CataractNCT05025345
Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses
A study testing Tecnis Eyhance and Tecnis 1 piece IOL in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 15 sites in United States.
Trial summary
This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Tecnis Eyhance and Tecnis 1 piece IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 15 sitesUnited States
- Study dates
- 2 Sep 2021to 17 Jun 2022
- 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
- No healthy volunteers
- 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
- Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
- Potential for postoperative best corrected visual acuity of 20/30 Snellen or better
- Corneal astigmatism parameters:
- Normal corneal topography and no irregular corneal astigmatism
Show all 11Show fewer
- Postoperative astigmatism can be surgically managed to be less than 1 D in each eye
- Clear intraocular media other than cataract in each eye
- Availability, willingness, ability, 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
- Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
- Desire for monovision correction
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, 21401
Empire Eye & Laser Center
Bakersfield, California, 93309
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16606
Key-Whitman Eye Center
Dallas, Texas, 75243
Berkeley Eye Institute, P.A.
Houston, Texas, 77027
Whitsett Vision Group
Houston, Texas, 77055
Texas Eye and Laser Center
Hurst, Texas, 76054
Eye Care Specialists
Kingston, Pennsylvania, 18704
Southern California Eye Physicians and Associates
Long Beach, California, 90805
Focal Point Vision
San Antonio, Texas, 78209
Parkhurst NuVision
San Antonio, Texas, 78229
R & R Eye Research, LLC
San Antonio, Texas, 78229
Center For Sight
Sarasota, Florida, 34239
Jones Eye Clinic
Sioux City, Iowa, 51104
Tekwani Vision Center
St Louis, Missouri, 63128
About this study
Official title: Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses
This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL.
The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.
- Conditions
- Cataract
- Being tested
- Tecnis Eyhance, Tecnis 1 piece IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis EyhanceDevice
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Tecnis 1 piece IOLDevice
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
| Study group | Role | What they receive |
|---|---|---|
| Study Lens | Experimental | Tecnis Eyhance Receives: Device: Tecnis Eyhance |
| Control Lens | Active comparator | Tecnis 1 piece IOL (Intraocular lens) Receives: Device: Tecnis 1 piece IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups
Measured: 6 months
Secondary outcomes (1)
MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)
the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start2 Sep 2021
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
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
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Surgical Vision Clinical Trials, Study director, Johnson & Johnson Surgical Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025345
- Sponsor's protocol ID
- EMON-101-EHCE
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2021
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses
- ClinicalTrials.gov ID
- NCT05025345
- Acronym / sponsor ID
- EMON-101-EHCE
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Posted 28 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL.
The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Lens | Experimental | Device: Tecnis EyhanceTecnis Eyhance |
| Control Lens | Active comparator | Device: Tecnis 1 piece IOLTecnis 1 piece IOL (Intraocular lens) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 or without a glare source
- Potential for postoperative best corrected visual acuity of 20/30 Snellen or better
- Corneal astigmatism parameters:
Key exclusion criteria (4 listed)
- Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
- Desire for monovision correction
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 EyhanceInvestigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes. | Device | Study Lens |
| Tecnis 1 piece IOLControl intraocular lens replaces the natural lens removed during cataract surgery in both eyes. | Device | Control Lens |
Primary outcome
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
Time frame: 6 months
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups
1 secondary outcome
MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
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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.
Johnson & Johnson Surgical Vision Clinical Trials study director
Johnson & Johnson Surgical Vision
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecnis Eyhance and Tecnis 1 piece IOL in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 15 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 11 inclusion and 4 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 28 Aug 2023). 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 BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA) (time frame: 6 months). 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 28 Aug 2023.