Presbyopia-Correcting Intraocular Lenses (IOLs)

Alcon

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: Crystalens HD; Device: Crystalens AO; Device: ReSTOR +3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00963560

M09-008

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 Presbyopia-Correcting Intraocular Lenses (IOLs).

Enrollment: 132 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 preoperative astigmatism by Keratometry 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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132 participants in 3 patient groups

ReSTOR +3

Experimental group

Description:

Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)

Treatment:

Device: ReSTOR +3

Crystalens HD

Active Comparator group

Description:

Bilateral implantation of Crystalens HD Intraocular Lens (IOL)

Treatment:

Device: Crystalens HD

Crystalens AO

Active Comparator group

Description:

Bilateral implantation of Crystalens AO Intraocular Lens (IOL)

Treatment:

Device: Crystalens AO