Clinical trial NCT01192321: Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation
Official title: Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cataract
Keywords: intraocular lens
Toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Uncorrected Distance Visual Acuity
timeFrame: 6 Months After Surgery
measure: Spectacle Independence
timeFrame: 6 Months After Surgery
Secondary outcomes:
measure: Vision-related Quality of Life
timeFrame: 6 Months After Surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Contact Alcon Call Center for Trial Locations
Study officials:
References: