month1.
Results
Significant improvements in mean TBUT and MGS in both groups was seen, 3.0±2.2 and 12.1±9.8 in the TC group and 2.4±3.0 and 11.3±8.6 in the LF group (P<.0001). Significant decrease in CCS and in symptoms (P<.001) was seen in both groups. The mean EDS, SANDE and OSDI was reduced by 35.1±26.8, 37.2±26.7, 27.8±20.6. and 36.4±28.8, 40.2±26.4, 23.6±17.7 respectively in the TC and in LF groups. The two groups did not show statistically detectable differences. However, the TC group showed better improvements in TBUT, MGS and OSDI. TC group had a higher proportion of patients (72%) improving at least by 1 OSDI category than the LF group (60%). No device related AEs were reported in either group.
Conclusion
A single treatment of TearCare® safely and successfully treats signs and symptoms of DED in patients with MGD. Non-inferiority objective was met compared to LipiFlow®. A greater proportion of patients in TearCare group showed better symptomatic relief compared to LipiFlow group assessed by OSDI questionnaire.
Blephex Assisted Obstructive Meibomian Gland Dysfunction Treatment (No Audio)
Author
Hamidreza Hasani, MD, MSc
Methods
In this retrospective study, 312 lids of 78 patients (49 female and 29 male) with symptomatic MGD blepharitis were enrolled, whom treated with BlephEx (Scope Ophthalmics Ltd., UK). Outcome measures were ocular symptoms taken prior to treatment and 1, 3 and 6 months after treatment using SPEED score and OSDI questionnaires. Dry eye disease was evaluated using tear break up time (TBUT). Ancillary treatments were unchanged pre and post treatment.
Results
The average SPEED score changed from 16.65 to 6.85 (58% decrease: P < 0.05). OSDI score was changed from 62.50 to 29.25 (53% decrease; P < 0.05). The average TBUT improved from 10.1 to 16.8 seconds (66% increase; P < 0.05). Two cases of severe blepharo-kerato-conjunctivitis significantly improved. No complication occurred.
Conclusion
BlephEx is an effective and safe treatment for management of obstructive meibomian gland dysfunction and dry eye syndrome.
Hamidreza Hasani, MD, MSc
Methods
In this retrospective study, 312 lids of 78 patients (49 female and 29 male) with symptomatic MGD blepharitis were enrolled, whom treated with BlephEx (Scope Ophthalmics Ltd., UK). Outcome measures were ocular symptoms taken prior to treatment and 1, 3 and 6 months after treatment using SPEED score and OSDI questionnaires. Dry eye disease was evaluated using tear break up time (TBUT). Ancillary treatments were unchanged pre and post treatment.
Results
The average SPEED score changed from 16.65 to 6.85 (58% decrease: P < 0.05). OSDI score was changed from 62.50 to 29.25 (53% decrease; P < 0.05). The average TBUT improved from 10.1 to 16.8 seconds (66% increase; P < 0.05). Two cases of severe blepharo-kerato-conjunctivitis significantly improved. No complication occurred.
Conclusion
BlephEx is an effective and safe treatment for management of obstructive meibomian gland dysfunction and dry eye syndrome.
Pterygium Surgery in the Laser Suite
Author
Michelle K. Rhee, MD
Purpose
To describe the performance of pterygium excision with conjunctival autograft and fibrin glue in an excimer laser suite setting.
Methods
A retrospective chart review of pterygium surgeries performed by one surgeon in one laser center during 2017 were analyzed for adverse events including infection and recurrence. A description of the procedure and pearls for transitioning pterygium surgery to the excimer laser microscope setting will be shared.
Results
133 pterygium surgeries were performed in 2017. 52.6% had at least 3 months of followup (3-<6 months 18.0%; 6-<12 months 13.5%; 1 year and more 21.1%). No infection, graft loss, or recurrence occurred. 13.5% of cases developed ocular hypertension postoperatively.
Conclusion
Pterygia are commonly removed prior to either excimer laser or cataract surgery. The VISX laser's microscope and room standards meet the requirements of a minor room. With a technician and diazepam, pterygium excision can be performed safely and comfortably in the laser suite, providing time and cost- savings to the patient, surgeon, and society.
Michelle K. Rhee, MD
Purpose
To describe the performance of pterygium excision with conjunctival autograft and fibrin glue in an excimer laser suite setting.
Methods
A retrospective chart review of pterygium surgeries performed by one surgeon in one laser center during 2017 were analyzed for adverse events including infection and recurrence. A description of the procedure and pearls for transitioning pterygium surgery to the excimer laser microscope setting will be shared.
Results
133 pterygium surgeries were performed in 2017. 52.6% had at least 3 months of followup (3-<6 months 18.0%; 6-<12 months 13.5%; 1 year and more 21.1%). No infection, graft loss, or recurrence occurred. 13.5% of cases developed ocular hypertension postoperatively.
Conclusion
Pterygia are commonly removed prior to either excimer laser or cataract surgery. The VISX laser's microscope and room standards meet the requirements of a minor room. With a technician and diazepam, pterygium excision can be performed safely and comfortably in the laser suite, providing time and cost- savings to the patient, surgeon, and society.
Predictive Factors of Successful Treatment of Meibomian Gland Dysfunction
Authors
Maria Laura Gomez, MD
Natalie A. Afshari, MD
Purpose
Little has been reported about predictive factors of patient’s favorable response to treatment of Meibomian Gland Dysfunction (MGD) with thermal pulsation or thermoelectrical warming therapy. The purpose of this study was to determine pre-treatment characteristics that predict patient’s success versus suboptimal response after MGD treatment.
Methods
This is a consecutive case series of 140 patients with MGD treated by a single physician using a standardized clinical evaluation and treatment algorithm. Autoimmune etiologies were excluded. At baseline, 2 and 12 months after MGD treatments, all patients underwent both SPEED and OSDI questionnaires, meibography, tear breakup time, MG evaluation and expressibility scores, partial blinking, lipid layer thickness, tear osmolarity, ocular surface staining and Schirmer’s testing. We analyzed the correlation of the underlying associated comorbidity with the patient’s dry eye discordance score. Multivariate analysis determined the best predictors for successful MGD thermal therapy.
Results
Despite improvement in 89% of the objective parameters: ocular staining, TBUT, tear osmolarity, MG quality and expressibility score, and in both objective SPEED (82%) and OSDI (88%) questionnaires, a subgroup of patients (10.7%) felt their symptoms persisted or had no improvement. Multivariate analysis showed conjunctival chalasis predicted 18% of patient perceived dissatisfaction, the presence of previous eyelid surgery accounted for 14% of dissatisfaction, nocturnal lagophthalmos for 12.95%, associated allergic component 12%, and non-compliance with at home regime accounted for 13.5%. (Regression analysis p<0.03)
Conclusion
Attention to the treatment of ocular co-morbidities is critical to the success of MGD treatments. Conjuntivochalasis, nocturnal lagophthalmos, persistent partial blinking, and eyelid surgeries account for patient’s subjective persistence of dry eye symptoms and account for suboptimal results despite improvement in objective parameters.
Maria Laura Gomez, MD
Natalie A. Afshari, MD
Purpose
Little has been reported about predictive factors of patient’s favorable response to treatment of Meibomian Gland Dysfunction (MGD) with thermal pulsation or thermoelectrical warming therapy. The purpose of this study was to determine pre-treatment characteristics that predict patient’s success versus suboptimal response after MGD treatment.
Methods
This is a consecutive case series of 140 patients with MGD treated by a single physician using a standardized clinical evaluation and treatment algorithm. Autoimmune etiologies were excluded. At baseline, 2 and 12 months after MGD treatments, all patients underwent both SPEED and OSDI questionnaires, meibography, tear breakup time, MG evaluation and expressibility scores, partial blinking, lipid layer thickness, tear osmolarity, ocular surface staining and Schirmer’s testing. We analyzed the correlation of the underlying associated comorbidity with the patient’s dry eye discordance score. Multivariate analysis determined the best predictors for successful MGD thermal therapy.
Results
Despite improvement in 89% of the objective parameters: ocular staining, TBUT, tear osmolarity, MG quality and expressibility score, and in both objective SPEED (82%) and OSDI (88%) questionnaires, a subgroup of patients (10.7%) felt their symptoms persisted or had no improvement. Multivariate analysis showed conjunctival chalasis predicted 18% of patient perceived dissatisfaction, the presence of previous eyelid surgery accounted for 14% of dissatisfaction, nocturnal lagophthalmos for 12.95%, associated allergic component 12%, and non-compliance with at home regime accounted for 13.5%. (Regression analysis p<0.03)
Conclusion
Attention to the treatment of ocular co-morbidities is critical to the success of MGD treatments. Conjuntivochalasis, nocturnal lagophthalmos, persistent partial blinking, and eyelid surgeries account for patient’s subjective persistence of dry eye symptoms and account for suboptimal results despite improvement in objective parameters.