Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275118
• Other study ID #: TMF-09-002 Rev.5
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2011
• Last updated: February 26, 2014
• Start date: December 2010
• Est. completion date: September 2011

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

Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Tecnis Multifocal IOL
Presbyopia correcting IOL
• crystalens Accommodating IOL
Presbyopia correcting IOL

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Mark Packer, MD, FACS	Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual function		3 months postoperatively
Secondary	Use of spectacle correction and vision-related quality of life		3 months postoperatively