Safety and Efficacy of HydroLenz for Vitrectomy-Induced Lens Opacities (NCT05592912) | Clinical Trial Compass
WithdrawnPhase 1
Safety and Efficacy of HydroLenz for Vitrectomy-Induced Lens Opacities
Stopped: Funding Limitations
0Started 2024-01-01
Plain-language summary
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.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Male or female of any race.
✓. 65 years of age or older.
✓. Study eye is phakic and scheduled for pars plana vitrectomy (23, 25, or 27 gauge) for epiretinal membrane or vitreomacular traction surgery.
✓. Willingness and ability to comply with schedule for follow-up visits.
✓. Subject understands the study requirements and the treatment procedures and provides signed, written informed consent obtained in accordance with the institutional review board (or ethics committee) requirements for this first-in-man early feasibility study.
Exclusion criteria
✕. Aphakic or pseudophakic lens status in either or both eyes.
✕. History of previous cataract surgery in either eye.
✕. Evidence of congenital cataract.
✕. Study eye with corneal opacity of one of the following LOCS III grades or condition that would confound the LOCS III grading results:
✕. Inability to grade opacities in the study eye with LOCS III at the baseline exam;
✕. Inability to dilate pupil to at least 6.0 mm;
✕. LOCS III grade ≥ 2 for nuclear opalescence, cortical lens opacities, or posterior subcapsular lens opacities in the study eye at baseline.