CataractNCT03500198
Clinical Investigation of the Next Generation Intraocular Lens
A study testing Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 10 sites in United States.
Trial summary
An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 10 sitesUnited States
- Study dates
- 28 Jun 2018to 5 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum 22 years of age
- Bilateral cataracts for which posterior chamber IOL implantation has been planned
- Corneal astigmatism:
- Normal corneal topography
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits
- 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
- Irregular corneal astigmatism
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
- Poorly-controlled diabetes
- 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
The Eye Associates of Manatee, LLP
Bradenton, Florida, 34209
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Key-Whitman Eye Center
Dallas, Texas, 11442
Berkeley Eye Institute, P.A.
Houston, Texas, 77027
Slade & Baker Vision
Houston, Texas, 77027
Levenson Eye Associates, Inc.
Jacksonville, Florida, 32204
Eye Care Specialists
Kingston, Pennsylvania, 18704
Jones Eye Clinic
Sioux City, Iowa, 51104
Vance Thompson Vision Clinic, Prof LLC
Sioux Falls, South Dakota, 57108
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
Official title: Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.
Read the detailed description
The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.
- Conditions
- Cataract
- Being tested
- Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL, Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Intraocular Lens Device #1: Next Generation TECNIS IOLDevice
Intraocular lens replaces the natural lens removed during cataract surgery.
Control Monofocal Intraocular Lens: TECNIS Monofocal IOLDevice
Intraocular lens replaces the natural lens removed during cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device: Next Generation TECNIS IOL | Experimental | Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL Receives: Device: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL |
| Control Device: TECNIS Monofocal IOL | Active comparator | Control Monofocal Intraocular Lens: TECNIS Monofocal IOL Receives: Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Measured: 6 months (postoperative)
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.
Measured: 6 months (postoperative)
Secondary outcomes (2)
Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only.
Measured: 6 months (postoperative)
Overall Spectacle Wear
Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time".
Measured: 6 months (postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start28 Jun 2018
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Devi Priya Janakiraman, OD, FAAO, Study director, Johnson & Johnson Surgical Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500198
- Sponsor's protocol ID
- SUR-IOL-652-2001
- Status last verified
- Jun 2020
- First submitted
- 9 Apr 2018
- Last updated
- 25 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
- ClinicalTrials.gov ID
- NCT03500198
- Acronym / sponsor ID
- SUR-IOL-652-2001
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 25 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.
Detailed description
The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Device: Next Generation TECNIS IOL | Experimental | Device: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOLInvestigational Intraocular Lens Device #1: Next Generation TECNIS IOL |
| Control Device: TECNIS Monofocal IOL | Active comparator | Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOLControl Monofocal Intraocular Lens: TECNIS Monofocal IOL |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum 22 years of age
- Bilateral cataracts for which posterior chamber IOL implantation has been planned
- Corneal astigmatism:
- Normal corneal topography
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits
Key exclusion criteria (7 listed)
- Irregular corneal astigmatism
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
- Poorly-controlled diabetes
- 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
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 |
|---|---|---|
| Investigational Intraocular Lens Device #1: Next Generation TECNIS IOLIntraocular lens replaces the natural lens removed during cataract surgery. | Device | Investigational Device: Next Generation TECNIS IOL |
| Control Monofocal Intraocular Lens: TECNIS Monofocal IOLIntraocular lens replaces the natural lens removed during cataract surgery. | Device | Control Device: TECNIS Monofocal IOL |
Primary outcome
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
Time frame: 6 months (postoperative)
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Time frame: 6 months (postoperative)
Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.
2 secondary outcomes
Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Time frame: 6 months (postoperative)
Overall Spectacle Wear
Time frame: 6 months (postoperative)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Devi Priya Janakiraman, OD, FAAO study director
Johnson & Johnson Surgical Vision, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 10 sites 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 7 inclusion and 7 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 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Yes. Results are posted in the registry (first posted 25 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) (time frame: 6 months (postoperative)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2020.