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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:
ClinicalTrials.gov Identifier:
NCT01192321
First Posted: September 1, 2010
Last Update Posted: October 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  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 (Participant, 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:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Uncorrected Distance Visual Acuity [ Time Frame: 6 Months After Surgery ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192321


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01192321     History of Changes
Other Study ID Numbers: M09-047
First Submitted: August 30, 2010
First Posted: September 1, 2010
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by Alcon Research:
intraocular lens
Toric

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases


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