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Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReSTOR Toric
Sponsored by
Gainesville Eye Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Astigmatism, intraocular lens, multifocal

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in the eligible eye.

  • Bilateral visually-significant cataracts
  • Willing and able to provide written informed consent for participation in the study.
  • Willing and able to comply with scheduled visits and other study procedures.
  • have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
  • Regular corneal astigmatism of 1.00D to 2.50D in both eyes
  • Potential postoperative acuity of 20/25 or better

Exclusion Criteria:

  • If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

    • Irregular astigmatism (e.g. keratoconus)
    • Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy (EBMD), Fuch's dystrophy, etc.)
    • Monocular status (e.g. amblyopia)
    • Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), lamellar keratoplasty)
    • Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
    • Moderate-to-advanced glaucoma
    • Strabismus
    • Use of arcuate incisions for astigmatism management at the time of surgery
    • Diabetic retinopathy
    • Macular pathology (e.g. age-related macular degeneration, epiretinal membrane, etc.)
    • History of retinal detachment
    • Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
    • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Sites / Locations

  • Gainesville Eye Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ReSTOR Toric

Arm Description

Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation.

Outcomes

Primary Outcome Measures

Residual Refractive Cylinder
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation

Secondary Outcome Measures

Monocular Uncorrected Near Visual Acuity
Monocular uncorrected near visual acuity measuring in logMAR
Monocular Uncorrected Distance Visual Acuity
Monocular uncorrected distance visual acuity measured in logMAR notation
Monocular Uncorrected Intermediate Visual Acuity
Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution)
Monocular Best Corrected Distance Visual Acuity
Monocular best corrected distance visual acuity measured in logMAR notation
Monocular Best Distance-corrected Intermediate Visual Acuity
Monocular best distance-corrected intermediate visual acuity in logMAR notation
Monocular Best Distance-corrected Near Visual Acuity
Monocular best distance-corrected near visual acuity measured in logMAR notation
Binocular Uncorrected Near Visual Acuity
Binocular uncorrected near (40cm) visual acuity measured in logMAR notation
Binocular Uncorrected Distance Visual Acuity
Binocular uncorrected distance visual acuity measured in logMAR notation
Binocular Uncorrected Intermediate Visual Acuity
Binocular uncorrected intermediate (60cm) visual acuity
Binocular Best-corrected Distance Visual Acuity
Binocular best-corrected distance visual acuity measured in logMAR notation
Binocular Best Distance-corrected Intermediate Visual Acuity
Binocular best distance-corrected intermediate (60cm) visual acuity
Binocular Best Distance-corrected Near Visual Acuity
Binocular best distance-corrected near (40cm) visual acuity
IOL Orientation
Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp.
Binocular Best Distance-corrected Defocus Curve
Binocular best distance-corrected defocus curve.
Binocular Uncorrected Defocus Curve.
Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments
Subjective Visual Quality
Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and "Degree of Bother" aggregate statistics. Scored on a Rasch scale (0-100) where lower is better.

Full Information

First Posted
October 4, 2018
Last Updated
July 15, 2021
Sponsor
Gainesville Eye Associates
Collaborators
SiV Consulting
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1. Study Identification

Unique Protocol Identification Number
NCT03856944
Brief Title
Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
Official Title
Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2018 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gainesville Eye Associates
Collaborators
SiV Consulting

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.
Detailed Description
The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Astigmatism, intraocular lens, multifocal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a prospective, single center, open clinical trial to collect normative performance data.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReSTOR Toric
Arm Type
Experimental
Arm Description
Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation.
Intervention Type
Device
Intervention Name(s)
ReSTOR Toric
Other Intervention Name(s)
ReSTOR +2.5 Toric, ReSTOR +3.0 Toric
Intervention Description
ReSTOR Toric bilateral IOL implantation
Primary Outcome Measure Information:
Title
Residual Refractive Cylinder
Description
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Monocular Uncorrected Near Visual Acuity
Description
Monocular uncorrected near visual acuity measuring in logMAR
Time Frame
3 months
Title
Monocular Uncorrected Distance Visual Acuity
Description
Monocular uncorrected distance visual acuity measured in logMAR notation
Time Frame
3 months
Title
Monocular Uncorrected Intermediate Visual Acuity
Description
Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution)
Time Frame
3 months
Title
Monocular Best Corrected Distance Visual Acuity
Description
Monocular best corrected distance visual acuity measured in logMAR notation
Time Frame
3 months
Title
Monocular Best Distance-corrected Intermediate Visual Acuity
Description
Monocular best distance-corrected intermediate visual acuity in logMAR notation
Time Frame
3 months
Title
Monocular Best Distance-corrected Near Visual Acuity
Description
Monocular best distance-corrected near visual acuity measured in logMAR notation
Time Frame
3 months
Title
Binocular Uncorrected Near Visual Acuity
Description
Binocular uncorrected near (40cm) visual acuity measured in logMAR notation
Time Frame
3 months
Title
Binocular Uncorrected Distance Visual Acuity
Description
Binocular uncorrected distance visual acuity measured in logMAR notation
Time Frame
3 months
Title
Binocular Uncorrected Intermediate Visual Acuity
Description
Binocular uncorrected intermediate (60cm) visual acuity
Time Frame
3 months
Title
Binocular Best-corrected Distance Visual Acuity
Description
Binocular best-corrected distance visual acuity measured in logMAR notation
Time Frame
3 months
Title
Binocular Best Distance-corrected Intermediate Visual Acuity
Description
Binocular best distance-corrected intermediate (60cm) visual acuity
Time Frame
3 months
Title
Binocular Best Distance-corrected Near Visual Acuity
Description
Binocular best distance-corrected near (40cm) visual acuity
Time Frame
3 months
Title
IOL Orientation
Description
Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp.
Time Frame
3 months
Title
Binocular Best Distance-corrected Defocus Curve
Description
Binocular best distance-corrected defocus curve.
Time Frame
3 months
Title
Binocular Uncorrected Defocus Curve.
Description
Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments
Time Frame
3 months
Title
Subjective Visual Quality
Description
Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and "Degree of Bother" aggregate statistics. Scored on a Rasch scale (0-100) where lower is better.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in the eligible eye. Bilateral visually-significant cataracts Willing and able to provide written informed consent for participation in the study. Willing and able to comply with scheduled visits and other study procedures. have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) Regular corneal astigmatism of 1.00D to 2.50D in both eyes Potential postoperative acuity of 20/25 or better Exclusion Criteria: If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. Irregular astigmatism (e.g. keratoconus) Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy (EBMD), Fuch's dystrophy, etc.) Monocular status (e.g. amblyopia) Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), lamellar keratoplasty) Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) Moderate-to-advanced glaucoma Strabismus Use of arcuate incisions for astigmatism management at the time of surgery Diabetic retinopathy Macular pathology (e.g. age-related macular degeneration, epiretinal membrane, etc.) History of retinal detachment Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton G Blehm, MD
Organizational Affiliation
Gainesville Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gainesville Eye Associates
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models

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