Recruiting

Clareon TruPlus & Tecnis Eyhance

Sponsor:

Gainesville Eye Associates

Code:

NCT07658040

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clareon TruPlus

Tecnis Eyhance

Study Details

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.

Conditions

Cataract

Study ID

NCT07658040

Start date

Jul 20, 2026

Status verified date

Aug, 2026

Completion date

Aug 9, 2027

Anticipated

Primary completion date

Aug 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Clareon TruPlus

Tecnis Eyhance

Interventions

Clareon TruPlus

Bilateral implantation

Tecnis Eyhance

Bilateral implantation

Primary outcome measure

  • Binocular corrected distance visual acuity (CDVA) [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Central contacts

Maryann Thomas

770-532-4444maryann.thomas@ngeye.com

Locations

North Georgia Eye Associates

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

Maryann Thomas

770-532-4444mthomas@gainesvilleeye.com

Principal Investigator:

Clayton Blehm, MD

More Information

Sponsor

Gainesville Eye Associates

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gainesville Eye Associates on 2026-09-01.