Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mark Packer, MD, FACS, Drs. Fine, Hoffman and Packer, LLC

ClinicalTrials.gov Identifier:

NCT00999492

First received: October 19, 2009

Last updated: February 16, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 19, 2009
Last Updated Date	February 16, 2012
Start Date ^ICMJE	October 2009
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 20, 2009)	Frequency of spectacle wear [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00999492 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 20, 2009)	Frequency and degree of visual symptoms [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront
Official Title ^ICMJE	Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront
Brief Summary	Given the availability of aspheric diffractive IOLs with varying negative spherical aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and thereby maximize visual performance.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cataracts
Intervention ^ICMJE	Device: Tecnis® Multifocal (TMF) Aspheric, diffractive multifocal intraocular lenses
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	8
Completion Date	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 18 years of age or older Scheduled to undergo bilateral cataract or refractive lens surgery Visual potential of 20/30 or better in each eye after lens removal and IOL implantation Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes Preoperative regular corneal astigmatism of 2.5 D or less Clear intraocular media other than cataract Availability, willingness, and sufficient cognitive awareness to comply with examination procedures Exclusion Criteria: Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance. Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D) 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 or prior ocular surgery 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) Contact lens usage within 6 months for PMMA lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses Requiring an intraocular lens power <15.0 or >26.0 diopters
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00999492
Other Study ID Numbers ^ICMJE	TMF-09-001
Has Data Monitoring Committee	No
Responsible Party	Mark Packer, MD, FACS, Drs. Fine, Hoffman and Packer, LLC
Study Sponsor ^ICMJE	Mark Packer, MD, FACS
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Drs. Fine, Hoffman and Packer, LLC
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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