Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

Aphakia Clinical Trial

Official title:

Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061281
• Other study ID #: Tecnis MF/Crystalens
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2010
• Last updated: January 13, 2012
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or greater

• Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes

• Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation

• Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen

• Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes

• Preoperative corneal astigmatism of 1.0 D or less

• Clear intraocular media other than cataract

• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• Use of systemic or ocular medications that may affect vision

• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)

• Subjects with diabetes mellitus

• 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 20/30 or worse

• 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, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)

• Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses

• Requiring an intraocular lens < 15.0 or > 26.0 diopters

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• Tecnis MF IOL
20 patients enrolled with the Tecnis MF IOL.
• Crystalens AO IOL
20 patients enrolled with the Crystalens AO

Locations

Country	Name	City	State
United States	Farrell Tyson	Cape Coral	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refraction		1 year	No
Primary	Distance Visual Acuities		1 year	No