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

Primary Purpose

Cataract

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Toric T3 - T9
Monofocal
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring intraocular lens, Toric

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Toric T3 - T9

Monofocal

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
August 30, 2010
Last Updated
October 19, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01192321
Brief Title
Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation
Official Title
Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Business decision to close study based on low enrollment
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
intraocular lens, Toric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toric T3 - T9
Arm Type
Experimental
Arm Description
Bilateral implantation of a Toric intraocular lens (IOL) models T3, T4, T5, T6, T7, T8 or T9
Arm Title
Monofocal
Arm Type
Active Comparator
Arm Description
Bilateral implantation of a monofocal intraocular lens (IOL) model with no toric component.
Intervention Type
Device
Intervention Name(s)
Toric T3 - T9
Intervention Description
Bilateral implantation of Alcon AcrySof Toric Intraocular Lens (IOL) models SN60T3 through SN60T9 following cataract removal.
Intervention Type
Device
Intervention Name(s)
Monofocal
Intervention Description
Bilateral implantation of any monofocal Intraocular Lens (IOL) following cataract removal.
Primary Outcome Measure Information:
Title
Uncorrected Distance Visual Acuity
Description
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.
Time Frame
6 Months After Surgery
Title
Spectacle Independence
Description
Spectacle Independence (the ability of the patient to go without corrective lenses) measured by a subjective patient questionnaire.
Time Frame
6 Months After Surgery
Secondary Outcome Measure Information:
Title
Vision-related Quality of Life
Description
Vision related quality of life as measured by a subjective subject questionnaire.
Time Frame
6 Months After Surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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

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