The primary objective of this study is to provide safety data for two different dosages of HydroLenz. Secondary objectives are to provide preliminary data to determine whether HydroLenz has the same effect in humans as it does in the porcine model; to confirm the reliability of methods for evaluating lens opacity; and, to acquire information that can be used to design the pivotal study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
The HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day
No HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day.
Evaluation of Changes in Lens Opacities
The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.
Time frame: Baseline and 6 Months
Evaluation of Changes in Lens Opacities
The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.
Time frame: Baseline and 12 Months
Changes in BSCVA
Number of eyes losing more than 2 lines of BSCVA
Time frame: Baseline and 6 Months
Changes in BSCVA
Number of eyes losing more than 2 lines of BSCVA
Time frame: Baseline and 12 Months
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