CataractNCT07898917
PureSee/Odyssey Mix-and-Match IOL
An observational study of Cataract, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
Observational, prospective, bilateral, single-arm investigator-initiated study. Single cohort at one site: TECNIS PureSee intraocular lens in the dominant eye and TECNIS Odyssey intraocular lens in the non-dominant eye. There is no control arm, and the study is not masked. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Mix-and-match PureSee/Odyssey cohort
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will comprise adult (age 35 or older) patients undergoing surgery for age-related cataract.
Who may be able to join
- Adult (age 35 or older) patients undergoing age-related cataract surgery.
Who cannot join
- Moderate-to-severe disease state, as deemed by the surgeon, that could increase the risk of complicated cataract surgery, including pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, and prior refractive surgery.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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
North Georgia Eye Associates
Gainesville, Georgia, 30501
Maryann Thomas, 770-532-4444, maryann.thomas@ngeye.com
Clayton Blehm, MD
About this study
Official title: Visual and Patient-Reported Outcomes After Mix-and-Match Implantation of an Extended Depth of Focus and a Trifocal Intraocular Lens
Observational, prospective, bilateral, single-arm investigator-initiated study. Single cohort at one site: TECNIS PureSee intraocular lens in the dominant eye and TECNIS Odyssey intraocular lens in the non-dominant eye. There is no control arm, and the study is not masked.
- Conditions
- Cataract
- Being tested
- Mix-and-match PureSee/Odyssey cohort
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mix-and-match PureSee/Odyssey cohortDevice
TECNIS PureSee intraocular lens in the dominant eye and a TECNIS Odyssey intraocular lens in the non-dominant eye
| Study group | Role | What they receive |
|---|---|---|
| Mix-and-match PureSee/Odyssey cohort | Not described Receives: Device: Mix-and-match PureSee/Odyssey cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular distance-corrected intermediate visual acuity at 66 cm (3 months postoperatively).
Measured: 3 months
Secondary outcomes (6)
Mean binocular corrected distance visual acuity (3 months postoperatively)
Measured: 3 months
Mean binocular uncorrected intermediate visual acuity at 66 cm (3 months postoperatively)
Measured: 3 months
Mean binocular uncorrected distance visual acuity (3 months postoperatively)
Measured: 3 months
Mean binocular distance-corrected near visual acuity at 40 cm (3 months postoperatively)
Measured: 3 months
Mean binocular uncorrected near visual acuity at 40 cm (3 months postoperatively)
Measured: 3 months
Binocular distance-corrected defocus curve from +1.0 D through -2.50 D (3 months postoperatively)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gainesville Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Clayton Blehm, MD, Principal investigator, North Georgia Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898917
- Sponsor's protocol ID
- CB-26-02
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Patient-Reported Outcomes After Mix-and-Match Implantation of an Extended Depth of Focus and a Trifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT07898917
- Acronym / sponsor ID
- CB-26-02
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Oct 2026 (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.
Observational, prospective, bilateral, single-arm investigator-initiated study. Single cohort at one site: TECNIS PureSee intraocular lens in the dominant eye and TECNIS Odyssey intraocular lens in the non-dominant eye. There is no control arm, and the study is not masked.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mix-and-match PureSee/Odyssey cohort | – | Device: Mix-and-match PureSee/Odyssey cohort |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise adult (age 35 or older) patients undergoing surgery for age-related cataract.
Key inclusion criteria (1 listed)
- Adult (age 35 or older) patients undergoing age-related cataract surgery.
Key exclusion criteria (3 listed)
- Moderate-to-severe disease state, as deemed by the surgeon, that could increase the risk of complicated cataract surgery, including pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, and prior refractive surgery.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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 |
|---|---|---|
| Mix-and-match PureSee/Odyssey cohortTECNIS PureSee intraocular lens in the dominant eye and a TECNIS Odyssey intraocular lens in the non-dominant eye | Device | Mix-and-match PureSee/Odyssey cohort |
Primary outcome
Binocular distance-corrected intermediate visual acuity at 66 cm (3 months postoperatively).
Time frame: 3 months
6 secondary outcomes
Mean binocular corrected distance visual acuity (3 months postoperatively)
Time frame: 3 months
Mean binocular uncorrected intermediate visual acuity at 66 cm (3 months postoperatively)
Time frame: 3 months
Mean binocular uncorrected distance visual acuity (3 months postoperatively)
Time frame: 3 months
Mean binocular distance-corrected near visual acuity at 40 cm (3 months postoperatively)
Time frame: 3 months
Mean binocular uncorrected near visual acuity at 40 cm (3 months postoperatively)
Time frame: 3 months
Binocular distance-corrected defocus curve from +1.0 D through -2.50 D (3 months postoperatively)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
Clayton Blehm, MD principal investigator
North Georgia Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Gainesville Eye Associates at 1 site 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryann Thomas, Study Staff (770-532-4444, maryann.thomas@ngeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular distance-corrected intermediate visual acuity at 66 cm (3 months postoperatively). (time frame: 3 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 27 Oct 2026.