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Study Design:•Open-label•multi-center (x4) study•12 weeks treatment
Subjects: 24 children (10.8 ± 3.9 years; range 5 to 17); anisometropic amblyopia; unsuccessfully treated in the past
Inclusion criteria:1.Mild/moderate anisometropic amblyopia:
• BCVA 0.2 logMAR or better in non-amblyopic eye• Amblyopic eye BCVA +0.2/+0.7 logMAR• Anisometropia >1.00DS or >1.50DC
2.Full-time best-correction >8 weeks prior to EFG1.No amblyopia treatment 1 month prior
• spectacle frame with LCD lenses• electronic shutter • accurate/rapid alternating occlusion rate
EFG pre-programmed (for this study): • 7Hz (refs)• 50% cycle
EFG regime:• daily (6-7 days/week)• 1-2 hours/day• near vision tasks (open): o readingo homeworko computero video games
Outcome measures: 1. logMAR VA (ETDRS procedure)2. stereopsis (Random Dot 2)3. fusion (Worth-4 dot with Bangerter filters)
Amblyopia is a neurological development disorder that presents with de7icits in spatiotemporal vision processing resulting from an active suppression process. The current standard of care for amblyopia involves visual penalization (using patching, often for several hours a day, or atropine) of the “good”, non-‐amblyopic, eye. We propose and evaluate an alternative treatment method that does not penalize the patient’s ability to see while being treated and promotes normal binocular vision: the Eyetronix Flicker Glasses (EFG). The objective of this study is to evaluate the feasibility and ef7icacy of the novel EFG Therapy for amblyopia.PLEASE NOTE: Data from this study will be presented as “Improved Compliance with a Novel EFG Therapy for the Treatment of Amblyopia ” Poster board Number: 802 -‐ D0045
! Hypotheses
Conclusions
! Methods cont’d ResultsPurpose
Moore, Bruce1; Vera-Diaz, Fuensanta1, Srinivasan, Gayathri1, Johnson, Catherine1, Hussey, Eric2, Spivey, David3, Tattersall, Paulette1, Gleason, William4.
1New England College of Optometry, Boston, MA 2Private practice, Spokane, WA 3Private practice, Ft. Worth, TX 4Foresight Regulatory Strategies, Inc, Wilmington, MA
Relationship(s); EyeTronix, Inc. Code F (Financial Support)•Bruce Moore •Fuensanta Vera-Diaz•Gayathri Srinivasan•Catherine Johnson•Paulette TattersallRelationship(s); EyeTronix, Inc. Code C (Consultant)•Eric Hussey•David Spivey•William J. GleasonContact: Dr. Fuensanta Vera-Diaz [email protected] Dr. Bruce Moore [email protected]
! Methods
Eyetronix Flicker Glass (EFGs)
Results cont’d
Ini<al Evalua<on of the Eyetronix Flicker Glass A Novel Amblyopia Therapy
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• Promising benefit of EFG Therapy as a treatment for amblyopia in (older) children
• Results comparable to previous studies using patching or atropine
• Improvement stereopsis/daily activities suggest EFG Therapy promotes binocular vision
Improvement amblyopic eye [-0.12 ± 0.11 logMAR] >> non-amblyopic eye
[-0.01 ± 0.08] (p=0.002)
25% improved 2 lines or more
1. PEDIG. Arch Ophthalmol. 2005. 2. Schor et al, JOPO, 1976. 3. de Belsunce et al, IOVS, 1991. 4. Hussey, JOVD, 1995.
5. Hussey JBO1999; JBO 2007. 6. Miller et al, JOVD, 2000. 7. Spierer et al, IOVS 2010.8. PEDIG, Ophthalmology, 2008
! References
Affecting Suppression? How do we measure?Changing Masking at the Cortex (Schor)?Affecting Motion Detection at LGN (Hussey)?
Affecting Masking AND Motion Detection (Hussey unpubl)?
Improvement in VA Independant of Age Older Teenagers also improved
22 (/24) subjects improved either global or local stereopsis
NO Adverse Events
Anecdotal Reports of Real-World changes in Daily Tasks and Depth
#105: “I can now bounce the ball on the end of the hockey stick ! and I couldn’t before.”#305:”My son’s ping-pong game has significantly improved!”#311: separate case study - 5 y.o. monocular aphake improving in ! acuity and stereopsis, as well as change in real-world depth ! perception reported by mom
Wednesday, May 7, 2014