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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)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01192321
First received: August 30, 2010
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cataract
 Device: Toric T3 - T9
Device: Monofocal
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation

Resource links provided by NLM:

MedlinePlus related topics: Cataract Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

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:
  • Vision-related Quality of Life [ Time Frame: 6 Months After Surgery ] [ Designated as safety issue: No ]
    Vision related quality of life as measured by a subjective subject questionnaire.


Enrollment: 9
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Device: Monofocal
Bilateral implantation of any monofocal Intraocular Lens (IOL) following cataract removal.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192321

Locations
France
Contact Alcon Call Center for Trial Locations
Paris, France, 75014
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01192321     History of Changes
Other Study ID Numbers: M09-047
Study First Received: August 30, 2010
Last Updated: October 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Alcon Research:
intraocular lens
Toric

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013