Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

NCT ID: NCT01424189

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 677 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.

Detailed Description

Participants 21 years and older within the targeted astigmatism range and in need of cataract extraction in both eyes were consented and randomized in a 2:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® Multifocal Toric IOL or the control AcrySof® ReSTOR® Multifocal IOL in both eyes. Each participant completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60 and binocular testing at Day 120-180 and Day 340-420/Visit 5 following the second implantation. The eye with the greater amount of astigmatism was implanted first (first operative eye). The second eye implant was intended to occur within 30 days after the first eye implant but not prior to 7 days after the first eye implant. Both eyes needed to qualify under inclusion/exclusion criteria at the preoperative visit. If the first eye was excluded during surgery, the second eye was not eligible. If the second eye was excluded during surgery, only the first eye was followed.

Conditions

Cataracts

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ReSTOR Toric IOL

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

Group Type: EXPERIMENTAL

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Intervention Type: DEVICE

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

ReSTOR IOL

AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation

Group Type: ACTIVE_COMPARATOR

AcrySof® ReSTOR® Multifocal IOL Model SA60D3

Intervention Type: DEVICE

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

Interventions

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

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

Intervention Type: DEVICE

AcrySof® ReSTOR® Multifocal IOL Model SA60D3

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

Intervention Type: DEVICE

Other Intervention Names

Models SND1T3, SND1T4, SND1T5, SND1T6

Eligibility Criteria

Inclusion Criteria

• Diagnosed with bilateral cataracts;
• Able to comprehend and sign a statement of informed consent;
• Calculated lens power and astigmatism within the available range;
• Willing and able to complete all required postoperative visits;
• Planned cataract removal by phacoemulsification;
• Potential postoperative visual acuity of 0.2 logMAR or better in both eyes;
• Preoperative astigmatism in both operative eyes as described in the clinical protocol; Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.
• Clear intraocular media other than cataract in study eyes;
• Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR in each eye;
• Pupil size greater than or equal to 6 mm after dilation;
• Able to undergo second eye surgery within 30 days of the first eye surgery;

Exclusion Criteria

• Significant irregular corneal aberration as demonstrated by corneal topography;
• Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism;
• Any inflammation or edema (swelling) of the cornea;
• Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.2 logMAR;
• Reasonably expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy);
• Previous corneal refractive surgery;
• Amblyopia;
• Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
• Diabetic retinopathy;
• Extremely shallow anterior chamber, not due to swollen cataract;
• Microphthalmos;
• Previous retinal detachment;
• Previous corneal transplant;
• Recurrent severe anterior or posterior segment inflammation of unknown etiology;
• Rubella or traumatic cataract;
• Iris neovascularization;
• Glaucoma (uncontrolled or controlled with medication);
• Aniridia;
• Optic nerve atrophy;
• Pregnancy;
• Current participation in another investigational drug or device study that may confound the results of this investigation;
• Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions, for the duration of the study;

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Expert Clinical Project Lead, GCRA, Surgical

Role: STUDY_DIRECTOR

Alcon Research

References

Williams JR, Kim HW, Crespi CM. Modeling observations with a detection limit using a truncated normal distribution with censoring. BMC Med Res Methodol. 2020 Jun 29;20(1):170. doi: 10.1186/s12874-020-01032-9.

Reference Type: DERIVED

PMID: 32600261 (View on PubMed)

Other Identifiers

C-09-036

Identifier Type: -

Identifier Source: org_study_id