Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tecnis Multifocal IOL
crystalens Accommodating IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL
- Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
- Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
- Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
- Use of systemic or ocular medications that may affect visual outcomes
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
- History of ocular trauma
- History of ocular surgery other than that required for inclusion in this study
- Amblyopia or strabismus
- Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
Sites / Locations
- Drs. Fine, Hoffman and Packer, LLC
Outcomes
Primary Outcome Measures
Visual function
Secondary Outcome Measures
Use of spectacle correction and vision-related quality of life
Full Information
NCT ID
NCT01275118
First Posted
January 10, 2011
Last Updated
February 26, 2014
Sponsor
Mark Packer, MD, FACS
Collaborators
Abbott Medical Optics
1. Study Identification
Unique Protocol Identification Number
NCT01275118
Brief Title
Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL
Official Title
Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence With Bilateral Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens AO (CAO) Intraocular Lens
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Packer, MD, FACS
Collaborators
Abbott Medical Optics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Tecnis Multifocal IOL
Intervention Description
Presbyopia correcting IOL
Intervention Type
Device
Intervention Name(s)
crystalens Accommodating IOL
Intervention Description
Presbyopia correcting IOL
Primary Outcome Measure Information:
Title
Visual function
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Use of spectacle correction and vision-related quality of life
Time Frame
3 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL
Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
Use of systemic or ocular medications that may affect visual outcomes
Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
Uncontrolled systemic or ocular disease
History of ocular trauma
History of ocular surgery other than that required for inclusion in this study
Amblyopia or strabismus
Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
Subjects who may be expected to require retinal laser treatment or other surgical intervention
Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Packer, MD, FACS, CPI
Organizational Affiliation
Drs. Fine, Hoffman and Packer, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drs. Fine, Hoffman and Packer, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL
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