Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

NCT01200511 | Completed Results

• 1 other identifier: M09-052
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

Conditions

Cataract

Keywords

intraocular lens; multifocal; toric

Outcome Measures

Primary Outcomes (3)

• Uncorrected Visual Acuity Across a Range of Distances at Month 6

  Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

  Month 6 from second eye implantation

• Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6

  VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

  Month 6 from second eye implantation

• Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6

  Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.

  Month 6 from second eye implantation

Secondary Outcomes (1)

• Patient Reported Outcomes at Month 6

  Month 6 from second eye implantation

Study Arms (1)

ReSTOR +3.0

EXPERIMENTAL

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation

Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Interventions

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL DEVICE

Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Also known as: Models SND1T3, SND1T4, SND1T5

ReSTOR +3.0

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign informed consent;
• Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
• Able to undergo second eye surgery within one month (30 days) of first eye surgery;
• Able to attend postoperative examinations per protocol schedule;
• Qualify for a AcrySof IQ Toric IOL in both eyes;
• Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
• Residual refractive cylinder of ≤0.5 D in both eyes;
• Good ocular health;

You may not qualify if:

• Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
• Amblyopia;
• Previous corneal surgery;
• Clinically significant corneal endothelial dystrophy;
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
• History of retinal detachment;
• Pregnant or planning to become pregnant during course of study;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Brand Lead, Surgical, Global Medical Affairs
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Brand Lead, Surgical, Global Medical Affairs

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 2, 2018
• Results First Posted: April 20, 2017

Record last verified: 2017-03