Clinical Investigation of a New Intraocular Lens

Abbott

Status: Completed

Conditions: Cataract

Treatments: Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00; Device: TECNIS Monofocal IOL, Model ZCB00

Study type: Interventional

Funder types: Industry

Identifiers

NCT02203721

EROV-106-ZXRC

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.

Enrollment: 324 patients

Sex: All

Ages: 22 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum 22 years of age
• Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
• Potential for postoperative BCDVA of 20/30 Snellen or better
• Corneal astigmatism
• Clear intraocular media, other than cataract
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent and HIPAA authorization
• Ability to understand and respond to a questionnaire in English or Spanish

Exclusion criteria

• Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D
• Pupil abnormalities
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
• Prior corneal refractive or intraocular surgery
• Corneal abnormalities
• Inability to achieve keratometric stability for contact lens wearers
• Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse during the study
• 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 during the course of the 6-month study of tamsulosin or silodosin, that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject
• Inability to focus or fixate for prolonged periods of time
• Poorly-controlled diabetes
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study.
• 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 30 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: Triple Blind

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324 participants in 2 patient groups

TECNIS Symfony Extended Range of Vision IOL, Model ZXR00

Experimental group

Description:

Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00

Treatment:

Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00

TECNIS Monofocal IOL, Model ZCB00

Active Comparator group

Description:

Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00

Treatment:

Device: TECNIS Monofocal IOL, Model ZCB00