Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation
This study has been terminated.
(Business decision to close study based on low enrollment)
Information provided by (Responsible Party):
First received: August 30, 2010
Last updated: October 19, 2012
Last verified: October 2012
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.
Device: Toric T3 - T9
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
||Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation
Primary Outcome Measures:
- Uncorrected Distance Visual Acuity [ Time Frame: 6 Months After Surgery ] [ Designated as safety issue: No ]
Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
- Spectacle Independence [ Time Frame: 6 Months After Surgery ] [ Designated as safety issue: No ]
Spectacle Independence (the ability of the patient to go without corrective lenses) measured by a subjective patient questionnaire.
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
Experimental: Toric T3 - T9
Bilateral implantation of a Toric intraocular lens (IOL) models T3, T4, T5, T6, T7, T8 or T9
Device: Toric T3 - T9
Bilateral implantation of Alcon AcrySof Toric Intraocular Lens (IOL) models SN60T3 through SN60T9 following cataract removal.
Active Comparator: Monofocal
Bilateral implantation of a monofocal intraocular lens (IOL) model with no toric component.
Bilateral implantation of any monofocal Intraocular Lens (IOL) following cataract removal.
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192321
|Contact Alcon Call Center for Trial Locations
|Paris, France, 75014 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 30, 2010
||October 19, 2012
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Keywords provided by Alcon Research:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014