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N/A N=29 Treatment

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

Cataract

Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Residual Refractive Cylinder — 0.02 diopters

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ReSTOR Toric (Device)
Age
Adult, Older Adult · 30+ yrs
Sex
All
Sponsor
Gainesville Eye Associates
Primary completion
Nov 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Residual Refractive Cylinder
0.02
SECONDARY
Monocular Uncorrected Near Visual Acuity
0.12
SECONDARY
Monocular Uncorrected Distance Visual Acuity
0.04
SECONDARY
Monocular Uncorrected Intermediate Visual Acuity
0.06
SECONDARY
Monocular Best Corrected Distance Visual Acuity
.04
SECONDARY
Monocular Best Distance-corrected Intermediate Visual Acuity
.06
SECONDARY
Monocular Best Distance-corrected Near Visual Acuity
.11
SECONDARY
Binocular Uncorrected Near Visual Acuity
0.01
SECONDARY
Binocular Uncorrected Distance Visual Acuity
-0.01
SECONDARY
Binocular Uncorrected Intermediate Visual Acuity
-0.02
SECONDARY
Binocular Best-corrected Distance Visual Acuity
-0.03
SECONDARY
Binocular Best Distance-corrected Intermediate Visual Acuity
-0.06
SECONDARY
Binocular Best Distance-corrected Near Visual Acuity
0.01
SECONDARY
IOL Orientation
56
SECONDARY
Binocular Best Distance-corrected Defocus Curve
.24; .07; -.01; .55; .40; .28
SECONDARY
Binocular Uncorrected Defocus Curve.
.22; .07; -.01; .55; .41; .29
SECONDARY
Subjective Visual Quality
32; 22; 0

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03856944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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