Clinical trial NCT01290068: Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
Official title: Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Intraocular Lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-02-04
Enrollment: 208
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 assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.

Detailed description: This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.

Eligibility criteria: Inclusion Criteria:

* Willing and able to understand and sign an Informed Consent;
* Willing and able to attend post-operative examinations as per protocol schedule;
* Diagnosis of bilateral, age-related cataracts;
* Planned cataract removal via phacoemulsification with implantation of an IOL;
* Available to undergo second eye surgery within 6 weeks of the first eye surgery;
* Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
* No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
* Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
* Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery and/or reshaping;
* Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
* Pregnant, lactating, or planning pregnancy during the course of study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Classified as Responders
timeFrame: Month 6 after second eye implantation
measure: Proportion of Participants Reporting Spectacle Independence at All Distances
timeFrame: Month 6 after second eye implantation
measure: Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)
timeFrame: Month 6 after second eye implantation
Secondary outcomes:
measure: Median Total Spectacle Cost Prior to Any Reimbursement
timeFrame: Month 6 after second eye implantation
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Brand Lead, Surgical, Global Medical Affairs
role: STUDY_DIRECTOR
References: