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

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 Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon TruPlus; Device: Tecnis Eyhance

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Maryann Thomas; Phone Number: 770-532-4444; Email: maryann.thomas@ngeye.com

Study Locations

• United States
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • North Georgia Eye Associates
      • Contact: Maryann Thomas; Phone Number: 770-532-4444; Email: mthomas@gainesvilleeye.com
      • Principal Investigator: Clayton Blehm, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clareon TruPlus	Device: Clareon TruPlus; Bilateral implantation
Tecnis Eyhance	Device: Tecnis Eyhance; Bilateral implantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular photopic BCDVA with pinhole	dominant eye only, dilated with cyclopentolate 1%	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
Binocular photopic UDVA		3 months postoperatively
Binocular photopic UIVA (66cm)		3 months postoperatively
Binocular mesopic BCDVA		3 months postoperatively
Binocular mesopic DCIVA (66cm)		3 months postoperatively
Binocular mesopic DCIVA (66cm)	Monocular distance corrected defocus curve (dominant eye)	3 months postoperatively
Binocular AULCSF (area under the log contrast sensitivity function) under mesopic conditions		3 months postoperatively
Pupil size (in mm)	Measured with a pupilometer	3 months postoperatively
Manifest Refraction (in diopters)		3 months postoperatively
Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	3 months postoperatively
Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperatively

Collaborators and Investigators

• Sponsor: Gainesville Eye Associates
• Collaborators: Sengi
• Investigators: Principal Investigator: Clayton Blehm, MD, North Georgia Eye Associates

Study record dates

Study Major Dates

• Study Start (Estimated): August 9, 2026
• Primary Completion (Estimated): August 9, 2027
• Study Completion (Estimated): August 9, 2027

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CB-26-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes