POST-MARKET CLINICAL FOLLOW-UP EVALUATION OF THE TECNIS SYMFONY® plus EXTENDED RANGE OF VISION INTRAOCULAR LENS MODEL ZHR00

Not Applicable

• Conditions: h25; H26; Senile cataract; Other cataract

• Registration Number: DRKS00014919
• Lead Sponsor: Johnson and Johnson Surgical Vision, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-26
• Study Completion: 2019-11-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Age 22 and older
• Bilateral cataracts or crystalline lenses for which posterior chamber IOL implantation has been planned
• Potential postoperative best corrected distance visual acuity (BCDVA) of 0.66 decimal (20/30 Snellen) or better
• Predicted postoperative corneal astigmatism less than 1.0 D
• Clear intraocular media other than cataract in each eye
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Written informed consent for participation in the study and data protection.

Exclusion Criteria

• Requiring an intraocular lens power outside the available range of +14.0 to +26.0 D
• Irregular corneal astigmatism (as evaluated by topography)
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (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 that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 Snellen) 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 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject
• 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 Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
• Known ocular disease or pathology that, in the opinion of the investigator.
• 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 60 days prior to the preoperative visit in any other clinical trial
• Desire for monovision correction

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The postoperative refractive error for each implanted eye will be compared to the planned residual refractive error for that eye. Therefore, the primary study endpoint is that the 95% confidence interval for the residual refraction delta (postoperative refraction spherical equivalent minus the planned residual refraction spherical equivalent) within the ZHR00 lens group will not be significantly different from emmetropia (zero). The key evaluation timepoint for this study will be at the 1-month postoperative visit.