Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
Primary Purpose
Cataracts
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational Healon Endocoat
Control Healon EndoCoat
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility Criteria
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
Sites / Locations
- Empire Eye & Laser Center
- Southern California Eye Physicians and Associates
- Scott & Christie and Associates
- Eye Care Specialists
- Berkeley Eye Institute, P.A.
- Focal Point Vision
- Parkhurst NuVision
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational Healon EndoCoat
Control Healon EndoCoat
Arm Description
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Outcomes
Primary Outcome Measures
CUMULATIVE RATE OF INTRAOCULAR PRESSURE (IOP) SPIKES 30 MMHG OR GREATER
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
The percent change in ECC from preoperative to 3 months postoperative will be reported by descriptive statistics by OVD.
Secondary Outcome Measures
Full Information
NCT ID
NCT05575063
First Posted
October 7, 2022
Last Updated
October 9, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05575063
Brief Title
Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
Official Title
Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
Brief Summary
Prospective, multicenter, paired-eye, randomized, subject/evaluator-masked clinical investigation of the experimental EndoCoat OVD versus the control EndoCoat OVD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Healon EndoCoat
Arm Type
Experimental
Arm Description
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Arm Title
Control Healon EndoCoat
Arm Type
Active Comparator
Arm Description
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Intervention Type
Device
Intervention Name(s)
Investigational Healon Endocoat
Intervention Description
Ophthalmic Viscoelastic device
Intervention Type
Device
Intervention Name(s)
Control Healon EndoCoat
Intervention Description
Ophthalmic Viscoelastic device
Primary Outcome Measure Information:
Title
CUMULATIVE RATE OF INTRAOCULAR PRESSURE (IOP) SPIKES 30 MMHG OR GREATER
Description
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".
Time Frame
up to 3-month follow-up
Title
MEAN PERCENT ENDOTHELIAL CELL COUNT (ECC) CHANGE PREOPERATIVELY VS. POSTOPERATIVELY
Description
The percent change in ECC from preoperative to 3 months postoperative will be reported by descriptive statistics by OVD.
Time Frame
up to 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision, Inc. Clinical Trial
Organizational Affiliation
Johnson & Johnson Surgical Vision, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Empire Eye & Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Southern California Eye Physicians and Associates
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Scott & Christie and Associates
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Berkeley Eye Institute, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Focal Point Vision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Parkhurst NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
IPD Sharing URL
http://yoda.yale.edu
Learn more about this trial
Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
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