H25 H26
Conditions
Interventions
Group 1: Investigational 1-Piece Aspheric Acrylic Posterior Chamber IOL (IntraOcular Lens) for Cataract Surgery, Model MER002.
Each subject will undergo contralateral-implantation with the test IOL
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: • Minimum 22 years of age • Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned for both eyes • Potential for postoperative best corrected distance visual acuity of 20/30 Snellen or better • Clear intraocular media other than cataract in each eye • Availability, willingness, sufficient cognitive awareness to comply with examination procedures • Signed informed consent and documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
Exclusion criteria
Exclusion criteria: • Requiring an intraocular lens power outside the available range of +10.0 D to +25.0 D • Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils); unable to dilate to approximately 6.0 mm or more • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject • Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery • Subjects with conditions that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse during the study in the opinion of the investigator • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects • Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery or to take postoperative slit-lamp photographs) • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) • Poorly-controlled diabetes • Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (including patients with moderate narrow angles that could have angle closure during pupillary dilation) • Concurrent participation in any other clinical trial or participation within 30 days prior to the preoperative visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Paired mean difference in IOL rotation between test and control IOL at 1 month • Success criteria: Statistically significant improvement in mean rotational stability for Model MER002 eyes vs. control eyes. • Data will be collected as photographic evaluation of the IOL rotation at pre-op, post-op, and 1 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome | — |
Countries
Dominican Republic, El Salvador, Philippines
Contacts
Public ContactLeAnne Connolly
Johnson & Johnson Surgical Vision, Inc.
Outcome results
None listed