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Not yet recruitingNCT07898917Updated Oct 27, 2026

PureSee/Odyssey Mix-and-Match IOL

An observational study in Cataract, sponsored by Gainesville Eye Associates. Not yet recruiting at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Gainesville Eye Associates · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
35 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,731 studies on the registry are indexed under Cataract; 233 are open to participants now.

This study's planned enrollment of 40 is below the median of 82 across 493 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Gainesville Eye Associates is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will comprise adult (age 35 or older) patients undergoing surgery for age-related cataract.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult (age 35 or older) patients undergoing age-related cataract surgery.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mix-and-match PureSee/Odyssey cohort

    Device: Mix-and-match PureSee/Odyssey cohort

Interventions

  • DeviceMix-and-match PureSee/Odyssey cohort

    TECNIS PureSee intraocular lens in the dominant eye and a TECNIS Odyssey intraocular lens in the non-dominant eye

06

What researchers measure

Primary outcomes

  1. Binocular distance-corrected intermediate visual acuity at 66 cm (3 months postoperatively).

    Time frame: 3 months

Secondary outcomes

  1. Mean binocular corrected distance visual acuity (3 months postoperatively)

    Time frame: 3 months

  2. Mean binocular uncorrected intermediate visual acuity at 66 cm (3 months postoperatively)

    Time frame: 3 months

  3. Mean binocular uncorrected distance visual acuity (3 months postoperatively)

    Time frame: 3 months

  4. Mean binocular distance-corrected near visual acuity at 40 cm (3 months postoperatively)

    Time frame: 3 months

  5. Mean binocular uncorrected near visual acuity at 40 cm (3 months postoperatively)

    Time frame: 3 months

  6. Binocular distance-corrected defocus curve from +1.0 D through -2.50 D (3 months postoperatively)

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07898917
Lead sponsor
Gainesville Eye Associates
Collaborators
Sengi
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 27, 2026

Study contacts

Maryann Thomas, Study Staff
Contact
maryann.thomas@ngeye.com
770-532-4444
Clayton Blehm, MD
principal investigator · North Georgia Eye Associates

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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