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

Sponsor
Alcon Research (Industry)
Overall Status
Terminated
CT.gov ID
NCT01192321
Collaborator
(none)
9
Enrollment
1
Location
2
Arms
6
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Toric T3 - T9
  • Device: Monofocal
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
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
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Uncorrected Distance Visual Acuity [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.

  2. Spectacle Independence [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

  1. Vision-related Quality of Life [6 Months After Surgery]

    Vision related quality of life as measured by a subjective subject questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Contact Alcon Call Center for Trial Locations Paris France 75014

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01192321
Other Study ID Numbers:
  • M09-047
First Posted:
Sep 1, 2010
Last Update Posted:
Oct 22, 2012
Last Verified:
Oct 1, 2012
Keywords provided by Alcon Research
intraocular lens
Toric
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Oct 22, 2012