Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

Completed · Not applicable

Conditions studied: Cataracts

In brief

Prospective, multicenter, paired-eye, randomized, subject/evaluator-masked clinical investigation of the experimental EndoCoat OVD versus the control EndoCoat OVD.

Key facts

Study ID

NCT05575063

Run by

Johnson & Johnson Surgical Vision, Inc.

People needed

165

Starts

2022-11-08

Expected to finish

2023-12-21

Last updated by the study team

2026-06-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Minimum 22 years of age
• Cataracts for which extraction and posterior chamber IOL implantation have been planned in both eyes
• Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better
• Clear intraocular media, other than cataract
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent and HIPAA authorization

You may not qualify if…

• Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study.
• Prior, current, or anticipated use during the course of the 3-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
• Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
• Use of systemic or ocular medications that may affect vision or IOP
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study, or in the opinion of the investigator, may confound the outcome(s) of the study
• Poorly-controlled diabetes
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.).
• Known steroid responder
• Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve
• Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the average of the three cell counts as taken by the Konan Specular Microscope)
• Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
• Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial

Where it is running

• Empire Eye & Laser Center — Bakersfield, California, United States
• Southern California Eye Physicians and Associates — Long Beach, California, United States
• Scott & Christie and Associates — Cranberry Township, Pennsylvania, United States
• Eye Care Specialists — Kingston, Pennsylvania, United States
• Berkeley Eye Institute, P.A. — Houston, Texas, United States
• Focal Point Vision — San Antonio, Texas, United States
• Parkhurst NuVision — San Antonio, Texas, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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