NCT03856944CompletedNot Applicable
Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
Gainesville Eye Associates2 sites in 1 country29 target enrollmentStarted: October 5, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Residual Refractive Cylinder
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Residual Refractive Cylinder
Time Frame: 3 months
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation
Secondary Outcomes
- Binocular Uncorrected Distance Visual Acuity(3 months)
- IOL Orientation(3 months)
- Monocular Uncorrected Near Visual Acuity(3 months)
- Monocular Uncorrected Intermediate Visual Acuity(3 months)
- Binocular Uncorrected Intermediate Visual Acuity(3 months)
- Binocular Best-corrected Distance Visual Acuity(3 months)
- Binocular Best Distance-corrected Intermediate Visual Acuity(3 months)
- Binocular Best Distance-corrected Near Visual Acuity(3 months)
- Subjective Visual Quality(3 months)
- Monocular Best Distance-corrected Intermediate Visual Acuity(3 months)
- Binocular Uncorrected Near Visual Acuity(3 months)
- Binocular Best Distance-corrected Defocus Curve(3 months)
- Monocular Uncorrected Distance Visual Acuity(3 months)
- Monocular Best Corrected Distance Visual Acuity(3 months)
- Monocular Best Distance-corrected Near Visual Acuity(3 months)
- Binocular Uncorrected Defocus Curve.(3 months)
Investigators
Clayton Blehm, MD
Principal investigator
Gainesville Eye Associates
Study Sites (2)
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