A Controlled Study Of The Use Of BiOptic Telescopes By Patients With Macular Degeneration For Driving - With Follow-Up Janet Szlyk, PhD VA Chicago Health Care System/ University of Illinois at Chicago

Colleagues  William Seiple, PhD  Denice Laderman, MS  Roger Kelsch, RKT  Joan Stelmack, OD  Timothy McMahon, OD  Kenneth Alexander, PhD  Gerald Fishman, MD

Visual Criteria for Driving in Most US States Visual acuity of 20/40 or better Worse than 20/40 to 20/70 Daytime only Binocular visual field of 140 degrees Monocular visual field of 105 degrees

Research Focus: Disease-based performance profiles Central Vision Loss - Age-Related Macular Degeneration - Juvenile-Onset Macular Dystrophies Peripheral Vision Loss - Retinitis Pigmentosa - Hemianopsia due to Stroke Both Central & Peripheral - Glaucoma - Diabetic Retinopathy

Measurement of Driving Performance Simulator Methods

Comparison to Norms

Road Course Performance Recognition – Speed, Following Distance Mobility – Pulling-Out Behavior, Navigating Complex Environments Peripheral Detection – Lane Position, Locating Signs/Landmarks Scanning – Spotting through Lenses

Disease-Based Risk Profiles: Central Vision Loss Age-Related Macular Degeneration

Visual Acuity Limitations 20/30 to 20/100 Significantly more control subjects than patients were involved in accidents The AMD group had poorer performance on the driving simulator and the road course Evidence of compensation in 4 areas

Compensation Not driving in unfamiliar areas Traveling at slow speeds Self-restricting their nighttime driving Taking fewer risks while driving

Juvenile Macular Dystrophies Central visual field scotomas Reduced visual acuity Color vision abnormalities

Visual Fields - JMD

Visual Acuity Limitations 20/40 to 20/70 The proportion of individuals involved in accidents in the central vision group was comparable to that of the control group Those who drove at night had a higher likelihood of accident involvement

Retinitis Pigmentosa Group of inherited retinal degenerations Progressive loss of visual field Poor vision in dim light Central vision may remain intact until later stages of the disease

Visual Fields - RP

Visual Field Limitations 20/40 or better visual acuity 88% of patients with constricted visual fields less than or equal to 100° diameter had one or more accidents in the prior five years; whereas, only 25% of the patients with greater than 100° diameter had one or more accidents in this time period.

Model for Accident Risk in RP Visual field extent + Braking pressure + Braking response time to a stop sign = Real- world accidents Binocular visual field area + Lane position + Speed = Real-world accidents

Proposed Model for Accident Risk Simulator variables (Abruptness of braking, Speed, Response time, Lane boundary crossings, Brake pressure, Simulator accidents) On-road variables (Stop sign responses, lane observance, overall score) Risk-taking Binocular visual acuity Visual field extent

Summary of Disease-Based Research: 20/40 -20/70 Daylight Restriction – JMD Monocular visual field of 105 degrees – RP and Glaucoma Bioptic Telescope with 20/100 vision – AMD; JMD

Goals To Develop a Rehabilitation and Training Program for Use with Optical Enhancement Devices To Develop and Validate an Assessment Battery That Will Allow Objective Evaluation of the Training Program

Three phases of our research: Phase 1- Bilateral Peripheral Visual Field Loss Using Amorphic Lenses Phase 2 - Central Vision Loss Using Bioptic Telescopes Phase 3 - Hemifield Loss Using Prism Lenses and Gottlieb Visual Field Awareness Systems

Central Visual LossWith Bioptic Telescope

BiOptic Study Inclusion Criteria Central Vision Loss Due to Macular Degeneration (N=7), Stargardt disease (7), Cone-Rod Dystrophy (3), Retinopathy of Prematurity (2), Albinism (1), Best’s disease (1), Cone-Dystrophy (1), Diabetic (1), Macular Hole (1), Pattern Dystrophy (1) Bioptic Telescopic Lens Prescription: 3X or 4X power

Patient Profiles

Study Design Patients Divided into 3 Experimental Groups Matched on Age, Gender, and Clinical Variables Day 1 Day 2 Day 3 Group A W/O lenses Training W/ lenses No training W/ lenses Group B W/O lenses No training W/O lenses Training W/ lenses No lenses Group C W/O lenses No Training W/ lenses lenses

Data Analysis Test-Retest Reliability (Group B (Delayed): Day 1 to Day 2) Training Effects (Group A (Immediate): Day 1 to Day 2) (Group B: Day 2 to Day 3) (Group C: Day 1 to Day 2/No Training) Sustained Effects of Training (Group A: Day 1 to Day 3)

Laboratory and Real-World Training 5 sessions Locating Objects with The Lenses Tracking Stimuli and Visual Memory Skills Using Scanning Skills to Gather Visual Information Navigating Complex Environments

On-Road Training 8 Sessions Vehicle Instrument Orientation and Spotting Techniques Pulling-Out Techniques, Proper Following Distance, Maintaining Proper Lane Position Locating Building Numbers, and Landmarks Awareness of Critical Peripheral Information

On-Road Training (continued) Visual Memory Skills Utilizing Side and Rear-View Mirrors Navigating Complex Environments as a Passenger

Indoor Functional Assessment 39 Items Recognition, Mobility, Peripheral Detection, Scanning, Tracking, and Visual Memory Tasks

Outdoor Functional Assessment 53 Items Recognition, Mobility, Peripheral Detection, Scanning, Tracking, and Visual Memory Tasks

Driving Simulator Assessment Recognition - Speed Mobility - Accidents, Braking Response Times to Traffic Lights and Stop Signs, Braking Pressure, Deceleration Ratio Peripheral Detection - Lane Boundary Crossings Scanning - Horizontal and Vertical Eye Movements

On-Road Driving Assessment Recognition - Speed, Following Distance Mobility - Pulling-Out Behavior, Navigating Complex Traffic Environments Peripheral Detection - Lane Position, Locating Signs/Landmarks, Side Mirror Use, Noticing Critical Peripheral Information Scanning - Spotting Through Lenses, Visual Memory, Remembering Critical Information in Traffic

Psychophysical Tests Attentional Visual Acuity - Letter Optotype Sizes Ranging from 20/50 to 20/700 Tested at 7°, 14°, 23° eccentricity Attentional Motion Sensitivity - Drift Rates of Sinusoidal Grating from 0.6 to 30 Cycles/Second Peripheral Detection - Detect and Identify Targets Presented Randomly at 4 Peripheral Locations

Visual Skills Categories The Individual Tasks within The Assessment Battery Were Coded Independently by Three Investigators According to The Primary Visual Skill Involved in Each Task: Recognition, Mobility, Peripheral Detection, Scanning, Tracking, and Visual Memory

Visual Skills Categories Recognition - Tasks Requiring Central Vision Mobility - General Orientation and Navigation Peripheral Detection - Tasks Requiring Peripheral Vision Scanning - Locating Objects Tracking - Visual Following Visual Memory - Recalling Objects

Data Analysis Calculated the Change for each Patient for each Task for Group B (Day 2 - Day 1) Averaged Change for each Task across Patients Effects of Training - Individual Patient’s Scores Coded As Improvement If They Exceeded The Average For The Control Condition For That Task We Calculated The Percentage Of Tasks Showing Improvement Within Each Visual Skills Category

Results Bioptic – Group A (Immediate)

Results Bioptic – Group B (Delayed)

Results Sustained Effect (6 mo.)/Group A

Trained vs. Untrained Groups  Greater Improvement in: Recognition (p < 0.05); Peripheral Identification (0.02); Scanning (0.03)  Not Statistically Different in: Mobility (0.06), Tracking (1.5), Visual Memory (0.07)

Analyzing Driving-Related Skills  Percentage of DR Skills showing improvement for each group  Group A (Immediate Training) – 62%  Group B (Delayed Training) – 66%  Group C (No Training) – 55%

How Do You Like The Bioptic Telescopic Lenses? Extremely Satisfied - 82% Very Satisfied - 0% Satisfied - 18% Somewhat Satisfied - 0% Unsatisfied - 0%

How Will You Use The Bioptic Telescopic Lenses? Grocery Shopping Viewing Movies at the Theater Reading Signs Recognizing Faces

Results Across Systems

Two-Year Follow-Up Able to contact 23 out of the 25 patients

Two-Year Follow-Up 11 (47.8%) of the patients reported that their vision had changed in the 2 years since the study

Two-Year Follow-Up 10 patients were driving 4 used the BiOptics

Two-Year Follow-Up Reported Frequency of Use 4 (17.4%)Use Frequently 12 (52.2%)Occasionally 7 (30.4%)Never

Two-Year Follow-Up Stated BiOptic Uses Reading chalkboard Shopping Seeing things as car passenger TV or movie viewing Address locating Sporting events Bird watching

Conclusions Optical enhancement devices are useful to patients with compromised vision when combined with O&M and driving training Improve Quality of Life for persons with reduced central vision

Conclusions Training with BiOptics Improves Performance on Visual Skills Tasks Research on the effectiveness of individual training techniques and the time course of skill acquisition could lead to a standardization of BiOptic Training Methods

Acknowledgements U.S. Department of Veterans Affairs Rehabilitation Research & Development Service; AAA Foundation for Traffic Safety; Illinois Eye Fund; Foundation Fighting Blindness; Research to Prevent Blindness, Inc., NEI Core Grant EY01792