Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings

• ClinicalTrials.gov Identifier: NCT03751033
• Recruitment Status: Completed
• First Posted: November 23, 2018
• Last Update Posted: April 21, 2020
• Sponsor: Clinical Research Consultants, Inc.
• Information provided by (Responsible Party): Clinical Research Consultants, Inc.

Study Description

Brief Summary:

The purpose of the study is to develop a nomogram that correlates intraoperative, aphakic refraction measurements when the anterior chamber is pressurized with either balanced salt solution (BSS) or DisCoVisc; and to understand how suggested IOL power selection may differ.

Condition or disease	Intervention/treatment	Phase
Cataract	Device: BSS; Device: DiscoVisc	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Influence of DisCoVisc OVD on Intraoperative Aberrometry Readings for Intraocular Lens (IOL) Calculations After Cataract Extraction
• Actual Study Start Date: September 7, 2018
• Actual Primary Completion Date: January 6, 2020
• Actual Study Completion Date: January 6, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: BSS and DisCoVisc; Following lens removal and removal of all OVD from the anterior chamber during cataract surgery, the chamber will be filled with BSS and the main incision hydrated with BSS. Intraoperative aberrometry, using the Optiwave® Refractive Analysis with VerifEye+ (ORA), will be performed, and the results of aphakic refraction and suggested IOL power will be recorded in triplicate. Immediately following, the BSS will be replaced with DisCoVisc; and, triplicate readings will be measured under the same conditions.

Device: BSS; Intraoperative aberrometry measurements for BSS will be performed.; Device: DiscoVisc; Intraoperative aberrometry measurements for DiscoVisc will be performed.

Outcome Measures

Primary Outcome Measures :

1. Differences in aphakic refractive measurements with BSS versus DiscoVisc [ Time Frame: 1 Day ]
   The differences in spherical equivalents will be evaluated using a nonparametric approach (Friedman chi-square test).

Secondary Outcome Measures :

1. Difference between suggested IOL power selections with BSS versus DiscoVisc [ Time Frame: 1 Day ]
   The differences in IOL power will be evaluated using a nonparametric approach (Friedman chi-square test).

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• In good general health
• Between 22 and 95 years of age and diagnosed with cataract(s)
• Able to comprehend and sign a written statement of informed consent for participation in the study, including HIPAA
• Undergoing cataract extraction surgery with an Alcon SN6 platform intraocular lens implantation into the posterior chamber
• Clear intraocular media, other than cataract
• Potential postoperative best-corrected visual acuity (BSCVA) of 20/30 or better
• Axial length of ≥ 22.00 and ≤ 28.00

Exclusion Criteria:

• Concurrent participation in another investigational drug or device study or participation in another study within the last 30 days prior to Screening
• Has had prior laser vision correction and/or corneal surgery
• Has a complication during surgery unrelated to ORA use
• Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma or posterior capsule defects
• History of infectious corneal disease (e.g., herpes simplex, herpes zoster, etc.) or other conditions which may result in corneal scarring
• Significant central opacity/scar
• Irregular astigmatism based upon investigator judgment
• Inability to achieve keratometric stability
• Will require another procedure, such as iris hooks, use of a Malyugin ring or insertion of a capsular tension ring during surgery
• Will require significant sedation during surgery
• Subject who is unable to maintain adequate fixation for image capture with ORA
• Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism, including, but not limited to the following: corneal leukoma and pterygium
• Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
• May reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy)
• Amblyopia
• Corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
• Endothelial disease that may potentially affect visual outcome
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 20/30 and/or that the investigator deems would interfere with acquiring images or determining a precise postoperative refraction
• Shallow anterior chamber, not due to swollen cataract
• History of retinal detachment or macular pucker
• Ocular conditions such as keratoconus, forme fruste keratoconus or recurrent erosion syndrome that may predispose the subject to complications
• Microphthalmos
• Previous corneal transplant
• Recurrent severe anterior or posterior segment inflammation of unknown etiology
• Rubella or traumatic cataract
• Iris neovascularization
• Uncontrolled glaucoma or glaucoma with visual field defects
• Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
• Ectopic pupil
• Pupil abnormalities (nonreactive, fixed pupils; abnormally shaped pupils)
• Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) likely, in the opinion of the Investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery
• Aniridia
• Optic nerve atrophy
• Uncontrolled systemic disease or acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, multiple sclerosis, lupus, hepatitis, rheumatoid arthritis, etc.)
• Uncontrolled/poorly controlled diabetes
• Uncontrolled ocular hypertension (≥ 22 mmHg)
• Active intraocular inflammation or recurrent ocular inflammatory \ condition (e.g., recurrent or persistent iritis, iridocyclitis, posterior uveitis, etc.)
• Use of systemic or ocular medications that may affect vision
• Recent ocular trauma that is not resolved/stable or may affect visual outcomes
• Previous ocular surgery such as pterygium removal, tear duct surgery, radial keratectomy, etc.
• Pregnant women, nursing women and subjects suspected of being pregnant
• Subjects who, in the judgment of the investigator or sub-investigator, are inadequate for the study

Contacts and Locations

Locations

United States, California

Advanced Vision Care

Los Angeles, California, United States, 90067

United States, Ohio

Cleveland Eye Clinic

Brecksville, Ohio, United States, 44141

United States, Utah

The Eye Institute of Utah

Salt Lake City, Utah, United States, 84107

Sponsors and Collaborators

Clinical Research Consultants, Inc.

Investigators

• Principal Investigator: Nicole Fram, MD; Advanced Vision Care

More Information

• Responsible Party: Clinical Research Consultants, Inc.
• ClinicalTrials.gov Identifier: NCT03751033
• Other Study ID Numbers: AVC-001
• First Posted: November 23, 2018
• Last Update Posted: April 21, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Clinical Research Consultants, Inc.:

Cataract Extraction

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases