Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

NCT ID: NCT01510717

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.

Detailed Description

Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.

Conditions

Cataracts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multifocal IOL

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation

Group Type: EXPERIMENTAL

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

Intervention Type: DEVICE

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

Monofocal IOL

AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation

Group Type: ACTIVE_COMPARATOR

AcrySof® IQ Monofocal IOL Model SN60WF

Intervention Type: DEVICE

Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Interventions

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

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

Intervention Type: DEVICE

AcrySof® IQ Monofocal IOL Model SN60WF

Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of bilateral cataracts
• Willing and able to complete all required postoperative visits
• Calculated lens power within the available supply range
• Planned cataract removal by phacoemulsification
• Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
• Preoperative astigmatism less than 1.0 diopter
• Clear intraocular media other than cataract in study eyes
• Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
• Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery

Exclusion Criteria

• Previous refractive surgery
• Inflammation or edema of the cornea
• Optic nerve atrophy
• Pregnancy
• Current participation in another investigational drug or device 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

Magda Michna, PhD

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-10-016

Identifier Type: -

Identifier Source: org_study_id