Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients

Visual and Patient Reported Outcomes Comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in Normal Cataract Patients: Stage 1

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07658040

Enrollment

Registered

2026-06-18

Start date

2026-07-20

Completion date

2027-08-09

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief 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. The study will be conducted at one site and will include a pre-operative visit and a 3-month post-operative assessment.

Interventions

DEVICEClareon TruPlus

Bilateral implantation

DEVICETecnis Eyhance

Bilateral implantation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Binocular corrected distance visual acuity (CDVA)	3 months postoperatively

Secondary

Measure	Time frame
Binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm	3 months postoperatively
Binocular uncorrected distance visual acuity (UDVA)	3 months postoperatively

Countries

United States

Contacts

CONTACTMaryann Thomas

maryann.thomas@ngeye.com770-532-4444

PRINCIPAL_INVESTIGATORClayton Blehm, MD

North Georgia Eye Associates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026