Clinical trial NCT01510717: Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]
Official title: Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Intraocular Lens
Monofocal
Multifocal
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-01-16
Enrollment: 409
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180
timeFrame: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation
measure: Photopic Contrast Sensitivity Without Glare at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Photopic Contrast Sensitivity With Glare at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Mesopic Contrast Sensitivity Without Glare at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Mesopic Contrast Sensitivity With Glare at Day 120-180
timeFrame: Day 120-180 from second eye implantation
Secondary outcomes:
measure: Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
timeFrame: Day 120-180 from second eye implantation
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Magda Michna, PhD
role: STUDY_DIRECTOR
References:
citation: 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.