Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clareon TruPlus, Tecnis Eyhance.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Visual and Patient Reported Outcomes Comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in Normal Cataract Patients: Stage 1
Overview
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
- Device Clareon TruPlus
Bilateral implantation - Device Tecnis Eyhance
Bilateral implantation
Primary outcome measures
- Binocular corrected distance visual acuity (CDVA) [Time frame: 3 months postoperatively]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- North Georgia Eye Associates — Gainesville
Identifiers
NCT: NCT07658040 · CB-26-01