Cataracts
Conditions
Brief summary
Prospective, multicenter, paired-eye, randomized, subject/evaluator-masked clinical investigation of the experimental EndoCoat OVD versus the control EndoCoat OVD.
Interventions
DEVICEInvestigational Healon Endocoat
Ophthalmic Viscoelastic device
DEVICEControl Healon EndoCoat
Ophthalmic Viscoelastic device
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative IOP Spike Rate From Safety Endpoint | 3-month postoperative | The cumulative IOP spike rate is the proportion of eyes that experienced at least one IOP spike within each arm during the 3-month postoperative period. The status of the cumulative IOP spike is either 'Yes, Spike' or 'No, Non-Spike,' and the results of the cumulative IOP spike rate are presented in percentage. For this outcome measure, subjects have been analyzed as per treated received, which gives investigational OVD of 131 participants and 131 eyes treated; and control OVD of 130 participants and 130 eyes treated. |
| ECC Percent Change From Effectiveness Endpoint | 3-month postoperative | The success criterion for the primary effectiveness endpoint was met (modified ITT Population) as the investigational device (HEALON EndoCoat OVD) demonstrated non-inferiority to the control device (HEALON EndoCoat OVD) with respect to the difference in mean ECC percent change. For this outcome measure, subjects have been analyzed as per planned randomization schema, which gives investigational OVD of 130 participants and 130 eyes randomized; and control OVD of 131 participants and 131 eyes randomized. |
Countries
United States
Contacts
STUDY_DIRECTORJohnson & Johnson Surgical Vision, Inc. Clinical Trial
Johnson & Johnson Surgical Vision, Inc.
Participant flow
Recruitment details
A total of 165 subjects were enrolled in the study. Of these, 131 subjects (261 eyes) received the treatment and were included in the analysis.
Pre-assignment details
Participant Flow table and outcome measures arms are divided by 'investigational OVD, one eye treated with investigational HEALON EndoCoat OVD' vs. 'control OVD, one eye treated with control HEALON EndoCoat OVD'.
Participants by arm
| Arm | Count |
|---|---|
| Safety Population Total of 131: 129 contralaterally treated with investigational and control OVDs; 1 bilaterally treated with the investigational OVD; 1 unilaterally treated with the control OVD | 131 |
| Total | 131 |
Baseline characteristics
| Characteristic | Safety Population |
|---|---|
| Age, Customized Age Group 60-69 years old | 58 Participants |
| Age, Customized Age Group <60 years old | 9 Participants |
| Age, Customized Age Group 70-79 years old | 58 Participants |
| Age, Customized Age Group >=80 years old | 6 Participants |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Race Asian | 5 Participants |
| Race (NIH/OMB) Race Black or African American | 9 Participants |
| Race (NIH/OMB) Race More than one race | 6 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race White | 111 Participants |
| Sex: Female, Male Sex Female | 78 Participants |
| Sex: Female, Male Sex Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 130 |
| other Total, other adverse events | 0 / 131 | 0 / 130 |
| serious Total, serious adverse events | 14 / 131 | 17 / 130 |
Outcome results
Primary
Cumulative IOP Spike Rate From Safety Endpoint
The cumulative IOP spike rate is the proportion of eyes that experienced at least one IOP spike within each arm during the 3-month postoperative period. The status of the cumulative IOP spike is either 'Yes, Spike' or 'No, Non-Spike,' and the results of the cumulative IOP spike rate are presented in percentage. For this outcome measure, subjects have been analyzed as per treated received, which gives investigational OVD of 131 participants and 131 eyes treated; and control OVD of 130 participants and 130 eyes treated.
Time frame: 3-month postoperative
Population: Percentage cumulative IOP spike rate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational OVD | Cumulative IOP Spike Rate From Safety Endpoint | 7.54 Percentage |
| Control OVD | Cumulative IOP Spike Rate From Safety Endpoint | 7.46 Percentage |
95% CI: [-5.07, 5.23]Mixed Models Analysis
Primary
ECC Percent Change From Effectiveness Endpoint
The success criterion for the primary effectiveness endpoint was met (modified ITT Population) as the investigational device (HEALON EndoCoat OVD) demonstrated non-inferiority to the control device (HEALON EndoCoat OVD) with respect to the difference in mean ECC percent change. For this outcome measure, subjects have been analyzed as per planned randomization schema, which gives investigational OVD of 130 participants and 130 eyes randomized; and control OVD of 131 participants and 131 eyes randomized.
Time frame: 3-month postoperative
Population: ECC Change in Percentage in Negative number value
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational OVD | ECC Percent Change From Effectiveness Endpoint | -9.03 Percentage Change | Standard Error 1.31 |
| Control OVD | ECC Percent Change From Effectiveness Endpoint | -8.53 Percentage Change | Standard Error 1.27 |
95% CI: [-3.37, 2.37]Mixed Models Analysis