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

Not Applicable

Completed

Conditions: Cataract

Interventions: Device: ReSTOR Toric

Registration Number: NCT03856944

Lead Sponsor: Gainesville Eye Associates

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReSTOR Toric	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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