Patient-Reported Outcomes with LASIK (PROWL-1) Results

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1 Patient-Reported Outcomes with LASIK (PROWL-1) Results Elizabeth M. Hofmeister, MD CAPT, MC, USN Naval Medical Center San Diego Refractive Surgery Advisor for Navy Ophthalmology Assistant Professor of Surgery, Uniformed Services University

2 Disclosures The views expressed in this study are the author s and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the U.S. Government. I have no financial disclosures. My spouse has no financial disclosures.

3 PROWL-1 Study Objectives Evaluate the validity of a computer-based questionnaire assessing patient reported outcomes which is administered prior to and following LASIK surgery Evaluate the ease of survey administration as well as pilot the instrument prior to using it in the general population Explore the prevalence of any functional limitations and their associated factors at one, three, and six months after LASIK surgery Explore the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, and six months following LASIK surgery

4 Navy Warfighter Refractive Surgery Program Goal: to improve the safety and operational readiness of active duty service members Over 150,000 procedures performed in the Navy since the year 2000

5 PROWL 1 Methods: Surgical Technique Four surgeons, highly standardized techniques Femtosecond LASIK flaps Two excimer platforms in use at Navy Refractive Surgery Center San Diego Wavefront-guided platform Wavefront-optimized platform

6 Data Collection*: Clinic Visits and Questionnaires Subjects enrolled 262 Subjects who underwent surgery 242 Post-op clinic visit completion rates 1- month 3- months 6- months Questionnaire completion rates 1- month 3- months 6- months Number (%) 234 (97%) 225 (93%) 217 (90%) 242 (100%) 233 (96%) 224 (93%) 217 (90%) *Study enrollment and follow-up were impacted by ongoing military deployments

7 PROWL-1 Study Population Gender Men Women Subjects Who Underwent Surgery 192 (79%) 50 (21%) Age, years: mean (range) 29.1 (21-52) Refractive Correction Ethnicity Race Glasses Contact lenses None/Not listed Not Hispanic or Latino Hispanic or Latino Unknown White Black or African American Asian Native American Pacific Islander Unable to Specify Other 46% 50% 4% 79% 20% 1% 55% 10% 9% 2% 2% 1% 21%

8 Study Population: Refractive Error Category Preoperative Refractive Error Myopia n = 446 eyes Mean sphere: -2.5 D (range 0 to -7.8 D, SD 1.71) Mean cylinder: 0.8 D (range 0 to 3.3 D, SD 0.59) Mean spherical equivalent: -2.9 D (range -0.6 to -8.0 D, SD 1.67) Hyperopia n = 10 eyes Mean sphere: +3.1 D (range +2.3 to +4.0 D, SD 0.64) Mean cylinder: 1.1 D (range 0.3 to 3.0 D, SD 0.89) Mean spherical equivalent: +2.5 D (range +1.5 to +3.6 D, SD 0.81) Mixed Astigmatism n = 28 Mean sphere: +0.6 D (range +0.3 to +1.8 D, SD 0.43) Mean cylinder: 2.1 D (range 0.8 to 6.0 D, SD 1.07) Mean spherical equivalent: -0.5 D (range -2.4 to +0.3D, SD 0.62)

9 PROWL-1 Adverse Events Adverse Events 6 Flap miscreation, no LASIK performed* Flap dislocation post op day #1 Loss of 2 lines BCVA (20/16 pre-op, 20/25 at 3 months) Recurrent corneal erosions Central serous chorioretinopathy *Subjects with flap miscreation had PRK at a later date. Both had 20/16 or better uncorrected visual acuity at 6 months post op.

10 Lines Gained/Lost at 3 and 6 Months: BCVA compared to postop BCVA Number of eyes months 6 months 50 1 eye at 3 months, BCVA = 20/ lines -1 line 0 lines +1 line +2 lines

11 Best Corrected Visual Acuity vs. Post-op Binocular Uncorrected Visual Acuity Efficacy of All Treatments 120% 100% 96% 100% 100% 100% 100% 99% 100% 99.5% 100% 99% 98% 99% 80% 70% 69% 76% 20/10 60% 20/ /16 40% 34% 20/20 20/25 20% 8% 12% 13% 0% 1% 1 month 3 months 6 months Best corrected Uncorrected

12 PROWL-1 Visual Symptoms

13 Prevalence of any Visual Symptoms: Baseline vs. 1, 3, and 6 months 60% 50% 53% Increased at 1 month 49% 47% 40% 30% 20% 29% 41% 41% 36% 23% 17% 37% 28% 34% 32% 1 month 3 months 6 months 10% 8% 7% 6% 0% Ghost Images Glare Halos Starbursts

14 Prevalence of Preoperative Visual Symptoms % Number of patients % 59% 41% 59% 41% 51% 49% No Yes 20 0 Double Ghost Images Glare Halos Starbursts Glare Halos Starbursts

15 Prevalence of New Visual Symptoms at 6-months % New visual symptoms at 6 months 8 Subjects 16 Subjects 33 Subjects Number of patients % 26% 34 Subjects 30% No Yes 20 0 n = 154 n = 62 n = 131 n = 84 n = 127 n = 89 n = 110 n = 104 Double Images Glare Halos Starbursts Ghost Images Glare Halos Starbursts

16 Resolution of Visual Symptoms at 6 months Resolved visual symptoms at 6 months Subjects Number of patients Subjects 91% 63 Subjects 75% 62 Subjects 70% 66% No Yes 0 n = 154 n = 62 n = 131 n = 84 n = 127 n = 89 n = 110 n = 104 Double Images Glare Halos Starbursts Ghost Images Glare Halos Starbursts

17 Difficulty with Usual Activities due to Visual Symptoms (With and Without Best Vision Correction) Ghost Images A lot of difficulty 1 Month 3 Months 6 Months Unable to do some activities A lot of difficulty Unable to do some activities A lot of difficulty Unable to do some activities Number of subjects Number of subjects Number of subjects Number of subjects Number of subjects Number of subjects With best vision correction Without best vision correction Glare With best vision correction Without best vision correction Halos Starbursts With best vision correction Without best vision correction With best vision correction Without best vision correction

18 Difficulty with Usual Activities due to Visual Symptoms (With and Without Best Vision Correction) Ghost Images A lot of difficulty 1 Month 3 Months 6 Months Unable to do some activities A lot of difficulty Unable to do some activities A lot of difficulty Unable to do some activities Number of subjects Number of subjects Number of subjects With best vision correction Without best vision correction Glare With best vision correction Without best vision correction Halos With best vision correction Starbursts Without best vision correction With best vision correction Without best vision correction Less than 1% of subjects experienced significant or debilitating difficulties doing usual activities due to visual symptoms, irrespective of correction.

19 Summary of Visual Symptoms Findings For the cohort, the prevalence of visual symptoms decreased from pre-op as compared to 6 months For each symptom index, up to 30% of patients reported new symptoms Up to 91 % of patients with pre-op symptoms reported resolution of those symptoms post op Very few patients noted that visual symptoms negatively impacted their daily activities.

20 PROWL-1 Dry Eye Signs and Symptoms U.S. Navy Photo Arch Ophthalmol. 2000; 118:

21 Oxford Scores: Lissamine Green Slit Lamp Exam 100% 90% Lower score = less ocular surface staining 80% 70% 60% 50% 40% 30% 20% Increase in staining at 1 month post op Score = 0 (Absent) Score = 1 (Minimal) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Marked) Score = 5 (Severe) 10% 0% Baseline 1-month 3-months 6-months

22 Ocular Surface Disease Index (OSDI) 80% 70% 60% 50% Lower score = less dry eye symptoms Normal % 30% 20% 10% 19% 10% Mild > 12-22) Moderate (>22-32) Severe (>32-100) 0% 1 month 3 months 6 months n=240 n=232 n=222 n=215

23 Preoperative Ocular Surface Disease Index (OSDI) Scores % Normal Mild Moderate Severe Number of Patients How many of the patients with normal baseline symptoms worsened after surgery? 25.4% 13.3% % 0 Normal Mild Moderate Severe

24 Prevalence of Subjects with Normal OSDI Scores Who Had Worsening OSDI Scores at 6 Months Number of Patients % 80.5% 0.8% severe 5% moderate Normal Mild Moderate Severe 21% (23 subjects) with a normal pre-op OSDI noted mild, moderate, or severe dry eye at 6 months (n =16 mild, n = 6 moderate, n = 1 severe ) Normal n= 118 Mild n= 54 Moderate n= 29 Severe n= 14

25 Prevalence of Subjects with Mild/Moderate/Severe OSDI Scores Who Had Normal OSDI Scores at 6 Months Normal Mild Moderate Severe Number of Patients Normal n= % 69% Mild n= 54 1% severe 6% moderate 65% of patients with pre-op mild, moderate, or severe dry eye symptoms had normal OSDI scores at 6 months (63 subjects) 31% 59% Moderate n= 29 2% severe 1% moderate 64% Severe n= 14 1% severe 29% moderate

26 Summary of Dry Signs and Symptoms For the cohort, Oxford scores worsened at one month, and then returned to preoperative scores For the cohort, OSDI scores improved from pre-op as compared to 6 months Up to 21% of patients with normal pre-op OSDI scores had mild/moderate/severe OSDI scores at 6 months 65% of patients with mild/moderate/severe OSDI scores preop had normal scores at 6 months

27 How satisfied are you with the result of your LASIK surgery? % satisfied at 6 months 140 Number of Patients Completely satisfied Very satisfied Somewhat satisfied Somewhat dissatisfied Very dissatisfied Completely dissatisfied dissatisfied patients (2%) 0 1 month 3 months 6 months

28 How satisfied are you with your present vision? 160 Number of Patients % Satisfied pre-op 97% satisfied at 6 months Completely satisfied Very satisfied Somewhat satisfied Somewhat dissatisfied Very dissatisfied Completely dissatisfied 20 6 dissatisfied patients (3%) 0 Baseline 1 month 3 months 6 months

29 Satisfaction Based on Clinical Outcomes: 6-month Data Satisfied n = 197 Dissatisfied n = 6 Mean (Stand. Dev.) Range Mean (Stand. Dev.) Range Spherical equivalent, diopters Residual cylinder, diopters Spherical aberration Trefoil Coma Higher order aberration root mean squared, microns Higher order aberration, % of overall aberration OD -0.1 D (0.20 D) -1.1 D to +0.4 D -0.1 D (0.29 D) -0.1 to -0.5 D OS 0.0 D (0.23 D) -0.9 D to +1.0 D -0.1 D (0.49 D) -1.0 to +0.5 D OD 0.2 D (0.26D) 0.0 D to 1.5 D 0.3 D (0.22 D) 0.0 to 0.5 D OS 0.2 D (0.23 D) 0.0 D to 1.0 D 0.3 (0.40 D) 0.0 to 1.0 D OD 0.1 (0.18) -0.3 to (0.12) 0.0 to +0.3 OS 0.2 (0.17) -0.3 to (0.09) 0.0 to +0.2 OD 0.1 (0.09) 0.0 to (0.06) 0.0 to 0.2 OS 0.1 (0.09) 0.0 to (0.06) 0.0 to 0.2 OD 0.2 (0.14) 0.0 to (0.09) 0.1 to 0.3 OS 0.2 (0.13) 0.0 to (0.05) 0.0 to 0.2 OD 0.4 (0.17) 0.1 to (0.14) 0.2 to 0.5 OS 0.4 (0.16) 0.1 to (0.17) 0.2 to 0.3 OD 47.6% (19.89) 8.0 to % (20.49) 7.8 to 59.9 OS 47.8% (20.89) 10.9 to % (19.30) 17.4 to 68.0

30 Satisfaction Based on Clinical Outcomes: 6-month Data Satisfied n = 197 Dissatisfied n = 6 Mean (Stand. Dev.) Range Mean (Stand. Dev.) Range Spherical equivalent, diopters Residual cylinder, diopters Spherical aberration Trefoil Coma Higher order aberration root mean squared, microns Higher order aberration, % of overall aberration OD -0.1 D (0.20 D) -1.1 D to +0.4 D -0.1 D (0.29 D) -0.1 to -0.5 D OS 0.0 D (0.23 D) -0.9 D to +1.0 D -0.1 D (0.49 D) -1.0 to +0.5 D OD 0.2 D (0.26D) 0.0 D to 1.5 D 0.3 D (0.22 D) 0.0 to 0.5 D OS 0.2 D (0.23 D) 0.0 D to 1.0 D 0.3 (0.40 D) 0.0 to 1.0 D OD 0.1 (0.18) -0.3 to (0.12) 0.0 to +0.3 OS 0.2 (0.17) -0.3 to (0.09) 0.0 to +0.2 OD 0.1 (0.09) 0.0 to (0.06) 0.0 to 0.2 OS 0.1 (0.09) 0.0 to (0.06) 0.0 to 0.2 OD 0.2 (0.14) 0.0 to (0.09) 0.1 to 0.3 OS 0.2 (0.13) 0.0 to (0.05) 0.0 to 0.2 OD 0.4 (0.17) 0.1 to (0.14) 0.2 to 0.5 OS 0.4 (0.16) 0.1 to (0.17) 0.2 to 0.3 OD 47.6% (19.89) 8.0 to % (20.49) 7.8 to 59.9 OS 47.8% (20.89) 10.9 to % (19.30) 17.4 to 68.0

31 Satisfaction Based on Clinical Outcomes: 6-month Data Satisfied n = 197 Dissatisfied n = 6 Mean (Stand. Dev.) Range Mean (Stand. Dev.) Range Spherical equivalent, diopters Residual cylinder, diopters Spherical aberration Trefoil Coma Higher order aberration root mean squared, microns Higher order aberration, % of overall aberration OD -0.1 D (0.20 D) -1.1 D to +0.4 D -0.1 D (0.29 D) -0.1 to -0.5 D OS 0.0 D (0.23 D) -0.9 D to +1.0 D -0.1 D (0.49 D) -1.0 to +0.5 D OD 0.2 D (0.26D) 0.0 D to 1.5 D 0.3 D (0.22 D) 0.0 to 0.5 D OS 0.2 D (0.23 D) 0.0 D to 1.0 D 0.3 (0.40 D) 0.0 to 1.0 D OD 0.1 (0.18) -0.3 to (0.12) 0.0 to +0.3 OS 0.2 (0.17) -0.3 to (0.09) 0.0 to +0.2 OD 0.1 (0.09) 0.0 to (0.06) 0.0 to 0.2 OS 0.1 (0.09) 0.0 to (0.06) 0.0 to 0.2 OD 0.2 (0.14) 0.0 to (0.09) 0.1 to 0.3 OS 0.2 (0.13) 0.0 to (0.05) 0.0 to 0.2 OD 0.4 (0.17) 0.1 to (0.14) 0.2 to 0.5 OS 0.4 (0.16) 0.1 to (0.17) 0.2 to 0.3 OD 47.6% (19.89) 8.0 to % (20.49) 7.8 to 59.9 OS 47.8% (20.89) 10.9 to % (19.30) 17.4 to 68.0

32 Satisfaction Based on 6-Month Visual Symptoms Complaint of mild, moderate or severe 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2 of 6 4 of 6 3 of 6 Satisfied, n = 195 Dissatisfied, n= 6 2 of 6 Glare Halos Starbursts Double Images Visual Symptoms at 6 months

33 Satisfaction Based on 6-Month Ocular Surface Disease Index (OSDI) Scores 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2 of 6 1 of 6 1 of 6 Satisfied, n = 210 Dissatisfied, n= 6 Normal Mild Moderate Severe OSDI Scores 6 months 2 of 6

34 PROWL-1 Conclusions PROWL-1 is the first prospective study to evaluate multiple aspects of the patient's experience with LASIK including expectations, satisfaction, visual symptoms and their impact on functioning PROWL-1 showed excellent objective clinical results 99.5% achieved uncorrected binocular vision of 20/20 or better No subject lost more than 2 lines of BCVA

35 PROWL-1 Conclusions (continued) Visual Symptoms Preoperative visual symptoms were prevalent in military patients The prevalence of visual symptoms decreased over time in all categories after one month While some patients reported new visual symptoms, more patients reported resolution of their pre-op visual symptoms

36 PROWL-1 Conclusions (continued) Dry Eye Signs & Symptoms For the cohort, Oxford Scores worsened at 1-month post op, then improved Preoperative dry eye symptoms were prevalent in military patients The prevalence of patients with normal OSDI scores increased over time for the cohort While some patients developed worsening dry eye symptoms, more patients dry eye symptoms improved

37 PROWL-1 Conclusions (continued) Satisfaction Predictors Very few patients were dissatisfied with their LASIK surgery at 6 months: 4 subjects out of 215 (2%) Very few patients were dissatisfied with their vision at 6 months: 6 subjects out of 216 (3%) Too few dissatisfied subjects for statistical conclusions More likely to have visual symptoms

38 PROWL-1 Conclusions (continued) LASIK is an elective surgical procedure, and no surgical procedure is without risk PROWL-1 gives us important data to further enhance our discussions with patients about risks and benefits of surgery

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