Clinical Evaluation and Comparison of the Tecnis Symfony Optiblue and Tecnis Symfony IOLs

NCT06567834 | Completed FDA Device

• 1 other identifier: EMP-2022-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to compare the Tecnis Symfony Optiblue intraocular lens implant to the Tecnis Symfony intraocular lens implant in patients over 22 years old with cataracts in both eyes. The main questions it aims to answer are: Which lens has less nighttime side effects? Which lens has higher patient satisfaction? Participants will undergo a minimum of 7 study visits where they will complete a variety of vision tests and vision questionnaires.

Conditions

Cataract; Presbyopia

Keywords

Extended Depth of Focus IOLs; Dysphotopsia; Low Contrast Vision; Presbyopia Correction; Halos; Starbursts

Outcome Measures

Primary Outcomes (1)

• Patient reported nighttime dysphotopsia symptoms

  Patient-Reported Visual Symptoms Questionnaire (PRVSQ)

  Pre-op visit, 1 month post-op visit, 6 month post-op visit

Secondary Outcomes (2)

• Low contrast visual acuity with glare

  1 month post-op visit, 6 month post-op visit

• Patient overall satisfaction

  1 month post-op visit, 6 month post-op visit

Other Outcomes (13)

• Monocular photopic UCDVA

  Pre-op visit

• Monocular photopic UCDVA

  1 week post-op visit first and second eye, 1 month post-op visit, 6 month post-op visit

• Binocular UCDVA

  1 month post-op visit, 6 month post-op visit

Study Arms (2)

Tecnis Symfony Optiblue

EXPERIMENTAL

Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (ZXR00V/ZXW150)

Device: Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150)

Tecnis Symfony

ACTIVE COMPARATOR

Tecnis Symfony/Tecnis Symfony Toric (ZXR00/ZXT150)

Device: Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150)

Interventions

Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150) DEVICE

Multifocal IOL with violet light filtration and high-resolution lathing

Tecnis Symfony Optiblue

Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150) DEVICE

Multifocal IOL with ultraviolet filtration

Tecnis Symfony

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 each study eye
• Minimum 22 years of age
• Bilateral cataracts for which posterior chamber IOL implantation has been planned
• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with a glare source or 20/40 Snellen or worse without a glare source
• Potential for postoperative BCDVA of 20/30 Snellen or better
• Corneal astigmatism:
• Normal corneal topography
• Preoperative corneal astigmatism range from 0 D - 2.0 D
• Clear intraocular media other than cataract in each eye
• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
• Ability to understand and respond to a questionnaire in English

You may not qualify if:

• All criteria apply to each study eye:
• Requiring an intraocular lens power outside the available range of power
• 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 surgery (LASIK, LASEK, radial keratotomy (RK), photorefractive keratectomy (PRK), etc.) or intraocular surgery. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcomes or increase risk to the subject, are acceptable.
• 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
• Subject 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 (e.g., Flomax, Flomaxtra, Rapaflo) 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
• 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, 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

• Empire Eye and Laser Center: lead
• Johnson & Johnson Surgical Vision, Inc.: collaborator

Study Sites (1)

Empire Eye and Laser Center

Bakersfield, California, 93309, United States

Location

Related Publications (18)

• Chang DH, Janakiraman DP, Smith PJ, Buteyn A, Domingo J, Jones JJ, Christie WC. Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. J Cataract Refract Surg. 2022 Mar 1;48(3):288-297. doi: 10.1097/j.jcrs.0000000000000747.

  PMID: 34269326 BACKGROUND

• Hammond BR, Sreenivasan V, Suryakumar R. The Effects of Blue Light-Filtering Intraocular Lenses on the Protection and Function of the Visual System. Clin Ophthalmol. 2019 Dec 5;13:2427-2438. doi: 10.2147/OPTH.S213280. eCollection 2019.

  PMID: 31824137 BACKGROUND

• Chang DH, Pastuck T, Rosen R, Hollmann S, Babic T, Stapars A. Violet and Blue Light: Impact of High-Energy Light on Vision and Health. (2020) Violet and Blue Light: Impact of High-Energy Light on Vision and Health. J Ophthalmic Stud 3(2):1-8. dx.doi.org/10.16966/2639-152X.119

  BACKGROUND

• Chang DH, Thompson VM, Christie WC, Chu YR, Vida RS. Clinical Evaluation of a Modified Light Transmission Short-Wavelength Filtering Intraocular Lens Compared to a Colorless Control. Ophthalmol Ther. 2023 Jun;12(3):1775-1785. doi: 10.1007/s40123-023-00709-w. Epub 2023 Apr 18.

  PMID: 37071325 BACKGROUND

• Zhang L, Lin D, Wang Y, Chen W, Xiao W, Xiang Y, Zhu Y, Chen C, Dong X, Liu Y, Chen W, Lin H. Comparison of Visual Neuroadaptations After Multifocal and Monofocal Intraocular Lens Implantation. Front Neurosci. 2021 Jun 14;15:648863. doi: 10.3389/fnins.2021.648863. eCollection 2021.

  PMID: 34194292 BACKGROUND

• van der Mooren M, Alarcon A, Jenkins Sanchez MD, Chang DH. Effect of Violet Light-Filtering and Manufacturing Improvements in an Extended Depth-of-Focus Intraocular Lens on Visual Performance. Clin Ophthalmol. 2023 Mar 1;17:701-709. doi: 10.2147/OPTH.S396823. eCollection 2023.

  PMID: 36891506 BACKGROUND

• Chang DH, Waring GO, Hom M, Barnett M. Presbyopia Treatments by Mechanism of Action: A New Classification System Based on a Review of the Literature. Clin Ophthalmol. 2021 Sep 6;15:3733-3745. doi: 10.2147/OPTH.S318065. eCollection 2021.

  PMID: 34522079 BACKGROUND

• Chang DH, Hu JG, Lehmann RP, Thompson VM, Tsai LH, Thomas EK. Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial. J Cataract Refract Surg. 2023 Aug 1;49(8):840-847. doi: 10.1097/j.jcrs.0000000000001205.

  PMID: 37097283 BACKGROUND

• de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.

  PMID: 27943250 BACKGROUND

• Han KE, Lee JE. Comparative Evaluation of Visual Performance and Patient Satisfaction following Cataract Surgery: A Retrospective Analysis of an Extended Depth-of-Focus Intraocular Lens and a Diffractive Multifocal Lens with Extended Depth of Focus. J Clin Med. 2023 Nov 28;12(23):7368. doi: 10.3390/jcm12237368.

  PMID: 38068421 BACKGROUND

• Woodward MA, Randleman JB, Stulting RD. Dissatisfaction after multifocal intraocular lens implantation. J Cataract Refract Surg. 2009 Jun;35(6):992-7. doi: 10.1016/j.jcrs.2009.01.031.

  PMID: 19465282 BACKGROUND

• Ntonti P, Bakirtzis M, Delibasis K, Seimenis I, Tsinopoulos I, Labiris G. Impact of personality on the decision process and on satisfaction rates in pseudophakic presbyopic correction. J Cataract Refract Surg. 2022 Dec 1;48(12):1433-1439. doi: 10.1097/j.jcrs.0000000000001021.

  PMID: 35862830 BACKGROUND

• Kim EC, Cho SY, Kang JE, Nam G, Yoon YC, Whang WJ, Na KS, Kim HS, Hwang HS. Comparative Analysis of Optical Quality of Monofocal, Enhanced Monofocal, Multifocal, and Extended Depth of Focus Intraocular Lenses: A Mobile Model Eye Study. Transl Vis Sci Technol. 2023 Jul 3;12(7):5. doi: 10.1167/tvst.12.7.5.

  PMID: 37405796 BACKGROUND

• Meikies D, van der Mooren M, Terwee T, Guthoff RF, Stachs O. Rostock Glare Perimeter: a distinctive method for quantification of glare. Optom Vis Sci. 2013 Oct;90(10):1143-8. doi: 10.1097/OPX.0b013e318295a720.

  PMID: 23811606 BACKGROUND

• Hays RD, MacRae S, Holladay J, Tarver ME, Lum F, Stark W, Weidmer B, Kumar N, Lau G, Nguyen T, Schallhorn S, Eydelman M, Masket S. Development of a Patient-Reported Outcome Measure to Assess Symptoms Associated with Cataract Surgery and Intraocular Lens Implants. Ophthalmology. 2023 Jul;130(7):715-725. doi: 10.1016/j.ophtha.2023.02.026. Epub 2023 Apr 12.

  PMID: 37055289 BACKGROUND

• Masket S, Lum F, MacRae S, Hays RD, Tarver ME, Holladay J, Yoon G, Nguyen T, Stark W, Kumar N, Lau G, Schallhorn S, Eydelman M. Symptoms and Satisfaction Levels Associated with Intraocular Lens Implants in the Monofocal and Premium IOL Patient-Reported Outcome Measure Study. Ophthalmology. 2023 Jul;130(7):726-734. doi: 10.1016/j.ophtha.2023.02.027. Epub 2023 Apr 15.

  PMID: 37061911 BACKGROUND

• Aslam TM, Dhillon B, Tallentire VR, Patton N, Aspinal P. Development of a forced choice photographic questionnaire for photic phenomena and its testing - repeatability, reliability and validity. Ophthalmologica. 2004 Nov-Dec;218(6):402-10. doi: 10.1159/000080944.

  PMID: 15564759 BACKGROUND

• Chang DH, Kao AA, Huggins LK, Albert JN, Whinery JN, Camirand BM. Clinical Evaluation of Violet Light Filtration and High-Resolution Lathing on a Diffractive Extended Depth of Focus IOL. Ophthalmol Ther. 2024 Dec;13(12):3135-3147. doi: 10.1007/s40123-024-01056-0. Epub 2024 Oct 25.

  PMID: 39455493 DERIVED

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Daniel H Chang, MD

  Empire Eye and Laser Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible subjects were randomly assigned 1:1 to bilateral implantation with either Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (ZXR00V/ZXW150) or Tecnis Symfony/Tecnis Symfony Toric (ZXR00/ZXT150).

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: March 21, 2022
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)