Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)

Cataract Clinical Trial

Official title:

Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782676
• Other study ID #: VSCO-109-HLN5
• Status: Completed
• Phase: N/A
• Start date: June 21, 2016
• Est. completion date: May 4, 2017

Study information

• Verified date: May 2018
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.

Description:

This study will include only subjects undergoing bilateral, primary, cataract extraction and intraocular lens (IOL) implantation and who meet all of the study inclusion and exclusion criteria in both eyes. Subjects who meet the inclusion/exclusion criteria and agree to participate will be randomly assigned to receive the investigational OVD in one eye and the currently-available (i.e., commercial) OVD in the fellow eye (control). Thus, a single group of subjects will provide data for both the investigational OVD and the control OVD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Minimum 22 years of age

• Cataracts for which extraction and posterior IOL implantation have been planned for 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 visual outcomes or increase risk to the subject

• Prior corneal refractive (LASIK- laser-assisted in situ keratomileusis, LASEK-laser-assisted sub-epithelial keratectomy, RK- radial keratectomy, PRK- photorefractive keratectomy, etc.) or intraocular surgery

• 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

• 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.

• 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

• 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)

• 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 lowest value 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 45 days prior to preoperative visit, in any other clinical trial

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Investigational Healon5 OVD
ophthalmic viscosurgical device
• Healon5 OVD
ophthalmic viscosurgical device

Locations

Country	Name	City	State
United States	Empire Eye & Laser Center	Bakersfield	California
United States	Cape Coral Eye Center	Cape Coral	Florida
United States	Scott & Christie and Associates	Cranberry Township	Pennsylvania
United States	Loden Vision Center	Goodlettsville	Tennessee
United States	Whitsett Vision Group	Houston	Texas
United States	Clarus Eye Centre	Lacey	Washington
United States	Parkhurst NuVision	San Antonio	Texas
United States	Katzen Eye Care & Laser Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively	The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.	3 months
Primary	Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively	The mean percent ECC change with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 5%.	3 months
Secondary	Ocular Serious Adverse Events (SAE)	Ocular serious and/or device related adverse event rates was be tabulated with the frequency and proportion of eyes with these events reported over time and cumulatively by OVD group.; * in the results table denotes SAEs determined to be device-related	3 months
Secondary	Mean Change in IOP From Baseline	The mean change in IOP from baseline for both OVD groups over time at the 6 hour, 1 day, 1 week, 1 month, and 3 month postoperative time points are presented.	3 months
Secondary	Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively	The rate of IOP spike 30 mmHg or greater at 6 hour, 1 day, 1 week, 1 month and 3 months postoperatively was tabulated with frequency and proportion by OVD group.	3 months
Secondary	Grade of Inflammation: Epithelial Edema	The grades of inflammation for epithelial edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.	Upto 3 months
Secondary	Grade of Inflammation: Stromal Edema	The grades of inflammation for stromal edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.	Upto 3 months
Secondary	Grade of Inflammation: Cells	The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.	Upto 3 months
Secondary	Grade of Inflammation: Flare	The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.	Upto 3 months
Secondary	Grade of Inflammation: Anterior Synechiae	The grades of inflammation for Anterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.	Upto 3 months
Secondary	Grade of Inflammation: Posterior Synechiae	The grades of inflammation for Posterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.	Upto 3 Months
Secondary	Grade of Inflammation: Fibrin Presence	The grades of inflammation for Fibrin Presence was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.	Upto 3 Months