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Safety and Efficacy of HydroLenz for Vitrectomy-Induced Lens Opacities

NCT05592912 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • Pars Plana Vitrectomy

Interventions

DRUG

HydroLenz Injection

The HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day

OTHER

No HydroLenz Injection

No HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day.

Sponsors & Collaborators

  • PromiSight, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-01-01
Completion
2025-01-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592912 on ClinicalTrials.gov