Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

Cataract Clinical Trial

Official title:

Clinical Evaluation of the Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747565
• Other study ID #: DIOL-104-TCNS & DIOL-101-TCNS
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: February 27, 2013
• Start date: November 2004
• Est. completion date: November 2008

Study information

• Verified date: February 2013
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.

Description:

The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: November 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Visual potential of 20/30 or better in each study eye

• Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)

• Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye

• Preoperative corneal astigmatism of 1.0 D or less

Exclusion Criteria:

• Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)

• Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)

• Uncontrolled systemic or ocular disease

• History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention

• Presence of ocular pathology other than cataract such as:

• Amblyopia or strabismus

• Corneal abnormalities

• Pupil abnormalities

• Capsule or zonule abnormalities

• Intraocular inflammation

• Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)

• Requiring an intraocular lens outside the study diopter range

• Contact lens usage prior to study procedure (time interval dependent upon contact lens type)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Tecnis ZM900 Multifocal Intraocular Lens
Investigational intraocular lens
• CeeOn 911A monofocal IOL
Monofocal Control IOL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.	Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.	One year	Yes
Primary	Mean Binocular Distance Corrected Near Visual Acuity in Snellen	Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.	One year	No