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 range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.