Moderator
Michelle K. Rhee, MD, ABO
Panelists
Alice T. Epitropoulos, MD, FACS, ABO
Helen K. Wu, MD, ABO
Viewing Papers
Expand a paper title to the right to view the paper abstract and authors. Use the video link to jump to that poster in the session.
Presenting Author
Justin Riffel, MD
Co-Authors
Siri Yalamanchili MD, Albert Cheung MD, Edward Holland MD
Purpose
The purpose of this study is to determine at what age patients with congenital aniridia lose central vision in concert with lifetime trends in aniridic keratopathy (AK).
Methods
This retrospective chart review studied patients with congenital aniridia who have been treated at a single facility from 1999-2024. Outcome measures included patient presenting age versus AK stage, which was defined as 0-5, where stage 3 denotes involvement of the central cornea. Visual acuity (VA) at presentation and the patient�s best historical VA, or lifetime best-ever (LBE) VA was correlated with presenting AK stage.
Results
There were 406 eyes from 212 patients (59.0% female) included with a mean follow-up of 8.04 years (range 0-24.5). Mean age at presentation was 31.9 years with a mean presenting VA of 20/305 (logMAR 1.184). 69.5% of eyes presented with stage 3-5 AK, at a mean age of 34.0 years compared to 23.7 years for those with stage 0-2 AK (p<0.05). of="" the="" 139="" eyes="" with="" lbe="" va="" recorded,="" 23.0%="" presented="" with="" stage="" 0-2="" ak="" (mean="" age="" 27.2="" years),="" and="" their="" va="" worsened="" from="" lbe="" 20/60="" to="" 20/85="" at="" presentation=""><0.05); of="" the="" 139="" eyes="" with="" lbe="" va="" recorded,="" 72.7%="" presented="" with="" stage="" 3-5="" ak="" (mean="" age="" 35.1="" years,="" p="0.024)," and="" their="" va="" worsened="" from="" lbe="" 20/129="" to="" 20/589="" at="" presentation="">< />
Conclusion
Patients with congenital aniridia lose their central vision by their early fourth decade, leading to subspecialty referral. Aniridic keratopathy appears to be a primary etiology of vision loss given its involvement of the central cornea by this time, most often stage 3 or higher.
Presenting Author
Siddharth Nath, MD, PhD
Co-Authors
Julia Talajic FRCSC, MD, Allison Bernstein MD, Johanna Choremis MD, FRCSC, Claudine Courey OD, MSc, Jia Yue You FRCSC, MD, Jack Mouhanna MD, Gabriella Courey OD, MSc, Marie-Mich�le Dupuis MSc, OD
Presenting Author
Nader Nassiri, MD
Co-Authors
Kourosh Sheibani MD, MSc, Sara Kavousnezhad BSc
Purpose
To compare histologic abnormalities of tear film and tear osmolarity between normal eyes and eyes with pterygium.
Methods
This was a prospective, hospital-based, case�control study involving 95 patients (65 men, 30 women) with unilateral pterygium. The tear meniscus height (TMH), Schirmer's test-1 (SCH-1) score, Rose Bengal staining (RBS) score, tear film breakup time (TBUT), tear osmolarity (TO), and conjunctival impression cytology (CIC) were assessed in both eyes. The Chi-square and Student's t-tests were used to compare the results between the two groups. P values <0.05 were="" considered="" statistically="">
Results
The mean patient age was 50.9 years, with the largest age group being the 45�55 year-old bracket across both genders. Most patients (82.1%) had nasal pterygium, and 80% were involved in outside activities. The mean assessment values in the case and control groups were as follows: TMH, 0.21 vs. 0.24 mm; SCH-1, 13.2 vs. 17.8 mm; RBS, 4.38 vs. 2.51 points; TBUT, 8.7 vs. 13.2 seconds; TO, 306 vs. 299 mOsm/L (P < 0.001="" in="" all="" cases).="" the="" proportions="" of="" abnormal="" assessment="" values="" in="" the="" case="" and="" control="" groups="" were="" as="" follows:="" tmh,="" 82.1%="" vs.="" 3.16%;="" sch-1,="" 20%="" vs.="" 2.1%;="" rbs,="" 30.53%="" vs.="" 4.22%;="" tbut,="" 61.05%="" vs.="" 6.3%;="" to,="" 10.52%="" vs.="" 1.05%;="" cic,="" 33.7%="" vs.="" 7.37%="" (p="" />< 0.05="" for="" all="" />
Conclusion
This study showed that the quantity and quality of tear film, as well as the number of goblet cells, decreased, but the tear osmolarity increased in eyes with pterygium. Furthermore, the TMH, RBS results, TBUT, and CIC have more precise state of the patient's tear condition with the disease of the pterygium.
Presenting Author
Rushad C. Shroff, MS
Co-Authors
Apoorva Agrawal DNB
Purpose
Dry eye disease (DED) is characterized by loss of tear film homeostasis and a lack of association between signs and symptoms. The purpose of this study is to use a novel non-invasive artificial intelligence based imaging and app based treatment modality to alter subjective symptoms and objective tear metrics in evaporative dry eye patients.
Methods
It was a prospective interventional study of subjects with evaporative dry eye disease (EDE) defined as subjects with symptoms of dry eye and fluorescein break up time (TBUT) less than 10 seconds. The sample size was 50 subjects. All subjects underwent baseline dry eye evaluation including lipid layer thickness, Non contact TBUT, FBUT, Schirmer's, Meniscus height and variability in ocular surface temperature using the Ocular surface imager. The OSDI questionnaire was administered to all subjects. Our novel smartphone and computer screen app was installed to monitor and remind subjects to blink and follow the 20-20-20 rule. All tests were repeated at 1 and 3 months after using the app.
Results
There was a significant change (p=0.03) in TBUT from baseline (7 + 0.87) seconds to one month after the app based intervention(11 +0.78). The lipid layer thickness significantly increased (p=0.002) from (54 + 10)nm to (72 +11)nm after the intervention. There was a significant reduction in OSDI scores (p=0.04) from (24 +4) to (10 +5) after using the app. There was a trend towards less fluctuation in ocular surface temperature though this did not achieve statistical significance. There was no significant change in the Schirmers values, Meibo score or Aberrations.
Conclusion
The use of this novel and simple imaging based app may help patients practice better blink hygiene. This may lead to improvement in tear film metrics and subjective symptoms in patients with EDE. Further studies and a larger sample size are required to verify the same
Presenting Author
Caberry W. Yu, MD
Co-Authors
Mohamed Gemae BSc, Nikhil Patil MD, Manokamna Agarwal MD, Allan Slomovic MSc, MD, FRCS, Clara Chan MD, FRCSC
Purpose
Ocular surface disorders (OSDs) can significantly affect vision and quality of life. Recently, autologous blood products, including platelet-rich in growth factor (PRGF), have become available to treat OSDs refractory to conventional therapies. This review aims to summarize the efficacy and safety of PRGF in managing OSDs.
Methods
This review adhered to the PRISMA guidelines for systematic reviews and meta-analyses. The protocol was established a priori and published on PROSPERO (CRD42024522119). A comprehensive search was conducted on Medline, Embase, and Cochrane Library for primary articles until February 6th, 2024. The primary outcomes evaluated included slit lamp examination findings and patient-reported outcomes. Secondary outcomes included visual outcomes, and adverse events. Risk of bias was assessed using the Cochrane Risk of Bias and ROBINS-I tools.
Results
Twenty-two studies encompassing 1,158 eyes were included. PRGF demonstrated notable improvements in both objective and subjective outcomes for OSDs. Comparative studies indicated that PRGF was not superior to a standard steroid taper for treating dry eye disease. However, PRGF was also utilized for persistent epithelial defects and corneal ulcerations, showing high rates of complete healing (up to 96.2% of eyes) and reduced corneal staining, with an average time-to-healing of 11.5 � 12.5 weeks. PRGF has also been reported to improve ocular surface healing and stability when used as an adjunct to refractive and pterygium surgeries. No serious adverse events were reported.
Conclusion
PRGF shows promise as an effective treatment for OSDs that are resistant to conventional therapies, with minimal safety concerns. However, most of the included studies were retrospective and non-comparative. Thus, large, randomized-controlled trials are necessary to more accurately determine the role of PRGF in treating corneal pathologies.
Presenting Author
Jitender Jitender, MBBS, MS
Co-Authors
Anjali Anjali MBBS, Amit Gupta MS, Arun Jain MD, Chintan Malhotra MS
Purpose
A comparative evaluation of Meibomian Gland (MG) Dysfunction and Dry Eye Disease (DED) in patients of Mucous Membrane Pemphigoid (MMP) with and without obvious ocular complaints with their age matched controls.
Methods
A prospective, cross-sectional study, was carried out in department of Ophthalmology between January, 2023 to March, 2024. Patients were recruited into three groups: Group 1- MMP with obvious eye complaints; Group 2 - MMP without obvious eye complaints who were under treatment in the Autoimmune Bullous Disease clinic of the Department of Dermatology; Group 3- healthy age match controls for Group 1 & 2. Demographic details were noted, DED work up was done and Meibography was performed using an infrared analyzer. MG dropout area (MGDA) was scored by using meibography images and grade of MGDA was recorded.
Results
Total 123 eyes of 64 subjects were included, 35 eyes in group1, 24 eyes in group 2 and 64 eyes in group 3. Mean OSDI (ocular surface disease index) score in group 1 (35.29 � 14.03) was higher than group 2 (16.71 � 5.76) and group 3 (17.34 � 12.23) (P=0.0001). Severe grade MGDA was most frequently found in ocular group 1 (78.5%), followed by group 2 (21.4%) and control group (0%). Significant difference was noted in MGDA between group 1 vs. group 2 (p=0.003), as well as group 1 and group 2 vs. control group (P=0.0001).
Conclusion
To best of our knowledge, this is first study to objectively demonstrate MG damage in MMP patients and also brings to light evidence of subclinical ocular disease activity in MMP patients who doesn't have ocular complaints. Regular ophthalmological examination and meibography of non-ocular MMP patients is advisable to detect early eye involvement.
Presenting Author
Myung-Sun Song, MD, MS
Co-Authors
Dong Hyun Kim PhD, MD, Nayoon Park BA, Yun-Hee Choi PhD, Shiva Raj Acharya PhD, Yoon-Hyeong Choi PhD
Purpose
Particulate matter (PM) is known to exert detrimental effects on ocular surface health and be associated with dry eye disease (DED). We investigated the short- and medium-term adverse effects of multiple air pollutants in patients with DED.
Methods
A multicenter prospective cohort study was conducted on 74 patients with DED from four tertiary hospitals in South Korea. Tear break-up time (TBUT), Symptom Assessment in Dry Eye (SANDE) score, Schirmer�s test, and corneal staining score (CSS) were assessed at each visit. The associations between DED parameters and exposure to air pollutants (PM2.5, PM10, SO2, and NO2) for 3 days, 1 week, and 1 month before the ocular examination were analyzed using generalized linear mixed models. In addition, the association of 8-oxo-2'-deoxyguanosine (8-oxo-dG) with DED and air pollutants was also analyzed with mediation analyses.
Results
In the multi-pollutant model, SO2 and NO2 exposures were negatively correlated with TBUT [SO2: ?=-0.069/-0.043/-0.075, p=0.008/0.012/0.019; NO2: ?=-0.057/-0.071/-0.220, p=0.016/0.002/0.005 (3 days/ 1 week/ 1 month)]. NO2 also showed a negative correlation with tear secretion at 1-month exposure (?=-0.297, p=0.048). PM2.5 and PM10 showed no significant changes in DED parameters compared to SO2 and NO2. 8-oxo-dG significantly indirectly mediated the relationship between SO2 and DED parameters at 3 days exposure [SANDE: ?=3.821/2.148, TBUT: ?=-0.231/-0.115 (total/indirect effect), each p < />
Conclusion
Exposure to SO2 and NO2 showed significant short- and medium-term adverse effects on DED compared to PM in a multi-pollutant model. To understand the adverse effects of air pollution on DED, we should consider several air pollutants, not just PM.
Presenting Author
Laura M. Periman, MD, ABO
Co-Authors
Guruprasad Pattar MD, PhD, Eugene McLaurin FACS, MD, Michelle Boyce MD, Alex Liu MD, Michelle Senchyna PhD
Purpose
In 2 Ph3 studies (COMET-2 [C2], COMET-3 [C3]), treatment with acoltremon 0.003% (ACO) led to significant increase in tear production. Symptoms of dry eye disease (DED) were also significantly reduced in favor of ACO in C2 and directionally in favor of ACO in C3. The purpose of this study was to further investigate the impact of ACO on DED symptoms.
Methods
Both studies (N=460/study) included subjects aged ?30 years with DED signs and symptoms of prespecified levels. Qualified subjects at screening received vehicle (VEH) in both eyes (OU) BID for 14 days. At baseline, subjects were randomized 1:1 to receive ACO or VEH, administered BID OU for 90 days. Symptoms were assessed with the Symptom Assessment Questionnaire iN Dry Eye (SANDE; 0-100). The percent of subjects achieving ?30% improvement from baseline in SANDE score (a suggested minimal clinically important difference [MCID]) in each study as well as a pooled analysis of C2 and C3 were analyzed by the Pearson chi-squared test and the Cochran-Mantel-Haenszel test.
Results
In both studies, the proportion of subjects receiving ACO vs VEH who achieved ?30% improvement from baseline in SANDE score increased at each visit. Over the first 28 days, response rates were day (D) 7: C2, 20.3% vs 16.8%, and C3, 25.1% vs 21.7%; D14: C2, 34.5% vs 25.7%, P=0.0421, and C3, 37.6% vs 26.8%, P=0.0142; and D28: C2, 39.0% vs 31.7%, and C3, 42.0% vs 34.1%. In the pooled analysis, meaningful proportion differences in favor of ACO vs VEH were observed at D14 (9.8% [36.1% vs 26.2%]; P=0.0015) and D28 (7.6% [40.5% vs 32.9%]; P=0.0184).
Conclusion
In the individual and pooled studies, rapid, consistent, and clinically relevant DED symptom improvement was observed, with an overall 40.5% of ACO-treated subjects attaining the suggested MCID in SANDE score change from baseline within 1 month. These data further support ACO as a potential new treatment for the signs and symptoms of DED.
Presenting Author
Pedram Hamrah, MD
Co-Authors
Victor Sendra PhD, Flavia Barbosa PhD, Deshea Harris MS
Purpose
Lifitegrast ophthalmic solution 5% (Xiidra), a leukocyte function-associated antigen-1 (LFA-1) antagonist, is indicated for treatment of signs and symptoms of dry eye disease (DED). This study assessed how lifitegrast reduces CD4+ T cell migration to the cornea and mediates T cell alterations in draining lymph nodes (dLNs) in a murine model of DED.
Methods
DED was induced in 6�8-week-old mice by exposure to the controlled environmental chamber and subcutaneous injections of scopolamine. Mice were treated with topical lifitegrast (or normal saline [NS]) 3 times daily. DED severity was assessed with corneal fluorescein score (CFS) and T cells were quantified by flow cytometry (FC) of corneal single cell suspensions. Expression of chemokine receptors on T cells from submandibular dLNs was assessed by FC and RT-PCR. T cells from DED mice treated with lifitegrast or NS were sorted and adoptively transferred to RAG knockout mice, and DED severity and T cells (in pooled corneas and dLNs) were assessed after 5 days.
Results
CFS was significantly reduced and tear secretion was significantly improved after 15 days of lifitegrast versus NS treatment in DED mice (P<0.05). compared="" with="" ns="" treatment,="" lifitegrast="" treatment="" resulted="" in="" reduction="" of="" ifn?="" secreting="" cd4+="" t="" cell="" (th1)="" recruitment="" to="" the="" cornea="" and="" significant="" reductions="" in="" cxcr3="" and="" ccr4="" chemokine="" receptor="" expression="" by="" fc="" and="" cxcr3="" mrna="" levels="" in="" cd4+="" t="" cells="" from="" dlns=""><0.05). adoptively="" transferred="" cd4+="" t="" cells="" from="" lifitegrast-treated="" versus="" ns-treated="" ded="" mice="" to="" rag="" knockout="" mice="" resulted="" in="" significant="" reduction="" of="" cfs=""><0.05) and="" 60%="" reduction="" in="" cd4+="" t="" cell="" recruitment="" into="" cornea,="" with="" no="" change="" in="" recruitment="" in="">
Conclusion
These results demonstrate that topical application of lifitegrast has an effect beyond the ocular surface, directly on dLNs, and show that topical drug application impacts the efferent arm of immunity as well.
Presenting Author
Preeya K. Gupta, MD
Co-Authors
James Paauw MD, Mitchell Shultz MD, Nancy Cline MD, Lee Katzman MD, Michelle Senchyna PhD
Purpose
Damage or dryness of the ocular surface is a hallmark sign of dry eye disease (DED). In Ph3 studies, treatment with acoltremon 0.003% (ACO), a TRPM8 agonist, was associated with a rapid increase in tear production, which was sustained in a large proportion of subjects. This study investigates the impact of ACO on total ocular staining.
Methods
COMET-2 (C2) and COMET-3 (C3) were identical Ph3 studies that enrolled subjects aged ?30 years with signs and symptoms of DED of prespecified levels. Qualified subjects were randomized 1:1 to receive ACO or vehicle (VEH) BID in both eyes for 90 days. Corneal and conjunctival staining were individually assessed and graded using the modified NEI scale, with sodium fluorescein (mNEI: 0-20) and lissamine green (mNEI: 0-24), respectively. Total ocular staining (tOS; mNEI 0-44) was derived from the sum of total corneal and conjunctival staining, and change from baseline (CFB) tOS scores at each visit were analyzed by ANCOVA. Safety assessments were performed at all visits.
Results
Enrollment in C2 and C3 was 465 and 467 subjects, respectively. Reductions from baseline in tOS as early as day (D) 7 were observed in favor of ACO vs VEH in both the individual studies as well as in a pooled analysis (PA) (LS mean CFB � SE �3.35 � 0.34 vs �2.57 � 0.33, P=0.0697 [C2]; �3.86 � 0.36 vs �2.13 � 0.36, P=0.0002 [C3]; �3.39 � 0.23 vs �2.12 � 0.23, P<0.0001 [PA]) and through D90 (LS mean CFB � SE �4.43 � 0.36 vs �3.13 � 0.36, P=0.0052 [C2]; �4.75 � 0.39 vs �2.3 � 0.39, P<0.0001 [C3]; �4.01 � 0.26 vs �2.10 � 0.25, P<0.0001 [PA]). The only ocular adverse event with incidence of >2.5% was instillation site burning or stinging, which was rated as mild in the majority of cases.
Conclusion
In the individual and pooled Ph3 studies, ACO led to rapid and sustained reductions in total ocular staining, a classic sign of ocular surface damage. Such improvement along with the observed persistent tear production as stimulated by ACO supports the potential of ACO as a new treatment option for the signs and symptoms of DED.
Presenting Author
Laura M. Periman, MD, ABO
Purpose
Incomplete blinking is a significant contributor to dry eye signs and symptoms. It is possible that treatment with dynamic muscle stimulation and radiofrequency will improve completeness of blink and improve signs and symptoms of ocular surface disease.
Methods
Twelve patients with incomplete blinking and improvement in excess downward facial vectors with a midface support maneuver were treated from 1 to 4 times with combination dynamic muscle stimulation and radiofrequency with or without botox by Cotofana protocol. 60 seconds of typical blinking was recorded in each eye and their incomplete blink frequency and severity was recorded before and after each treatment.
Results
Specific results to be completed. All patients showed improvements in percentage of incomplete blinks following each treatment, at time of abstract writing 2 of 12 subjects improved to 0% incomplete blink following four treatments. In more severe cases, improvement in severity of incomplete blink was noted.
Conclusion
Combination dynamic muscle stimulation and radiofrequency treatment was effective in improving frequency and severity of incomplete blinks.
Presenting Author
Jason Bacharach, MD
Co-Authors
Shane Kannarr OD, Anthony Verachtert OD, Moataz Razeen MD, Jason Vittitow PhD, Jacob Lang OD
Purpose
Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This study evaluated patient perceptions and satisfaction early in treatment with PFHO.
Methods
This prospective, multicenter, open-label, phase 4 study (NCT06309953) enrolled adults with history of DED for ?6 months, tear film breakup time (TFBUT) ?5 sec, Schirmer I test (without anesthesia) score ?5 mm, Meibomian gland dysfunction (MGD) score ?3 (range, 0-15), and total corneal fluorescein staining (tCFS) score ?4 and ?11 (range, 0-15). PFHO was instilled in both eyes QID for 14 days. Patients completed early outcome surveys on days 1 (baseline), 3, 7, and 14 clinic visits, which assessed DED symptom severity (overall and 8 symptoms) and treatment satisfaction (visual analog scale [0-100]). Primary endpoint was mean change from baseline (CFB) in overall DED symptom severity at Day 7.
Results
99 patients were enrolled (mean age, 61.3 years; 85.9% females). At baseline, mean scores (both eyes) were: TFBUT, 3.6 sec; Schirmer I test, 14.2 mm; MGD score, 8.3; and tCFS, 5.2. Mean CFB in overall DED symptom severity was statistically significant at Day 7 (baseline: 72.1; Day 7: 27.8; CFB: -44.5 [61.7% reduction]; P<0.0001) and="" at="" all="" follow-up="" visits=""><0.0001). mean="" cfb="" was="" also="" statistically="" significant=""><0.0001) at="" all="" follow-up="" times="" for="" severity="" of="" all="" 8="" symptoms="" (eye="" dryness,="" burning/stinging,="" eye="" itching,="" light="" sensitivity,="" eye="" pain,="" eye="" tiredness,="" eye="" irritation,="" and="" blurred="" vision).="" median="" rating="" of="" treatment="" satisfaction="" was="" 83.0="" at="" day="" 3,="" 86.0="" at="" day="" 7,="" and="" 90.0="" at="" day="">
Conclusion
Early in the course of treatment with PFHO, patients with DED experienced significant reductions in dry eye symptom severity. Treatment satisfaction with PFHO was high.
Presenting Author
Laura M Periman, MD, ABO
Co-Authors
Kenneth Kenyon MD, Blair Boehmer MD, Gail Torkildsen MD, Clark Springs MD, Michelle Senchyna PhD
Purpose
In 2 pivotal Ph3 studies (COMET-2 [C2] and COMET-3 [C3]), acoltremon 0.003% (ACO), a potent TRPM8 agonist, demonstrated clinically meaningful improvements in dry eye disease (DED) symptoms based on the Symptoms Assessment Questionnaire iN Dry Eye (SANDE). This study investigates the impact of ACO on improving DED symptoms assessed by other tools.
Methods
Eligibility criteria included age ?30 years with DED signs and symptoms of prespecified levels and a diagnosis within 6 months. Each study targeted a total enrollment of at least 460 subjects. Qualified subjects at screening received vehicle (VEH) in both eyes (OU) BID for 14 days. At baseline, subjects were randomized 1:1 to receive ACO or VEH, which was administered BID OU for 90 days. Symptom scores for eye dryness (EDS) and ocular discomfort (ODS) were assessed at all visits on an individual visual analog scale (VAS; 0-100 mm). Change from baseline in EDS-VAS and ODS-VAS were analyzed by ANCOVA.
Results
465 and 467 subjects were randomized in C2 and C3, respectively. As early as day (D) 7, notable improvements from baseline in EDS-VAS in favor of ACO vs VEH were observed in C2 (P=0.0065) and a pooled analysis (PA) of both studies (P=0.0335). For ODS-VAS, a notable treatment difference in favor of ACO was observed in the PA as early as D14 (P=0.0237). At D28, notable differences between treatment groups, in favor of ACO, were observed for both EDS-VAS (LS mean difference � SE �5.0 � 2.15, P=0.0188 [C2]; �4.4 � 2.24, P=0.0482 [C3]; �4.9 � 1.60, P=0.0021 [PA]) and ODS-VAS (LS mean difference � SE �5.7 � 2.52, P=0.0240 [C2]; �5.8 � 2.48, P=0.0205 [C3]; �5.8 � 1.78, P=0.0011 [PA]).
Conclusion
Improvements in 2 different measures of dry eye symptoms suggest improvement as early as after 14 days of ACO administration. These data complement and further support the consistent ability of ACO to rapidly improve DED symptoms and its potential as a new treatment option for the signs and symptoms of DED.
Presenting Author
Marguerite B. McDonald, MD, FACS
Co-Authors
David Wirta MD, Gregg Berdy MD, Megan Cavet PhD, Jason Vittitow PhD, John Sheppard MSc, MD
Purpose
Perfluorohexyloctane ophthalmic solution (PFHO; MIEBO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). This post hoc analysis assessed the efficacy of PFHO among patients with DED and cataract in the GOBI and MOJAVE pivotal studies.
Methods
GOBI and MOJAVE were phase 3, randomized, hypotonic saline�controlled, 8-week clinical studies evaluating the efficacy and safety of PFHO dosed four times a day in participants ?18 years with DED. Primary endpoints were change from baseline in total corneal fluorescein staining (tCFS) score (National Eye Institute scale, 0-15) and eye dryness visual analog scale (VAS) score (0-100). In this analysis, data for these endpoints were pooled and evaluated using an analysis of covariance among patients categorized into subgroups of patients with concomitant cataract and patients without cataract (or pseudophakia).
Results
Of 1217 patients overall (n=614 PFHO; n=603 saline), there were 411 patients with cataract and 667 without cataract. Consistent with overall population, reductions (ie, improvements) in tCFS and eye dryness scores were significantly greater for PFHO vs control in both subgroups. At Week 8, least-squares mean reductions from baseline in PFHO/control groups for tCFS were 1.9/0.9 (P=0.0003) for patients with cataract and 2.5/1.3 (P<0.0001) for="" patients="" without="" cataract,="" and="" for="" eye="" dryness="" were="" 28.0/19.3="" (p="0.0015)" for="" patients="" with="" cataract="" and="" 29.3/19.4=""><0.0001) for="" patients="" without="" cataract.="" similarly,="" improvements="" in="" tcfs="" and="" eye="" dryness="" scores="" were="" observed="" at="" week="">
Conclusion
PFHO was effective in improving signs and symptoms of DED in patients with DED and concomitant cataract. These data support that PFHO may be a promising treatment option for preoperative management of patients with DED undergoing cataract surgery, warranting further study in this patient population.
Presenting Author
Ralene Sim, MBBS, FRCOphth
Co-Authors
Hon Shing Ong MBBS, FRCSEd, MSc, FRCOphth
Purpose
Cicatrizing conjunctivitis (CC) can cause significant ocular morbidity. We aim to study the structure of collagen in CC to find sensitive and quantitative measures of severity of scarring as current progression of conjunctival scarring is reliant only on clinical assessment.
Methods
We used two-photon excitation (TPE) and second harmonic generation (SHG) to scan conjunctival tissues from patients with chronic CC and its relation to disease severity by correlation with a published validated clinical severity assessment tool. Conjunctival biopsies were taken and collagen morphometry in region of interest was analyzed with FibroIndex software (HistoIndex Pte Ltd.)
Results
18 patients (7 CC and 11 controls) were included. Mean age was 60.7 � 14.4 years old. Compared to controls, diseased group has significantly smaller collagen area ratio (CAR) (p<0.01), larger="" collagen="" fiber="" density="" (cfd)="" (p="0.03)" and="" smaller="" collagen="" fiber="" number="" (cfn)="" per="" mm2=""><0.01). in="" diseased="" groups,="" car="" significantly="" correlated="" with="" inflammation="" (r="-0.55," p="0.011)," scarring="" (r="0.61," p="0.0034)," morbidity="" (r="0.46," p="0.035)" and="" overall="" composite="" score="" (r="0.52," p="0.017)." in="" all="" groups,="" cfn="" per="" mm2="" negatively="" correlated="" with="" inflammation="" (r="-0.50,"><0.01), scarring="" (r="-0.25," p="0.07)" morbidity="" (r="-0.37,"><0.01) and="" overall="" composite="" score="" (r="-0.33," p="">
Conclusion
We have further characterized the defining features of scar development in CC. CAR has significant correlation to all scores in diseased groups and hence may be a reliable marker for diagnosis. CFN per mm2, as the only parameter with significant negative correlation with all scores, can potentially be a predictor for severity.
Presenting Author
Amar P. Shah, MD, MBA, ABO
Co-Authors
Andrew Barfell MD
Purpose
To identify the prevalence of hyperosmolar tear film in a pre-surgical (pre-Sx) cataract and 30-day post-surgical (post-Sx) patient population.
Methods
This was a prospective, observational cohort study at the Cincinnati Eye Institute, Cincinnati, Ohio. Subjects presenting for pre-Sx cataract evaluations were selected randomly. Tear fluid osmolarity was measured bilaterally at pre-Sx evaluation and at the 30-days post-Sx visit using the ScoutPro Osmolarity System (Bausch & Lomb, New Jersey). The higher of the two eyes was used for clinical assessment at each time point. A cut-off of ? 315 mOsm/L was selected to define cohorts with visually significant ocular surface disease (OSD) per the American Society of Cataract and Refractive Surgery algorithm for preoperative diagnosis and treatment of ocular surface disease.
Results
71 subjects were tested (mean age 63.1�14.8; 45 Females, 26 Males), of which 31 subjects (44%) exhibited elevated osmolarity ? 315 mOsm/L. At the 30-day post-surgical visit, 59 of the original 71 subjects followed up. 31% of the pre-Sx normal subjects became hyperosmolar post-surgery. Only 50% of the pre-Sx hyperosmolar patients normalized despite topical corticosteroid, NSAID, anti-bacterial and artificial tear treatment during the post operative period.
Conclusion
Hyperosmolarity is common 30 days following cataract surgery suggesting an impact on the ocular surface unresolved by standard therapeutic routine. Risk of elevated light-scatter and visually significant sequelae from a hyperosmolar tear film may lead to poor patient satisfaction and visual quality requiring additional targeted therapy.
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