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

The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: ReSTOR Toric

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Gainesville Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ReSTOR Toric; 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.	Device: ReSTOR Toric; ReSTOR Toric bilateral IOL implantation; Other Names: ReSTOR +2.5 Toric; ReSTOR +3.0 Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Refractive Cylinder	Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Uncorrected Near Visual Acuity	Monocular uncorrected near visual acuity measuring in logMAR	3 months
Monocular Uncorrected Distance Visual Acuity	Monocular uncorrected distance visual acuity measured in logMAR notation	3 months
Monocular Uncorrected Intermediate Visual Acuity	Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution)	3 months
Monocular Best Corrected Distance Visual Acuity	Monocular best corrected distance visual acuity measured in logMAR notation	3 months
Monocular Best Distance-corrected Intermediate Visual Acuity	Monocular best distance-corrected intermediate visual acuity in logMAR notation	3 months
Monocular Best Distance-corrected Near Visual Acuity	Monocular best distance-corrected near visual acuity measured in logMAR notation	3 months
Binocular Uncorrected Near Visual Acuity	Binocular uncorrected near (40cm) visual acuity measured in logMAR notation	3 months
Binocular Uncorrected Distance Visual Acuity	Binocular uncorrected distance visual acuity measured in logMAR notation	3 months
Binocular Uncorrected Intermediate Visual Acuity	Binocular uncorrected intermediate (60cm) visual acuity	3 months
Binocular Best-corrected Distance Visual Acuity	Binocular best-corrected distance visual acuity measured in logMAR notation	3 months
Binocular Best Distance-corrected Intermediate Visual Acuity	Binocular best distance-corrected intermediate (60cm) visual acuity	3 months
Binocular Best Distance-corrected Near Visual Acuity	Binocular best distance-corrected near (40cm) visual acuity	3 months
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.	3 months
Binocular Best Distance-corrected Defocus Curve	Binocular best distance-corrected defocus curve.	3 months
Binocular Uncorrected Defocus Curve.	Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments	3 months
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.	3 months

Collaborators and Investigators

• Sponsor: Gainesville Eye Associates
• Collaborators: SiV Consulting
• Investigators: Principal Investigator: Clayton G Blehm, MD, Gainesville Eye Associates

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 5, 2018
• Primary Completion (ACTUAL): November 18, 2019
• Study Completion (ACTUAL): November 18, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: intraocular lens; Astigmatism; multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CB-18-001

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