Presbyopia CorrectionPhase 4NCT07860567
Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match
A Phase 4 study testing TECNIS PureSee IOL (Model DEN00V/DET150) and TECNIS Odyssey IOL (Model DRN00V/DRT150) in people with Presbyopia Correction and Presbyopia, run by Dr. Daniel H. Chang, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Presbyopia Correction, Presbyopia, Dysphotopsia
- What is being tested?
- TECNIS PureSee IOL (Model DEN00V/DET150) and TECNIS Odyssey IOL (Model DRN00V/DRT150)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Mar 2027
- Phase
- Phase 4
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 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Empire Eye and Laser Center
Bakersfield, California, 93309
Brittany Camirand, BSc, CCRC, COA, 661-325-3937 ext. 203, bcamirand@empireeyeandlaser.com
Isabelle Edgington, COA, 661-325-3937 ext. 203, iedgington@empireeyeandlaser.com
About this study
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.
Read the 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.
- Conditions
- Presbyopia Correction, Presbyopia, Dysphotopsia, Visual Acuity
- Being tested
- TECNIS PureSee IOL (Model DEN00V/DET150), TECNIS Odyssey IOL (Model DRN00V/DRT150)
- Keywords
- Presbyopia, Presbyopia Correction, Intraocular Lens, Cataract, Dysphotopsia, Spectacle Independence, Extended Depth of Focus, Depth of Field, Range of Vision, IOL, Halometry, TECNIS PureSee IOL, TECNIS Odyssey IOL, PRVSQ, PRSIQ
- Medical subject headings
- Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECNIS PureSee IOL (Model DEN00V/DET150)Device
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).
TECNIS PureSee IOL (Model DEN00V/DET150)Device
Implantation of the TECNIS PureSee intraocular lens into the dominant eye following standard phacoemulsification cataract surgery.
TECNIS Odyssey IOL (Model DRN00V/DRT150)Device
Implantation of the TECNIS Odyssey intraocular lens into the non-dominant eye following standard phacoemulsification cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Mini-Monovision (TECNIS PureSee) | Experimental | 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. Receives: Device: TECNIS PureSee IOL (Model DEN00V/DET150) |
| Mix-Match (TECNIS PureSee + TECNIS Odyssey) | Experimental | 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. Receives: Device: TECNIS PureSee IOL (Model DEN00V/DET150); Device: TECNIS Odyssey IOL (Model DRN00V/DRT150) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular UCDVA
Binocular Uncorrected Distance Visual Acuity
Measured: At 3-month postoperative study visit
Secondary outcomes (4)
Binocular UCIVA
Binocular Uncorrected Intermediate Visual Acuity
Measured: At 3-month postoperative study visit
Binocular UCNVA
Binocular Uncorrected Near Visual Acuity
Measured: At 3-month postoperative study visit
Patient Reported Outcomes PRVSQv2
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.
Measured: At 3-month postoperative study visit
Patient Reported Outcomes PRSIQv2
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.
Measured: At 3-month postoperative study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presbyopia CorrectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One mini-monovision arm, and one mix-match arm.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Daniel H. Chang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Responsible party
- Sponsor-investigator, Dr. Daniel H. Chang, MD, Empire Eye and Laser Center
- Investigators
- Daniel H Chang, MD, Study director, Empire Eye and Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860567
- Sponsor's protocol ID
- EMP-2026-001
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No