Clinical Investigation of the Next-Generation Intraocular Lens

Abbott

Status: Completed

Conditions: Cataract

Treatments: Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00; Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00; Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00

Study type: Interventional

Funder types: Industry

Identifiers

NCT03111550

EDOF-121-NGPC

Details and patient eligibility

About

This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL.

The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.

Enrollment: 242 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral cataracts
• Potential for postoperative BCDVA of 20/30 Snellen or better
• Corneal astigmatism of 1.00 D or less in both eyes
• Normal corneal topography
• Clear intraocular media other than cataract in each eye
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries

Exclusion criteria

• Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)
• Irregular corneal astigmatism
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
• Inability to achieve keratometric stability for contact lens wearers
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
• Subjects with diagnosed degenerative visual disorders
• Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
• Use of systemic or ocular medications that may affect vision
• Prior, current, or anticipated use of tamsulosin or silodosin
• Poorly-controlled diabetes
• Acute, chronic, or uncontrolled systemic or ocular disease or illness
• Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or may be expected to require retinal laser treatment or other surgical intervention during the course of the study
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
• Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial
• Desire for monovision correction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 3 patient groups

Investigational Lens Device #1

Other group

Description:

Investigational Intraocular Lens Device #1: Tecnis Model ZHR00

Treatment:

Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00

Investigational Lens Device #2

Other group

Description:

Investigational Intraocular Lens Device #2: Tecnis Model ZQR00

Treatment:

Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00

Control Device

Other group

Description:

Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00

Treatment:

Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00