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

NCT03856944 | Completed Results FDA Device

• 1 other identifier: CB-18-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Keywords

Astigmatism; intraocular lens; multifocal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Monocular Uncorrected Near Visual Acuity

  3 months

• Monocular Uncorrected Distance Visual Acuity

  3 months

• Monocular Uncorrected Intermediate Visual Acuity

  3 months

• Monocular Best Corrected Distance Visual Acuity

  3 months

• Monocular Best Distance-corrected Intermediate Visual Acuity

  3 months

Study Arms (1)

ReSTOR Toric

EXPERIMENTAL

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

Interventions

ReSTOR Toric DEVICE

ReSTOR Toric bilateral IOL implantation

Also known as: ReSTOR +2.5 Toric, ReSTOR +3.0 Toric

ReSTOR Toric

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gainesville Eye Associates: lead
• SiV Consulting: collaborator

Study Sites (1)

Gainesville Eye Associates

Gainesville, Georgia, 30501, United States

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Clayton Blehm, MD
• Organization: Gainesville Eye Associates

claytonblehm@gmail.com

770-532-4444

Study Officials

• Clayton G Blehm, MD

  Gainesville Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This study is a prospective, single center, open clinical trial to collect normative performance data.

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: February 27, 2019
• Study Start: October 5, 2018
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: August 6, 2021
• Results First Posted: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)