Clinical trial NCT05575063: Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
Official title: Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-12
Enrollment: 165
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
2. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject
3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
4. 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.
5. 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)
6. 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
7. Use of systemic or ocular medications that may affect vision or IOP
8. 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
9. Poorly-controlled diabetes
10. 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.).
11. Known steroid responder
12. Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve
13. 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)
14. 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.)
15. 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
16. Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial

Primary outcomes:
measure: CUMULATIVE RATE OF INTRAOCULAR PRESSURE (IOP) SPIKES 30 MMHG OR GREATER
timeFrame: up to 3-month follow-up
measure: MEAN PERCENT ENDOTHELIAL CELL COUNT (ECC) CHANGE PREOPERATIVELY VS. POSTOPERATIVELY
timeFrame: up to 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Long Beach
country: United States
facility: Southern California Eye Physicians and Associates
state: California
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Houston
country: United States
facility: Berkeley Eye Institute, P.A.
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Johnson & Johnson Surgical Vision, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: