Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match

September 30, 2026 updated by: Dr. Daniel H. Chang, MD

The purpose of the study is to evaluate the binocular clinical endpoints of distance, intermediate, and near vision and patient reported outcomes utilizing mini-monovision versus mix-match approaches for the correction of presbyopia with intraocular lenses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Presbyopia, defined as the age-related loss of accommodative amplitude, affects essentially all human beings beyond the age of 45 and impacts the ability of the eye to focus at near distances. Current intraocular lens (IOL) options for cataract patients who desire improved vision across a range of distances include full depth of field (DOFi) IOLs and extended depth of field (EDOF) IOLs. Patients implanted with full depth of field IOLs may sometimes experience dysphotopsias (e.g., glare and halos), particularly at night.

The goal with the correction of presbyopia is to maximize near visual range while minimizing the dysphotopsia profile. Bilateral implantation of extended depth of field lenses with a mini-monovision aim is one way to achieve this goal. EDOF lenses minimize the dysphotopsia profile and a near aim in the non-dominant eye will maximize the near visual range. Another option to achieve this goal is the mix-match approach with EDOF and a DOFi lens. The EDOF IOL minimizes the dysphotopsia profile while DOFi IOL maximizes the near visual range.

The hypothesis is that the mini-monovision and mix-match group will have equivalent uncorrected intermediate visual acuities. The mini-monovision group will have superior visual symptoms and the mix-match group will have superior uncorrected distance and near visual acuity, and spectacle independence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Empire Eye and Laser Center
        • Principal Investigator:
          • Daniel H Chang, MD
        • Sub-Investigator:
          • Andrew A Kao, MD
        • Sub-Investigator:
          • Laura K Huggins, OD
        • Sub-Investigator:
          • Jacqueline N Albert, OD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Expected post-operative astigmatism < 1.0 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

Exclusion Criteria:

  • 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 (SMILE, LASIK, LASEK, RK, 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 soft contact lens wearers
  • History of PMMA or RGP contact lens wear within the last 5 years
  • 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 3 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mini-Monovision (TECNIS PureSee)

Participants will receive bilateral TECNIS PureSee IOLs (Model DEN00V/DET150), with the non-dominant eye targeted for a "second minus" near aim to achieve mini-monovision.
Device: TECNIS PureSee IOL (Model DEN00V/DET150)

Bilateral implantation of the TECNIS PureSee intraocular lens following standard phacoemulsification cataract surgery. The non-dominant eye is intentionally targeted for a "second minus" near focus strategy (mini-monovision).

Device: TECNIS PureSee IOL (Model DEN00V/DET150)

Implantation of the TECNIS PureSee intraocular lens into the dominant eye following standard phacoemulsification cataract surgery.
Experimental: Mix-Match (TECNIS PureSee + TECNIS Odyssey)

Participants will receive a TECNIS PureSee IOL (Model DEN00V/DET150) in their dominant eye and a TECNIS Odyssey IOL (Model DRN00V/DRT150) in their non-dominant eye.
Device: TECNIS PureSee IOL (Model DEN00V/DET150)

Bilateral implantation of the TECNIS PureSee intraocular lens following standard phacoemulsification cataract surgery. The non-dominant eye is intentionally targeted for a "second minus" near focus strategy (mini-monovision).

Device: TECNIS PureSee IOL (Model DEN00V/DET150)

Implantation of the TECNIS PureSee intraocular lens into the dominant eye following standard phacoemulsification cataract surgery.

Device: TECNIS Odyssey IOL (Model DRN00V/DRT150)

Implantation of the TECNIS Odyssey intraocular lens into the non-dominant eye following standard phacoemulsification cataract surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Binocular UCDVA
Time Frame: At 3-month postoperative study visit

Binocular Uncorrected Distance Visual Acuity
At 3-month postoperative study visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Binocular UCIVA
Time Frame: At 3-month postoperative study visit

Binocular Uncorrected Intermediate Visual Acuity
At 3-month postoperative study visit
Binocular UCNVA
Time Frame: At 3-month postoperative study visit

Binocular Uncorrected Near Visual Acuity
At 3-month postoperative study visit
Patient Reported Outcomes PRVSQv2
Time Frame: At 3-month postoperative study visit

Patient Reported Outcomes (as recorded by the PRVSQ2 questionnaire). The questionnaire does not generate a scale-based or indexed score. Results are analyzed descriptively, capturing the frequency and distribution of specific visual complaints reported across the study population.
At 3-month postoperative study visit
Patient Reported Outcomes PRSIQv2
Time Frame: At 3-month postoperative study visit.

Patient Reported Outcomes (as recorded by the PRSIQ2 questionnaire). The questionnaire does not generate a scale-based or indexed score. Results are analyzed descriptively, capturing the frequency and distribution of specific visual complaints reported across the study population.
At 3-month postoperative study visit.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Residual Refractive Error
Time Frame: At 3-month postoperative study visit

Residual Refractive Error
At 3-month postoperative study visit
Halometry
Time Frame: At 3-month postoperative study visit

Dysphotopsias Measured by Clinical Halometry
At 3-month postoperative study visit
Spectacle Use
Time Frame: At 3-month postoperative study visit

Patient Reported Spectacle Use
At 3-month postoperative study visit
Other Ocular/Visual Symptoms
Time Frame: At 3-month postoperative study visit

Unsolicited visual or eye-related complaints volunteered by participants rather than specifically probed by the investigator. Serves as a secondary safety or tolerability measure to monitor unexpected sensory side effects. Quantified via non-leading, open-ended questioning during study visits or via non-directed adverse event logging
At 3-month postoperative study visit
Patient Recommendation and Satisfaction
Time Frame: At 3-month postoperative study visit

Patient Recommendation and Satisfaction (as recorded by the PQRS questionnaire). The questionnaire does not generate a scale-based or indexed score. Results are analyzed descriptively, capturing the frequency and distribution of specific visual complaints reported across the study population.
At 3-month postoperative study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Daniel H. Chang, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johnson & Johnson Surgical Vision, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Daniel H Chang, MD, Empire Eye and Laser Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EMP-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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