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CataractNCT03751033

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

A study testing BSS and DiscoVisc in people with Cataract, run by Clinical Research Consultants, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 95 years
Conditions the study is for
Cataract
What is being tested?
BSS and DiscoVisc
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
7 Sep 2018to 6 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 42Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Cleveland Eye Clinic

    Brecksville, Ohio, 44141

  • Advanced Vision Care

    Los Angeles, California, 90067

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107

Other trials in United States

About this study

Official title: 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.

Conditions
Cataract
Being tested
BSS, DiscoVisc
Keywords
Cataract Extraction
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BSSDevice

    Intraoperative aberrometry measurements for BSS will be performed.

  • DiscoViscDevice

    Intraoperative aberrometry measurements for DiscoVisc will be performed.

Study groups in NCT03751033
Study groupRoleWhat they receive
BSS and DisCoViscExperimentalFollowing 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.
Receives: Device: BSS; Device: DiscoVisc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in aphakic refractive measurements with BSS versus DiscoVisc

    The differences in spherical equivalents will be evaluated using a nonparametric approach (Friedman chi-square test).

    Measured: 1 Day

Secondary outcomes (1)

  1. Difference between suggested IOL power selections with BSS versus DiscoVisc

    The differences in IOL power will be evaluated using a nonparametric approach (Friedman chi-square test).

    Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study start7 Sep 2018
  3. Primary completion6 Jan 2020
  4. Study completion6 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03751033
Sponsor's protocol ID
AVC-001
Status last verified
Apr 2020
First submitted
24 Oct 2018
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BSS and DiscoVisc in people with Cataract, run by Clinical Research Consultants, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in aphakic refractive measurements with BSS versus DiscoVisc (time frame: 1 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03751033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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