Contralateral ReSTOR / Monofocal or Phakic Eye

Alcon

Status and phase: Completed; Phase 4

Conditions: Cataracts

Treatments: Device: ReSTOR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731640

M07-012

Details and patient eligibility

About

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral operable cataract
• Candidate for presbyopic intraocular lens (IOL)

Exclusion criteria

• Ocular comorbidities compromising primary outcome
• Bilateral cataracts

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Monofocal

Active Comparator group

Description:

Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye

Treatment:

Device: ReSTOR

Phakic

Active Comparator group

Description:

Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending

Treatment:

Device: ReSTOR