CataractNCT07658040
Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients
An observational study of Cataract, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
This study is a prospective, randomized, two-arm, single-center, single-surgeon, double-masked (subject and assessor) comparative study. It involves bilateral implantation of intraocular lenses (IOLs), comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in normal cataract patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon TruPlus and Tecnis Eyhance
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to 9 Aug 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with bilateral age-related cataracts eligible for planned bilateral cataract removal and IOL implantation.
Who may be able to join
- Willing and able to understand and sign informed consent.
- Adult patient diagnosed with age-related cataracts bilaterally.
- Planned bilateral cataract removal and with bilateral implantation of the Clareon TruPlus IOL/Toric BLF (T3-T5) or Tecnis Eyhance IOL/Eyhance Toric (equivalent to T3-T5).
- Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon.
- Residual astigmatism expected to be <= 0.50 diopters in both eyes postoperatively as determined by surgeon (After using either toric IOL or arcuate incision with laser or manual LRI).
- Normal ocular findings aside from cataract.
Who cannot join
- Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery including corneal refractive surgery.
- History of amblyopia or monofixation syndrome with poor stereoscopic vision.
- Participants desiring monovision.
- Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
- Participation in another clinical study that could interfere with the results.
- Any active ocular infection or inflammation.
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, 1 recruiting
- Recruiting
North Georgia Eye Associates
Gainesville, Georgia, 30501
Maryann Thomas, 770-532-4444, mthomas@gainesvilleeye.com
Clayton Blehm, MD
About this study
Official title: Visual and Patient Reported Outcomes Comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in Normal Cataract Patients: Stage 1
This study is a prospective, randomized, two-arm, single-center, single-surgeon, double-masked (subject and assessor) comparative study. It involves bilateral implantation of intraocular lenses (IOLs), comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in normal cataract patients. The study will be conducted at one site and will include a pre-operative visit and a 3-month post-operative assessment.
- Conditions
- Cataract
- Being tested
- Clareon TruPlus, Tecnis Eyhance
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon TruPlusDevice
Bilateral implantation
Tecnis EyhanceDevice
Bilateral implantation
| Study group | Role | What they receive |
|---|---|---|
| Clareon TruPlus | Not described Receives: Device: Clareon TruPlus | |
| Tecnis Eyhance | Not described Receives: Device: Tecnis Eyhance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular corrected distance visual acuity (CDVA)
Measured: 3 months postoperatively
Secondary outcomes (2)
Binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm
Measured: 3 months postoperatively
Binocular uncorrected distance visual acuity (UDVA)
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start20 Jul 2026
- Primary completion9 Aug 2027 (estimated)
- Study completion9 Aug 2027 (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
- 70 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
- NCT07658040
- Sponsor's protocol ID
- CB-26-01
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2026
- Last updated
- 1 Sep 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Patient Reported Outcomes Comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in Normal Cataract Patients: Stage 1
- ClinicalTrials.gov ID
- NCT07658040
- Acronym / sponsor ID
- CB-26-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 9 Aug 2027 (estimated)
- Study completion
- 9 Aug 2027 (estimated)
- First posted
- 18 Jun 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.
This study is a prospective, randomized, two-arm, single-center, single-surgeon, double-masked (subject and assessor) comparative study. It involves bilateral implantation of intraocular lenses (IOLs), comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in normal cataract patients. The study will be conducted at one site and will include a pre-operative visit and a 3-month post-operative assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon TruPlus | – | Device: Clareon TruPlus |
| Tecnis Eyhance | – | Device: Tecnis Eyhance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with bilateral age-related cataracts eligible for planned bilateral cataract removal and IOL implantation.
Key inclusion criteria (6 listed)
- Willing and able to understand and sign informed consent.
- Adult patient diagnosed with age-related cataracts bilaterally.
- Planned bilateral cataract removal and with bilateral implantation of the Clareon TruPlus IOL/Toric BLF (T3-T5) or Tecnis Eyhance IOL/Eyhance Toric (equivalent to T3-T5).
- Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon.
- Residual astigmatism expected to be <= 0.50 diopters in both eyes postoperatively as determined by surgeon (After using either toric IOL or arcuate incision with laser or manual LRI).
Key exclusion criteria (7 listed)
- Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery including corneal refractive surgery.
- History of amblyopia or monofixation syndrome with poor stereoscopic vision.
- Participants desiring monovision.
- Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
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 |
|---|---|---|
| Clareon TruPlusBilateral implantation | Device | Clareon TruPlus |
| Tecnis EyhanceBilateral implantation | Device | Tecnis Eyhance |
Primary outcome
Binocular corrected distance visual acuity (CDVA)
Time frame: 3 months postoperatively
2 secondary outcomes
Binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm
Time frame: 3 months postoperatively
Binocular uncorrected distance visual acuity (UDVA)
Time frame: 3 months postoperatively
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 1 Sep 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 Sep 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 (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 corrected distance visual acuity (CDVA) (time frame: 3 months postoperatively). 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 1 Sep 2026.