Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

NCT02176343 | Completed Results FDA Device

• 1 other identifier: C-14-005
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.

Conditions

Cataract; Presbyopia; Corneal Astigmatism

Keywords

Cataract; Intraocular lens; ACRYSOF IQ ReSTOR + 2.5 D Multifocal Toric IOL

Outcome Measures

Primary Outcomes (8)

• Mean Percent Reduction in Cylinder

  Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder \[defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder\], multiplied by 100%. One eye (primary eye) contributed to the analysis.

  Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

• Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D

  Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.

  Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

• Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D

  Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.

  Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

• Mean Uncorrected Distance Visual Acuity

  Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

  Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

• Mean Uncorrected Near Visual Acuity

  VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in 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. One eye (primary eye) contributed to the analysis.

  Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

• Mean Uncorrected Intermediate Visual Acuity

  VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in 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. One eye (primary eye) contributed to the analysis.

  Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

• Mean Best Corrected Distance Visual Acuity (BCDVA)

  VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in 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. One eye (primary eye) contributed to the analysis.

  Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

• Mean IOL Rotation

  Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.

  Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Study Arms (1)

ReSTOR Toric +2.5

EXPERIMENTAL

AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery

Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL

Interventions

AcrySof® IQ ReSTOR® +2.5 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: Model SV25T2, Model SV25T3, Model SV25T4, Model SV25T5

ReSTOR Toric +2.5

Eligibility Criteria

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

You may qualify if:

• Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);
• Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;
• Must complete a visit within 10 days after IOL implantation;
• Successful capsular bag implantation with no surgical complications;

You may not qualify if:

• IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;
• Ocular or intraocular infection or inflammation at the time of the preoperative visit;
• Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;
• Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;
• Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;
• Known history of Type 1 or 2 diabetes for more than 5 years;
• Any ocular or systemic co-morbidity at the preoperative visit;
• Pregnant at the preoperative visit or at the time of Postoperative Visit 2;
• Preoperative corneal astigmatism ≤ 0.50 D;
• Participation in another clinical study at the preoperative visit or at the time of the final study visit;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract; Presbyopia; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Clinical Project Lead, GCRA, Surgical
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, GCRA, Surgical

  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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: July 21, 2014
• Primary Completion: August 22, 2014
• Study Completion: August 22, 2014
• Last Updated: July 2, 2018
• Results First Posted: June 29, 2017

Record last verified: 2017-05