Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

Cataracts Clinical Trial

Official title:

Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05575063
• Other study ID #: VSCO-110-LOKE
• Status: Completed
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: February 2024
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• Investigational Healon Endocoat
Ophthalmic Viscoelastic device
• Control Healon EndoCoat
Ophthalmic Viscoelastic device

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	up to 3-month follow-up
Primary	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.	up to 3-month follow-up