Tear Osmolarity in Refractive Surgery: Its Impact on Clinical Outcomes

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1 Tear Osmolarity in Refractive Surgery: Its Impact on Clinical Outcomes Hawaiian Eye 2013 Marguerite McDonald, MD, FACS Clinical Professor of Ophthalmology NYU Langone Medical Center New York, New York Adjunct Clinical Professor of Ophthalmology Tulane University Health Sciences Center New Orleans, Louisiana Ophthalmic Consultants of Long Island Lynbrook, New York

2 Financial Disclosures AMO-Abbott, Alcon, Allergan, B&L, FOCUS Labs, OCuSOFT, OCULUS, TearLab, TearScience, NexisVision, ORCA

3 What s at Stake in Not Accurately Diagnosing and Treating Dry Eye Pre-existing dry eye is a risk factor for a suboptimal visual outcome, fluctuating vision and reduced contrast sensitivity following LASIK or cataract surgery. Dry eye has a profound negative impact on quality of life. Dry eye tends to be a progressive condition if left untreated.

4 Image Convolution in Post-LASIK Dry Eye Patient Pre- and Post- Punctal Plugs

5 Tear Osmolarity Listed in AAO Preferred Practice Patterns American Academy of Ophthalmology Cornea/External Disease Panel Preferred Practice Pattern (PPP) guidelines

6 LVC and Tear Osmolarity The mean tear osmolarity was significantly increased in LASIK patients 12 months po (P=.009). There was a significant increase in LASIK & LASEK pts with a TOT > 308 mosm/l at 12 mo, i.e., po LASIK eyes are significantly drier at 1 year. In both groups, there were more eyes > 308 mosm/l at 1 yr. The preop TOT was also significantly and inversely related to the postoperative change in tear osmolarity at 3 months in both groups. At 12 mo, the TOT was significantly and + correlated with the baseline value. This study supports the use of TOT as a screening tool for LVC & suggests that patients' preop TOTs are indicators of their potential postop levels. Dooley I, D Arcy F, M O Keefe. J Cataract Refract Surg 2012; 38:

7 TLC Laser Vision Correction & Tear Osmolarity Study- Eldridge et al Patients with preop hyperosmolarity demonstrated significantly worse UCVA at 3 mo p/o (20/28 vs. 20/19 for normal subjects; p=0.018). All subjects had the same VA up to 1 mo while they were on therapies including corticosteroids and HA-containing tears. Once therapy became uncontrolled, the VA of patients with preop hyperosmolarity regressed significantly. These patients averaged a score of 0.2 out of 4 for ocular surface staining before surgery, making it impossible to distinguish any differences between the two groups with staining.

8 TLC Laser Vision Correction and Tear Osmolarity Study- Eldridge et al Conclusion: stabilizing the tear film prior to LVC can provide significantly better initial surgical outcomes for patients with preop hyperosmolarity. In order to maintain those initial outcomes and thereby reduce the potential need for future enhancement sxs, maintaining Tx for DED patients for an extended period of time following LASIK is necessary.

9 Presurgical Hyperosmolarity Predicts Refractive Outcomes Eric Donnenfeld 1,2 Tina Burr 2 Christopher Freeman 2 Dawn Holsted 2 Christine Kantor 2 Stacy Lerum 2 Don Miller 2 Mark Slosar 2 Joel Sturm 2 Jim Thimons 2 1 Ophthalmic Consultants of Long Island 2 TLC Laser Eye Centers ESCRS 2011 E Donnenfeld

10 Introduction HOAs are decreased and quality of vision correspondingly improves with the use of artificial tears in dry eye disease 1 Preserved tears with sodium hyaluronate have the lowest osmolarity of all tears 2 These tears were shown to improve refractive results following LASIK 3 1. Montés-Mico. JCRS 2007; 2. Benelli, Contact Lens Ant Eye 2010; 3. Donnenfeld. ARVO 2009

11 Osmolarity in Refractive Surgery How tear osmolarity levels relate to visual outcomes following LASIK; & if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively 128 subject (256 eyes) interim 1 month n = 81 normal, n = 47 hyperosmolar Classified as hyperosmolar if the preoperative osm was 308 mosms/l Split into 2 groups: Presurgically treated (n=60) & untreated (n=68) with HA-containing preserved tears LASIK vision correction with the VISX STAR S4 with IR HA-containing preserved tears & surgeon s post-operative protocol Therapy uncontrolled after 1 month ESCRS 2011 E Donnenfeld

12 Preoperative Hyperosmolarity was Predictive of UCVA & BCVA ESCRS 2011 E Donnenfeld

13 Summary: Donnenfeld et al Patients with pre-operative hyperosmolarity ( 308 mosms/l) demonstrated worse UCVA For patients with preoperative osmolarity > 308 mosms/l, it may be important to continue therapy for at least 3 months Surgeons should measure tear osmolarity preoperatively Staining was too insensitive to identify at-risk patients Patients treated pre-operatively with HA-containing preserved tears achieved normal osmolarity faster post-operatively Only tear osmolarity was sensitive enough to track changes over time Changes in staining were significant, but sub-clinical TBUT & symptoms showed no changes after 1 month ESCRS 2011 E Donnenfeld

14 Objective: Dry Eye Study: P.H.A.C.O.: Prospective Health Assessment of Cataract patients Ocular surface To determine the prevalence of dry eye in patients undergoing cat sx Methods: Prospective, multi-center study (9 sites) Mark Packer, MD Damien Goldberg, MD Parag Majmudar, MD Eric Donnenfeld, MD Marguerite McDonald, MD Karl Stonecipher, MD Jon Vukich, MD Chaz Reilly, MD Gregg Berdy, MD Ranjan Malahotra, MD William Trattler, MD 136 patients (272 eyes) scheduled for cataract surgery Avg Age: 70 yrs old (range: 54 to 87) Unrestricted Grant from Allergan William Trattler, MD

15 Summary of PHACO Study (Patients scheduled for Cat Sx): Are Cataract Surgery Patients Symptomatic for Dry Eye? Foreign body sensation complaints: 59%: Never 28%: Some of the time 87% FBS: Half of the time, most or all of the time: only 13% of patients W Trattler et al

16 W Trattler et al Summary of PHACO Study (Patients Scheduled for Cat Sx) Patients are often asymptomatic Dry eye signs are very common in patients scheduled for cataract surgery TBUT: More than 60% with very abnormal TBUT ( 5 seconds) Corneal Staining 50% with Central staining Schirmer s score 21.3% with very low Schirmer s ( 5mm)

17 Why is it Important to Identify and Treat Dry eye & Blepharitis Pre-op? Answer: Because these conditions can impact: LVC WF capture, MR, and laser programming IOL calculations Inaccurate keratometry can lead to wrong IOL power LRIs or Toric IOLs axis and/or magnitude Inaccurate keratometry Inaccurate topography M McDonald

18 Tear Film Reflection Before & After Cyclosporine Before After An optimized tear film improves Ks & IOL calculation as well as improving the wavefront for LASIK custom ablation. E Donnenfeld

19 Preop Evaluation W Trattler pt, 60 year old male: Initial Consultation for Presbyopic IOL

20 Dry Eye Identified: 1 wk after Cyclosporine BID & Topical Steroids W Trattler

21 Phaco & Tear Osmolarity Measured using freezing point depression studies.

22 Sources of Patient Dissatisfaction Following Multifocal IOL Implantation Of 32 multifocal IOL pts (43 eyes), dry eye was identified as cause of blurred VA in 6 (15%) and of photic phenomenon in 1 (6%). Dissatisfaction after M-IOL implantation resolved in 5 eyes (12%) with dry eye tx alone. The use of TOT would be a more sensitive marker in identifying dry eye patients considering M-IOL implantation, allowing preand postop tx. Woodward MA, Randleman JB, Stulting RD. JCRS 35:992-7, 2009.

23 Effect of Topical Cyclosporine in Patients with Multifocal IOLs 28 eyes of 14 M-IOL patients. Two months postop, the CSA group had significantly lower mean UCVA than the ATs group as well as significantly lower mean BCVA & corneal staining scores. TX with CSA 0.05% also improved contrast sensitivity, conjunctival staining, and TBUT. Significantly more pts preferred the eye treated with CSA 0.05% to the eye treated with ATs (57.1% versus 14.3%; P=.007). TOT can be used to identify the dry eye population at risk of postop disatisfaction, who require dry eye tx when implanted with multifocal IOLs. Donnenfeld ED, Solomon R, Roberts CW, et al. J Cataract Refract Surg 36: , 2010

24 In Summary: TOT can assist in identifying pts who need preop & postop tx for dry eye because these conditions can impact: LVC WF capture, MR, & laser programming IOL calculations Inaccurate Ks can lead to wrong IOL power LRIs or Toric IOLs axis and/or magnitude Inaccurate keratometry Inaccurate topography Postop complaints of visual disturbances & poor quality of VA

25 Thank you for your attention!

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