Safety and Efficacy of HydroLenz for Vitrectomy-Induced Lens Opacities
NCT ID: NCT05592912
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE1
INTERVENTIONAL
2024-01-01
2025-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery
NCT02093689
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
NCT01230060
A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
NCT00959322
Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.
NCT00804726
Intraindividual Comparison of EMO IOLs
NCT05822089
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low dose HydroLenz treatment
HydroLenz Injection
The HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day
High dose HydroLenz treatment
HydroLenz Injection
The HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day
Control, i.e., no HydroLenz treatment
No HydroLenz Injection
No HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HydroLenz Injection
The HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day
No HydroLenz Injection
No HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 65 years of age or older.
3. Study eye is phakic and scheduled for pars plana vitrectomy (23, 25, or 27 gauge) for epiretinal membrane or vitreomacular traction surgery.
4. Willingness and ability to comply with schedule for follow-up visits.
5. 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
2. History of previous cataract surgery in either eye.
3. Evidence of congenital cataract.
4. Study eye with corneal opacity of one of the following LOCS III grades or condition that would confound the LOCS III grading results:
1. Inability to grade opacities in the study eye with LOCS III at the baseline exam;
2. Inability to dilate pupil to at least 6.0 mm;
3. LOCS III grade ≥ 2 for nuclear opalescence, cortical lens opacities, or posterior subcapsular lens opacities in the study eye at baseline.
5. Diabetic retinopathy or macular edema in the study eye.
6. Retinal vascular disease or retinopathy in the study eye.
7. History of previous intravitreal injections in the study eye.
8. History of previous subconjunctival injections in the study eye.
9. History of previous radiation in the study eye.
10. History of systemic, periocular, inhaled, or chronic topical corticosteroids.
11. Previous laser prophylaxis for retinal tear/hole/lattice degeneration in the study eye.
12. Previous pneumatic retinopexy or retinal detachment repair in the study eye.
13. Previous vitrectomy in the study eye.
14. Previous laser treatment anywhere in the study eye (trabecular meshwork, iris, retina, macula).
15. Use of silicone oil, air or gas tamponade during the vitrectomy in the study eye prior to injection of the HydroLenz.
16. Use of binocular indirect ophthalmoscopy laser during the procedure (endolaser is permitted).
17. History of any previous ocular surgery in the study eye.
18. Any ocular trauma resulting in lens opacity or subluxation of the lens in the study eye.
19. Iatrogenic lens trauma during surgery prior to injection of the HydroLenz.
20. Surgical plan for the vitrectomy includes planned glaucoma filtering or tube-shunt procedure or any procedure affecting the lens.
21. Female patients who are pregnant or lactating or plan to become pregnant during the course of the study.
22. A known sensitivity to study medications for which no alternative medication can be - prescribed.
23. Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the HydroLenz treatment or study participation or may confound the outcome of the study.
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PromiSight, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HL-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.