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Visual and Patient Reported Outcomes Comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in Normal Cataract Patients: Stage 1

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Georgia
North Georgia Eye Associates
RECRUITING
Gainesville
Contact Information
Primary
Maryann Thomas
maryann.thomas@ngeye.com
770-532-4444
Time Frame
Start Date: 2026-07-20
Estimated Completion Date: 2027-08-09
Participants
Target number of participants: 70
Treatments
Clareon TruPlus
Tecnis Eyhance
Related Therapeutic Areas
Sponsors
Collaborators: Sengi
Leads: Gainesville Eye Associates

This content was sourced from clinicaltrials.gov