N/A Completed N=214 Randomized Double-blind Treatment

Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

Cataract

Source: ClinicalTrials.gov NCT05025345 ↗

Enrolled (actual)

214

Serious AEs

4.2%

Results posted

Aug 2023

Primary outcomePrimary: MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA) — -0.017; -0.029 LogMAR

Summary

This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL. The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.

Outcome Measures

Outcome	Result	p-value
PRIMARY MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)	-0.017; -0.029	—
SECONDARY MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)	0.235; 0.348	<0.0001 sig

Eligibility Criteria

Inclusion Criteria

Minimum 22 years of age
Bilateral cataracts for which posterior chamber IOL implantation has been planned
Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
Potential for postoperative best corrected visual acuity of 20/30 Snellen or better
Corneal astigmatism parameters:
Normal corneal topography and no irregular corneal astigmatism
Postoperative astigmatism can be surgically managed to be less than 1 D in each eye
Clear intraocular media other than cataract in each eye
Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
Ability to understand and respond to a questionnaire in English

Exclusion Criteria

Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
Desire for monovision correction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05025345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.