Health TrialsbyHealthPanel

Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients

ConditionCataract
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGainesville Eye Associates

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clareon TruPlus

    Device

    Bilateral implantation

  • Tecnis Eyhance

    Device

    Bilateral implantation

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Clareon TruPlus1 intervention
Group B: Tecnis Eyhance1 intervention

Trial outcomes

Primary outcomes

1

Binocular corrected distance visual acuity (CDVA)

Time frame
3 months postoperatively

Secondary outcomes

1

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

Time frame
3 months postoperatively
2

Binocular uncorrected distance visual acuity (UDVA)

Time frame
3 months postoperatively

Other outcomes

1

Monocular photopic BCDVA with pinhole

dominant eye only, dilated with cyclopentolate 1%

Time frame
3 months postoperatively
2

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

Time frame
3 months postoperatively
3

Binocular photopic DCNVA (40cm)

Time frame
3 months postoperatively
4

Binocular photopic UDVA

Time frame
3 months postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gainesville Eye Associates

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov
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