A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

Alcon

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: Tecnis MF; Device: ReSTOR +3

Study type: Interventional

Funder types: Industry

Identifiers

NCT01166971

M09-050

Details and patient eligibility

About

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Enrollment: 65 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with bilateral cataracts
• candidate for presbyopic lens

Exclusion criteria

• >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
• pre-existing conditions that could skew the results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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65 participants in 2 patient groups

ReSTOR +3

Experimental group

Description:

Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction

Treatment:

Device: ReSTOR +3

Tecnis MF

Active Comparator group

Description:

Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction

Treatment:

Device: Tecnis MF