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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510717
• Other study ID #: C-10-016
• Status: Completed
• Phase: N/A
• First received: January 12, 2012
• Last updated: May 8, 2015
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Previous refractive surgery

• Inflammation or edema of the cornea

• Optic nerve atrophy

• Pregnancy

• Current participation in another investigational drug or device study

• Other protocol-defined exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataracts

Intervention

Device:
• 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
• AcrySof® IQ Monofocal IOL Model SN60WF
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180	VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. 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. This analysis was prespecified for the primary eye.	Day 120-180 from second eye implantation	No
Secondary	Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180	VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. 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. This analysis was prespecified for the primary eye.	Day 120-180 from second eye implantation	No
Secondary	Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180	Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?"	Day 120-180 from second eye implantation	No
Secondary	Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180	Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?"	Day 120-180 from second eye implantation	No