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

NCT ID: NCT03856944

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-05
• Study Completion Date: 2019-11-18

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ReSTOR Toric

Intervention Type: DEVICE

ReSTOR Toric bilateral IOL implantation

Interventions

ReSTOR Toric

ReSTOR Toric bilateral IOL implantation

Intervention Type: DEVICE

Other Intervention Names

ReSTOR +2.5 Toric; ReSTOR +3.0 Toric

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

• 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SiV Consulting

OTHER

Sponsor Role: collaborator

Gainesville Eye Associates

OTHER

Sponsor Role: lead

Responsible Party

Clayton Blehm, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clayton G Blehm, MD

Role: PRINCIPAL_INVESTIGATOR

Gainesville Eye Associates

Locations

Gainesville Eye Associates

Gainesville, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CB-18-001

Identifier Type: -

Identifier Source: org_study_id