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

Cataracts Clinical Trial

Official title:

Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999492
• Other study ID #: TMF-09-001
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2009
• Last updated: February 26, 2014
• Start date: October 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2014
• Source: Drs. Fine, Hoffman and Packer, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01061892

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• Tecnis® Multifocal (TMF)
Aspheric, diffractive multifocal intraocular lenses

Locations

Country	Name	City	State
United States	Drs. Fine, Hoffman and Packer, LLC	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Mark Packer, MD, FACS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of spectacle wear		3 months postoperatively
Secondary	Frequency and degree of visual symptoms		3 months postoperatively