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

NCT01510717 | Completed Results

• 1 other identifier: C-10-016
• Study Type: interventional
• Target: 409
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataracts

Keywords

Intraocular Lens; Monofocal; Multifocal

Outcome Measures

Primary Outcomes (6)

• Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180

  Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. 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. This analysis was prespecified for the primary eye.

  Day 120-180 from second eye implantation

• Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180

  Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.

  Day 0 first operative eye visit, up to Day 120-180 from second eye implantation

• Photopic Contrast Sensitivity Without Glare at Day 120-180

  Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

  Day 120-180 from second eye implantation

• Photopic Contrast Sensitivity With Glare at Day 120-180

  Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

  Day 120-180 from second eye implantation

• Mesopic Contrast Sensitivity Without Glare at Day 120-180

  Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

  Day 120-180 from second eye implantation

• Mesopic Contrast Sensitivity With Glare at Day 120-180

  Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

  Day 120-180 from second eye implantation

Secondary Outcomes (4)

• Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180

  Day 120-180 from second eye implantation

• Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180

  Day 120-180 from second eye implantation

• Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180

  Day 120-180 from second eye implantation

• Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180

  Day 120-180 from second eye implantation

Study Arms (2)

Multifocal IOL

EXPERIMENTAL

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

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

Monofocal IOL

ACTIVE COMPARATOR

AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation

Device: AcrySof® IQ Monofocal IOL Model SN60WF

Interventions

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

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

Multifocal IOL

AcrySof® IQ Monofocal IOL Model SN60WF DEVICE

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

Monofocal IOL

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• 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.

  PMID: 32600261 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Magda Michna, PhD
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Magda Michna, PhD

  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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 16, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 27, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-05