Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes.
Ability to understand and sign an ethics committee-approved informed consent form.
Willingness and ability to attend all scheduled study visits as required by the protocol.
Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy.
Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma).
Participation in another clinical study that could interfere with the results.
Berkeley Eye Center
Lead sponsor
Sengi
Collaborator