Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients

NCT07658040 | Not Yet Recruiting FDA Device

• 1 other identifier: CB-26-01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Binocular corrected distance visual acuity (CDVA)

  3 months postoperatively

Secondary Outcomes (2)

• Binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm

  3 months postoperatively

• Binocular uncorrected distance visual acuity (UDVA)

  3 months postoperatively

Other Outcomes (13)

• Monocular photopic BCDVA with pinhole

  3 months postoperatively

• Binocular AULCSF (area under the log contrast sensitivity function) under photopic conditions without glare

  3 months postoperatively

• Binocular photopic DCNVA (40cm)

  3 months postoperatively

Study Arms (2)

Clareon TruPlus

Device: Clareon TruPlus

Tecnis Eyhance

Device: Tecnis Eyhance

Interventions

Clareon TruPlus DEVICE

Bilateral implantation

Clareon TruPlus

Tecnis Eyhance DEVICE

Bilateral implantation

Tecnis Eyhance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with bilateral age-related cataracts eligible for planned bilateral cataract removal and IOL implantation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gainesville Eye Associates: lead
• Sengi: collaborator

Study Sites (1)

North Georgia Eye Associates

Gainesville, Georgia, 30501, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Clayton Blehm, MD

  North Georgia Eye Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryann Thomas

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): August 9, 2026
• Primary Completion (Estimated): August 9, 2027
• Study Completion (Estimated): August 9, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)