Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

Not Applicable

Completed

Conditions: Cataracts

Interventions: Device: Investigational Healon Endocoat
Device: Control Healon EndoCoat

Registration Number: NCT05575063

Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 165

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Healon EndoCoat	Investigational Healon Endocoat	Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Investigational Healon EndoCoat	Control Healon EndoCoat	Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Investigational Healon EndoCoat	Investigational Healon Endocoat	Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Control Healon EndoCoat	Control Healon EndoCoat	Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.

Primary Outcome Measures

Name	Time	Method
CUMULATIVE RATE OF INTRAOCULAR PRESSURE (IOP) SPIKES 30 MMHG OR GREATER	up to 3-month follow-up	The cumulative count and proportion of eyes with an IOP spike at 3 months will be reported by OVD. Any IOP measurements of 30 mmHg or greater are to be considered a "spike".
MEAN PERCENT ENDOTHELIAL CELL COUNT (ECC) CHANGE PREOPERATIVELY VS. POSTOPERATIVELY	up to 3-month follow-up	The percent change in ECC from preoperative to 3 months postoperative will be reported by descriptive statistics by OVD.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (8): Scott & Christie and Associates
🇺🇸
Cranberry Township, Pennsylvania, United States
Empire Eye & Laser Center
🇺🇸
Bakersfield, California, 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
Southern California Eye Physicians and Associates
🇺🇸
Long Beach, California, United States