A Comparative Study of TECNIS Symfony Plus IOL and a Trifocal IOL

NCT04156737 | Completed

• 1 other identifier: SUR-IOL-652-3002
• Study Type: interventional
• Target: 205
• Locations: 3 countries
• Sites: 5

Brief Summary

This is a multicenter, prospective, randomized, subject- and evaluator-masked, bilateral-implant study conducted at up to 15 sites worldwide. A total of up to 280 subjects will be randomized in a 1:1 ratio for implantation with either the TECNIS Symfony plus IOL Model ZHR00V or the Trifocal IOL. This will ensure that data from at least 100 subjects in the TECNIS Symfony plus lens group and at least 100 subjects in the Trifocal lens group will be available for analysis at the 6-month follow-up timepoint. All subjects will be followed for up to 6 months postoperative.

Conditions

Cataract; Refractive Error

Outcome Measures

Primary Outcomes (2)

• Binocular distance-corrected VA of 20/25

  Percent of subjects who achieve binocular distance-corrected VA of 20/25 (6.7.5) Snellen or better at far, intermediate, and near (40 cm)

  3 months

• Binocular uncorrected VA of 20/32

  Percent of subjects who achieve binocular uncorrected VA of 20/32 or better at far and near (40 cm)

  3 months

Study Arms (2)

Investigational Lens

EXPERIMENTAL

TECNIS Symfony plus IOL Model ZHR00V

Device: TECNIS Symfony plus IOL Model ZHR00V

Control Lens

ACTIVE COMPARATOR

Trifocal Intraocular Lens

Device: Trifocal Intraocular lens

Interventions

TECNIS Symfony plus IOL Model ZHR00V DEVICE

IOL replaces the natural lens removed during cataract surgery

Investigational Lens

Trifocal Intraocular lens DEVICE

IOL replaces the natural lens removed during cataract surgery

Control Lens

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (all criteria apply to both eyes):
• Age 22 and older
• Bilateral cataracts or clear 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 or 6/9 Snellen) or better
• Predicted postoperative corneal astigmatism less than 1.0 D, including posterior corneal astigmatism (PCA)
• Clear intraocular media other than cataract in each eye
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
• Written informed consent for participation in the study and data protection.

You may not qualify if:

• (including device labeling, all criteria apply to both eyes):
• Require 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 (e.g., any observed guttata) that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 or 6/9 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
• Pupil abnormalities that may affect visual outcomes or increase risk to the subject
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 or 6/9 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, in the opinion of the investigator, may affect vision
• Prior, current, or anticipated use during 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 (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
• Poorly-controlled diabetes or hypertension that, in the opinion of the investigator, may mpact visual outcome or increase the risk to the subject
• 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 (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). 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,

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (5)

Auckland Eye Institute

Remuera, Auckland, 1050, New Zealand

Location

Asian Eye Institute

Makati, 1200, Philippines

Location

Clinica de Oftalmologia de Cordoba

Córdoba, Spain

Location

Centro Ocular de Alta Technologia Oftalmos

Madrid, Spain

Location

Miranza IOL Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

Cataract; Refractive Errors

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Unmasked study personnel at the site will be trained to the randomization process through the EDC system and will randomize subjects. The surgeon and the operative staff will know which lens type is implanted. There may also be site coordinators and other site study staff, such as those performing slit-lamp exams, who will be unmasked. Unmasked study site staff will be instructed not to disclose the lens type the subject received or to talk about the lens to any masked evaluators or to the study subjects. The subjects and the study technicians performing the postoperative vision tests are to be masked through study completion. To maintain subject masking, a temporary IOL implant identification card will be issued to the subject at the time of surgery. Following completion of the final study exam, each subject will be given the permanent IOL implant identification card.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 7, 2019
• Study Start: January 24, 2020
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1); PH (1); ES (3)