Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients
ConditionCataract
Trial statusNot yet recruiting
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
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 design
Treatments tested in this trial
- Clareon TruPlus
- Tecnis Eyhance
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Gainesville Eye Associates
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov