Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation
NCT ID: NCT01192321
Last Updated: 2012-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
9 participants
INTERVENTIONAL
2010-06-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Toric T3 - T9
Bilateral implantation of a Toric intraocular lens (IOL) models T3, T4, T5, T6, T7, T8 or T9
Toric T3 - T9
Bilateral implantation of Alcon AcrySof Toric Intraocular Lens (IOL) models SN60T3 through SN60T9 following cataract removal.
Monofocal
Bilateral implantation of a monofocal intraocular lens (IOL) model with no toric component.
Monofocal
Bilateral implantation of any monofocal Intraocular Lens (IOL) following cataract removal.
Interventions
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Toric T3 - T9
Bilateral implantation of Alcon AcrySof Toric Intraocular Lens (IOL) models SN60T3 through SN60T9 following cataract removal.
Monofocal
Bilateral implantation of any monofocal Intraocular Lens (IOL) following cataract removal.
Eligibility Criteria
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Inclusion Criteria
* are willing and able to attend postoperative examinations per protocol schedule;
* are ≥ 21 years of age, of either gender and any race;
* have bilateral, age related, cataracts;
* have planned cataract removal via phacoemulsification with implantation of an intraocular lens (IOL);
* are available to undergo second eye surgery within 6 weeks of the first eye surgery;
* are in good ocular health, with the exception of cataracts;
* are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof Toric and monofocal package inserts: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism and color vision deficiencies.
* have regular corneal astigmatism;
* qualify for bilateral AcrySof Toric IOLs on the AcrySof Toric Calculator (www.acrysoftoriccalculator.com)
* are able to obtain pupil dilation ≥ 5.0 mm
* are able to read and understand one of the following languages: Dutch, French, German
Exclusion Criteria
* abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens
* planned multiple procedures during cataract/IOL implantation surgery
* planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure prior to or during the course of the study
* an ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, amblyopia, etc.)
* pregnant, lactating or planning pregnancy during course of study. Subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results. Data will be collected on the CRF as observations.
21 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Locations
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Contact Alcon Call Center for Trial Locations
Paris, , France
Countries
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Other Identifiers
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M09-047
Identifier Type: -
Identifier Source: org_study_id