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

NCT01192321 | Terminated Phase 4

• 1 other identifier: M09-047
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

intraocular lens; Toric

Outcome Measures

Primary Outcomes (2)

• 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

• Spectacle Independence

  Spectacle Independence (the ability of the patient to go without corrective lenses) measured by a subjective patient questionnaire.

  6 Months After Surgery

Secondary Outcomes (1)

• Vision-related Quality of Life

  6 Months After Surgery

Study Arms (2)

Toric T3 - T9

EXPERIMENTAL

Bilateral implantation of a Toric intraocular lens (IOL) models T3, T4, T5, T6, T7, T8 or T9

Device: Toric T3 - T9

Monofocal

ACTIVE COMPARATOR

Bilateral implantation of a monofocal intraocular lens (IOL) model with no toric component.

Device: Monofocal

Interventions

Toric T3 - T9 DEVICE

Bilateral implantation of Alcon AcrySof Toric Intraocular Lens (IOL) models SN60T3 through SN60T9 following cataract removal.

Toric T3 - T9

Monofocal DEVICE

Bilateral implantation of any monofocal Intraocular Lens (IOL) following cataract removal.

Monofocal

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Paris, 75014, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 22, 2012

Record last verified: 2012-10

Locations

FR (1)