interface; 0.1% (1/844) had foreign body sensation; 0.2% (2/844) had pain; and 0.7% (6/844) had ghosting or double images in the operative eye. The following complications did NOT occur 3 months following LASIK in this clinical trial: corneal edema and need for lifting and/or reseating the flap/ cap. Adverse Events and Complications for Hyperopia: Certain adverse events and complications occurred after the LASIK surgery. Only one adverse event occurred during the clinical study: one eye (0.4%) had a retinal detachment or retinal vascular accident reported at the 3 month examination. The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; epithelium of > 1 mm2 in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction. The following complications occurred 6 months after LASIK during this clinical trial: 0.8% (2/262) of eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface. The following complications did NOT occur 6 months following LASIK in this clinical trial: corneal edema; foreign body sensation; pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap. Adverse Events and Complications for Mixed Astigmatism: Certain adverse events and complications occurred after the LASIK surgery. No protocol defined adverse events occurred during the clinical study. However, two events occurred which were reported to the FDA as Adverse Events. The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. The second event involved the treatment of an incorrect axis of astigmatism which required retreatment. The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; corneal epithelial defect involving the keratectomy at 1 month or later; corneal edema at 1 month or later visible in the slit lamp exam; epithelium of > 1 mm2 in the interface with loss of 2 lines or more of BSCVA; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; uncontrolled IOP rise and retinal detachment or retinal vascular accident. None of the following complications occurred at 3 months after LASIK during this clinical trial: corneal edema; corneal epithelial defect; any epithelium in the interface; foreign body sensation, pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap. Subjects were asked to complete a patient questionnaire preoperatively and at 3-months, 6-months, and 1-year postoperatively. Adverse Events and Complications for Wavefront - guided Myopia: Certain adverse events and complications occurred after the wavefront- guided LASIK surgery. No adverse event occurred during wavefront-guided treatments during this clinical study. The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced or misaligned flap or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg; and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction. The following complications occurred 3 months after wavefront-guided LASIK during this clinical trial: corneal epithelial defect (0.6%); foreign body sensation (0.6%); and pain (0.6%). The following complications did NOT occur 3 months following wavefront- guided LASIK in this clinical trial: corneal edema; any epithelium in the interface; ghosting or double images; and need for lifting and/or reseating of the flap/cap. ATTENTION: The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0 – 6.5 mm and an ablation zone of 9.0 mm. Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.


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US Ophthalmic Review


Call for Submissions US Ophthalmic Review Volume 4 • Issue 2 • Fall 2011


Management of Ocular Inflammation following Routine Cataract Surgery— Topical Corticosteroid (Prednisolone) versus Topical Non-steroidal (Bromfenac)


Keith A Walter, MD, Amy J Estes, MD, Samantha Watson, BS, MS and Mary Ellingboe, MS


Spectral-domain Optical Coherence Tomography Imaging of Age-related Macular Degeneration


Carlos Alexandre de Amorim Garcia Filho, MD, Philip J Rosenfeld, MD, PhD, Zohar Yehoshua, MD, MHA and Giovanni Gregori, PhD


Vitreoretinal Complications of Phacoemulsification


Steve Charles, MD, FACS, FICS


The Role of Ocular Blood Flow in the Pathogenesis of Glaucomatous Damage


Josef Flammer, MD, Katarzyna Konieczka, MD and Andreas J Flammer, MD


www.touchophthalmology.com


European Ophthalmic Review


Volume 6 • Issue 1 • Spring 2012


Triamcinolone Acetonide for the Treatment of Diabetic Macular Oedema


Valentina Sarao, Daniele Veritti and Paolo Lanzetta


Suprachoroidal Drug Delivery – A New Approach for the Treatment of Severe Macular Diseases


Constanze Augustin, Albert Augustin, Manfred Tetz and Stanislao Rizzo


Nutritional Supplements and Age-related Macular Degeneration – Focus on Omega-3 Fatty Acids


Eric Souied


Imaging Modalities for Uveal Melanoma


Kanish Mirchia, Mary E Turell and Arun D Singh


Special Focus —


Age-related Macular Degenaration


www.touchophthalmology.com


Call for submissions US Ophthalmic Review endeavors to support ophthalmologists in their daily practice through peer-reviewed content, including original contributions, commentaries, review articles and case studies. The journal provides comprehensive discussion and analysis of the latest medical advances and therapeutic options available to ophthalmologists to help diagnose, treat and achieve better patient prognoses.


Join the debate With a focus on all aspects of ophthalmology, including practice management and policy, US Ophthalmic Review is always keen to hear from leading authorities wishing to discuss potential submissions and will give due consideration to all manuscripts submitted.


Manuscripts can be submitted to the journal’s Editor, Misty Gilbert. To download the ‘Instructions to Authors’ information, please visit www.touchophthalmology.com


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