The primary objective of this study is to test the hypothesis that DYME is safe and effective as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining the anterior capsule. Secondary objectives are to compare the safety and effectiveness of DYME to that of a smaller dose of the same API.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Peace Laser Eye Center
Inglewood, California, United States
Center for Excellence in Eye Care
Miami, Florida, United States
Ophthalmology Consultants, Ltd.
Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.
Time frame: During surgery
Uncomplicated discharge
Time frame: Three months post-op
Quality of stain
Time frame: during surgery
Intra-ocular safety of DYME as measured by best corrected visual acuity, corneal endothelial cell count, intraocular pressure, presence/absence of retained dye, duration of surgery, and the absence of dye related adverse events
Time frame: 1-day and 1-week post-op
Intra-ocular safety of DYME as measured by corneal endothelial cell count
Time frame: Three months post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Des Peres, Missouri, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
St. John's Clinic Eye Specialists
Springfield, Missouri, United States
Ballas Surgery Center
St Louis, Missouri, United States
Brar-Parekh Eye Associates
Woodland Park, New Jersey, United States
Island Eye Surgicenter
Carle Place, New York, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
LV Prasad Eye Institute
Hyderabaad, Andhra Pradesh, India
...and 5 more locations