Depth of FocusSierraNCT06767319

Prospective, Multi-center, Non-interventional, Open Label, Randomized (Depth of Focus Testing Sequences), Clinical Study

An observational study of Depth of Focus, run by Johnson & Johnson Surgical Vision, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this clinical study is to evaluate the difference in depth of focus measured with two methods in patients implanted with either TECNIS 1-piece Monofocal IOL or TECNIS Eyhance IOL: 1. Trial lens method 2. Chart testing at appropriate focal distances (or viewing distances) Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Depth of Focus
How many people: 79 participants
Where: 4 sitesUnited States
Study dates: 18 Dec 2024to 11 Mar 2025
Phase: Observational
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
Healthy volunteers accepted
Adult, Older adult

Study population: As only one eye per subject will be enrolled in the study based on the eligibility criteria, up to 115 subjects will be enrolled to obtain data on approximately 80 subjects to account for approximately 30% screen failure rate.

Study Eye Inclusion Criteria:

Patients unilaterally or bilaterally implanted with a TECNIS non-toric/toric monofocal or TECNIS non-toric/toric Eyhance IOL;
Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws in U.S.;
Availability, willingness, and sufficient cognitive awareness to comply with examination procedures.
Adults (Minimum 22 years of age or older at the time of participation in the study);

Study Eye Exclusion Criteria

Patients within 30 days postoperative from surgery;
BCDVA worse than 20/32;
Posterior capsular opacification or other medical findings affecting best-corrected distance visual acuity (BCDVA) in the opinion of the investigator;
Clinically significant ocular surface disease that would affect study measurements based on investigator medical opinion;
Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
Known ocular disease or pathology that, in the opinion of the investigator may affect visual acuity (macular degeneration, cystoid macular edema, diabetic retinopathy, glaucoma, retinal detachment etc.);
Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Empire Eye & Laser Center
Bakersfield, California, 93309
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Parkhurst NuVision
San Antonio, Texas, 78229
Jones Eye Center
Sioux City, Iowa, 51104

Other trials in United States

About this study

Official title: Comparison of Depth of Focus Testing Methods

The purpose of this clinical study is to evaluate the difference in depth of focus measured with two methods in patients implanted with either TECNIS 1-piece Monofocal IOL or TECNIS Eyhance IOL:

Trial lens method
Chart testing at appropriate focal distances (or viewing distances)

Conditions: Depth of Focus
Being tested: No intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.

Study groups in NCT06767319
Study group	Role	What they receive
Testing Order		The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group. Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
Measured: One day Visit study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 202411 Mar 2025

First posted9 Jan 2025
Study start18 Dec 2024
Primary completion11 Mar 2025
Study completion11 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depth of FocusStudies 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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06767319
Sponsor's protocol ID: MDEV110SDVA
Acronym: Sierra
Status last verified: Jan 2026
First submitted: 17 Dec 2024
Last updated: 16 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
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Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
Not yet recruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Not yet recruitingPhase 4
Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match
Presbyopia Correction, Presbyopia
Active, not recruiting
Intervention to Improve Utilization of Extended Venous Thromboembolism Prophylaxis After Cancer Surgery
Venous Thromboembolism, Pulmonary Embolism

All Depth of Focus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Depth of Focus Testing Methods
ClinicalTrials.gov ID: NCT06767319
Acronym / sponsor ID: Sierra / MDEV110SDVA
Conditions: Depth of Focus
Study type: Observational
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
Study start: 18 Dec 2024 (actual)
Primary completion: 11 Mar 2025 (actual)
Study completion: 11 Mar 2025 (actual)
First posted: 9 Jan 2025 (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 purpose of this clinical study is to evaluate the difference in depth of focus measured with two methods in patients implanted with either TECNIS 1-piece Monofocal IOL or TECNIS Eyhance IOL:

Trial lens method
Chart testing at appropriate focal distances (or viewing distances)

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Testing Order	–	Other: No interventionThe difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: As only one eye per subject will be enrolled in the study based on the eligibility criteria, up to 115 subjects will be enrolled to obtain data on approximately 80 subjects to account for approximately 30% screen failure rate.

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
No interventionThe difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.	Other	Testing Order

Primary outcome

The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
Time frame: One day Visit study
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.

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 16 Jan 2026.
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

Related trials for Depth of Focus

Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
Not yet recruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Not yet recruitingPhase 4
Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match
Presbyopia Correction, Presbyopia
Active, not recruiting
Intervention to Improve Utilization of Extended Venous Thromboembolism Prophylaxis After Cancer Surgery
Venous Thromboembolism, Pulmonary Embolism

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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Depth of Focus, run by Johnson & Johnson Surgical Vision, Inc. at 4 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?

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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

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?

The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group. (time frame: One day Visit study). 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 NCT06767319.

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 16 Jan 2026.