Status:
COMPLETED
Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
Lead Sponsor:
Gainesville Eye Associates
Collaborating Sponsors:
SiV Consulting
Conditions:
Cataract
Eligibility:
All Genders
30+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2019
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03856944
Start Date
October 5 2018
End Date
November 18 2019
Last Update
August 6 2021
Active Locations (1)
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1
Gainesville Eye Associates
Gainesville, Georgia, United States, 30501