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

Cataract Clinical Trial

Official title:

Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01192321
• Other study ID #: M09-047
• Status: Terminated
• Phase: Phase 4
• First received: August 30, 2010
• Last updated: October 19, 2012
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Contact Alcon Call Center for Trial Locations	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Distance Visual Acuity	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.	6 Months After Surgery	No
Primary	Spectacle Independence	Spectacle Independence (the ability of the patient to go without corrective lenses) measured by a subjective patient questionnaire.	6 Months After Surgery	No
Secondary	Vision-related Quality of Life	Vision related quality of life as measured by a subjective subject questionnaire.	6 Months After Surgery	No