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

April 20, 2020 updated by: Clinical Research Consultants, Inc.

Influence of DisCoVisc OVD on Intraoperative Aberrometry Readings for Intraocular Lens (IOL) Calculations After Cataract Extraction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90067
        • Advanced Vision Care
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Cleveland Eye Clinic
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • The Eye Institute of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 Day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Research Consultants, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AVC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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