CataractNCT06567834
Clinical Evaluation and Comparison of the Tecnis Symfony Optiblue and Tecnis Symfony IOLs
A study testing Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150) and Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150) in people with Cataract and Presbyopia, run by Empire Eye and Laser Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150) and Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 9 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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,
- may affect visual acuity
- may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)
- may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
- 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 preoperative visit in any other clinical trial
- Desire for monovision correction
Trial locations and contacts
1 site in 1 country.
United States1 site
Empire Eye and Laser Center
Bakersfield, California, 93309
About this study
Official title: Clinical Evaluation of Violet Light Filtration and High-resolution Lathing on a Diffractive Extended Depth of Focus Intraocular Lens (IOL)
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.
Read the detailed description
This is 6 month, prospective, single center, subject/evaluator masked, bilateral, randomized clinical investigation of the TECNIS Symfony Model ZXR00V/ ZXW150 IOLs versus the TECNIS Symfony Model ZXR00/ZXT150 control IOL.
The study will enroll approximately 60 subjects to achieve approximately 54 randomized and bilaterally implanted subjects, resulting in approximately 25 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZXR00V/ZXW150 or the ZXR00/ ZXT150 control IOL. The eye implanted first will be considered the primary study eye.
Surgeons will perform routine, small-incision cataract surgery and implant the study lenses using an implantation system qualified by the respective manufacturer for use with that IOL. The target for refractive outcomes will be emmetropia for both eyes.
All subjects will undergo a minimum of 7 study visits: Preoperative for both eyes; Operative for each eye; 1 week first eye and second eye, 1 month and 6 month visits for both eyes together.
The primary endpoint is patient reported nighttime dysphotopsia symptoms as measured by the PRVSQ v2 questionnaire.
The secondary endpoints are 25% low contrast visual acuity with glare and patient satisfaction.
OTHER ENDPOINTS
- Monocular photopic uncorrected distance visual acuity (UCDVA)
- Binocular UCDVA and uncorrected near visual acuity (UCNVA) at 40 cm
- 10% and 25% low contrast acuity without glare
- Residual refractive error
- Natural binocular reading distance
- Distance of subjective near blur
- Lens findings/complications
- Spectacle use
- Other ocular/visual symptoms (non-directed chief complaint)
- Patient satisfaction and recommendation
- Time with physician in exam room
- Conditions
- Cataract, Presbyopia
- Being tested
- Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150), Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150)
- Keywords
- Extended Depth of Focus IOLs, Dysphotopsia, Low Contrast Vision, Presbyopia Correction, Halos, Starbursts
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150)Device
Multifocal IOL with violet light filtration and high-resolution lathing
Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150)Device
Multifocal IOL with ultraviolet filtration
| Study group | Role | What they receive |
|---|---|---|
| Tecnis Symfony Optiblue | Experimental | Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (ZXR00V/ZXW150) Receives: Device: Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150) |
| Tecnis Symfony | Active comparator | Tecnis Symfony/Tecnis Symfony Toric (ZXR00/ZXT150) Receives: Device: Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported nighttime dysphotopsia symptoms
Patient-Reported Visual Symptoms Questionnaire (PRVSQ)
Measured: Pre-op visit, 1 month post-op visit, 6 month post-op visit
Secondary outcomes (2)
Low contrast visual acuity with glare
Mesopic 25% low contrast visual acuity with glare
Measured: 1 month post-op visit, 6 month post-op visit
Patient overall satisfaction
Patient Recommendation Questionnaire
Measured: 1 month post-op visit, 6 month post-op visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start21 Mar 2022
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Empire Eye and Laser Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Responsible party
- Principal investigator, Dr. Daniel H. Chang, MD, Empire Eye and Laser Center
- Investigators
- Daniel H Chang, MD, Principal investigator, Empire Eye and Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567834
- Sponsor's protocol ID
- EMP-2022-001
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34269326Hammond 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.
PubMed 31824137Chang 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
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.
PubMed 37071325Zhang 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.
PubMed 34194292van 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.
PubMed 36891506Chang 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.
PubMed 34522079Chang 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.
PubMed 37097283de 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.
PubMed 27943250Han 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.
PubMed 38068421Woodward 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.
PubMed 19465282Ntonti 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.
PubMed 35862830Kim 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.
PubMed 37405796Meikies 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.
PubMed 23811606Hays 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.
PubMed 37055289
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Violet Light Filtration and High-resolution Lathing on a Diffractive Extended Depth of Focus Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT06567834
- Acronym / sponsor ID
- EMP-2022-001
- Conditions
- Cataract, Presbyopia
- Keywords
- Extended Depth of Focus IOLs, Dysphotopsia, Low Contrast Vision, Presbyopia Correction, Halos, Starbursts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Empire Eye and Laser CenterUniversity, hospital or other
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is 6 month, prospective, single center, subject/evaluator masked, bilateral, randomized clinical investigation of the TECNIS Symfony Model ZXR00V/ ZXW150 IOLs versus the TECNIS Symfony Model ZXR00/ZXT150 control IOL.
The study will enroll approximately 60 subjects to achieve approximately 54 randomized and bilaterally implanted subjects, resulting in approximately 25 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZXR00V/ZXW150 or the ZXR00/ ZXT150 control IOL. The eye implanted first will be considered the primary study eye.
Surgeons will perform routine, small-incision cataract surgery and implant the study lenses using an implantation system qualified by the respective manufacturer for use with that IOL. The target for refractive outcomes will be emmetropia for both eyes.
All subjects will undergo a minimum of 7 study visits: Preoperative for both eyes; Operative for each eye; 1 week first eye and second eye, 1 month and 6 month visits for both eyes together.
The primary endpoint is patient reported nighttime dysphotopsia symptoms as measured by the PRVSQ v2 questionnaire.
The secondary endpoints are 25% low contrast visual acuity with glare and patient satisfaction.
OTHER ENDPOINTS
- Monocular photopic uncorrected distance visual acuity (UCDVA)
- Binocular UCDVA and uncorrected near visual acuity (UCNVA) at 40 cm
- 10% and 25% low contrast acuity without glare
- Residual refractive error
- Natural binocular reading distance
- Distance of subjective near blur
- Lens findings/complications
- Spectacle use
- Other ocular/visual symptoms (non-directed chief complaint)
- Patient satisfaction and recommendation
- Time with physician in exam room
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Tecnis Symfony Optiblue | Experimental | Device: Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150)Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (ZXR00V/ZXW150) |
| Tecnis Symfony | Active comparator | Device: Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150)Tecnis Symfony/Tecnis Symfony Toric (ZXR00/ZXT150) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All criteria apply to each study eye
Key exclusion criteria (21 listed)
- All criteria apply to each study eye:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150)Multifocal IOL with violet light filtration and high-resolution lathing | Device | Tecnis Symfony Optiblue |
| Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150)Multifocal IOL with ultraviolet filtration | Device | Tecnis Symfony |
Primary outcome
Patient reported nighttime dysphotopsia symptoms
Time frame: Pre-op visit, 1 month post-op visit, 6 month post-op visit
Patient-Reported Visual Symptoms Questionnaire (PRVSQ)
2 secondary outcomes
Low contrast visual acuity with glare
Time frame: 1 month post-op visit, 6 month post-op visit
Patient overall satisfaction
Time frame: 1 month post-op visit, 6 month post-op visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 34269326Chang 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.
- Background: PubMed 31824137Hammond 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.
- BackgroundChang 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: PubMed 37071325Chang 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.
- Background: PubMed 34194292Zhang 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.
- Background: PubMed 36891506van 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.
- Background: PubMed 34522079Chang 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.
- Background: PubMed 37097283Chang 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.
- Background: PubMed 27943250de 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.
- Background: PubMed 38068421Han 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.
- Background: PubMed 19465282Woodward 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.
- Background: PubMed 35862830Ntonti 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.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel H Chang, MD principal investigator
Empire Eye and Laser Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150) and Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150) in people with Cataract and Presbyopia, run by Empire Eye and Laser Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported nighttime dysphotopsia symptoms (time frame: Pre-op visit, 1 month post-op visit, 6 month post-op visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567834, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.