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Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

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Alcon

Status and phase

Terminated
Phase 4

Conditions

Cataract

Treatments

Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3

Study type

Interventional

Funder types

Industry

Identifiers

NCT00710905
ALCONsur002.08

Details and patient eligibility

About

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.

Enrollment

50 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion criteria

  • Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
  • All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

ReSTOR
Experimental group
Description:
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Treatment:
Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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