NCT03751033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

October 24, 2018

Last Update Submit

April 20, 2020

Conditions

Cataract

Keywords

Cataract Extraction

Outcome Measures

Primary Outcomes (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).

    1 Day

Secondary Outcomes (1)

  • Difference between suggested IOL power selections with BSS versus DiscoVisc

    1 Day

Study Arms (1)

BSS and DisCoVisc

EXPERIMENTAL

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: BSSDevice: DiscoVisc

Interventions

BSSDEVICE

Intraoperative aberrometry measurements for BSS will be performed.

BSS and DisCoVisc
DiscoViscDEVICE

Intraoperative aberrometry measurements for DiscoVisc will be performed.

BSS and DisCoVisc

Eligibility Criteria

Age22 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Nicole Fram, MD

    Advanced Vision Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

November 23, 2018

Study Start

September 7, 2018

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)