Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation

Alcon

Status and phase

Terminated

Phase 4

Conditions

Cataract

Treatments

Device: Monofocal

Device: Toric T3 - T9

Study type

Interventional

Funder types

Industry

Identifiers

NCT01192321

M09-047

Details and patient eligibility

About

The objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of AcrySof Toric Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of eyeglass purchased and patient vision-related quality of life.

Enrollment

9 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

are willing and able to understand and sign an informed consent;
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

previous corneal surgery and/or reshaping
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.