Clinical Investigation of Omega Refractive Capsule, Model VI

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and effectiveness of the investigational Omega Refractive Capsule (model VI)

Detailed Description
-----------------
This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design. Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule VI with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).

Official Title
-----------------
Clinical Investigation of Omega Refractive Capsule, Model VI in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Omega Refractive Capsule with an FDA approved Intraocular Lens
* Device: FDA approved Intraocular Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 years of age or older at the time of surgery diagnosed with bilateral cataracts Able to understand and sign an informed consent Willing and able to complete all study visits and assessments required for the study Calculated lens power within the available range Corrected distance visual acuity is equal to or worse than 20/40 in each eye with or without a glare source present Bilateral cataracts eligible for extraction by phacoemulsification and capsular bag fixated IOL implantation Potential postop visual acuity of 20/25 or better in the judgment of the surgeon Preoperative corneal astigmatism of 4.0 D or less with normal corneal topography Clear intraocular media other than cataract Preop endothelial cell density of 2000 cells/mm2 or more Exclusion Criteria: Subject's best corrected vision is light perception or no light perception in either eye Cataract opacification preventing adequate Binocular Indirect Ophthalmoscopic retinal and macular examination. Orbital abnormalities, such as thyroid related orbitopathy, causing significant exophthalmos. Eyelid abnormalities causing lagophthalmos. Significant anterior blepharitis or meibomian gland dysfunction Corneal abnormalities or conditions, other than regular topographic corneal astigmatism Krukenburg's spindle (linear pigmentary deposits on the corneal endothelium) Abnormalities of the iris including trans-illumination defects Pupil abnormalities (abnormally shaped, fixed or non-reactive) Pharmacologic dilation less than 7 mm Axial length <22.5mm Lens thickness <4.1 mm Anterior chamber depth <2.5mm Prior ocular surgery Epiretinal membrane Macular edema Retinal tears including operculated holes Amblyopia Glaucoma of any kind Pseudoexfoliation syndrome History of uveitis/iritis Diabetic retinopathy Acute, chronic or uncontrolled systemic or ocular disease that may confound the results of the study (including rheumatologic conditions such as Rheumatoid arthritis, ankylosing spondyliltis, Sjögren's syndrome, and neurologic conditions such as optic neuritis or multiple sclerosis). Prior or anticipated use of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) or similar medications Average Keratometry <38D or > 48D by topography Any pathology of the zonules including evidence of zonular weakness, zonular instability, zonular damage, or coloboma effecting zonules. History of ocular trauma Pregnant, lactating, or has another condition with associated fluctuation of hormones that could lead to refractive changes

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design. Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule VI with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Eye<br>study eye will receive the Omega Refractive capsule VI with an FDA approved intraocular lens. | Device: Omega Refractive Capsule with an FDA approved Intraocular Lens<br>* Omega refractive capsule in conjunction with an FDA approved Intraocular Lens<br>|
| Active Comparator: Control Eye<br>Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule). | Device: FDA approved Intraocular Lens<br>* FDA approved Intraocular Lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of fusion of peripheral anterior and posterior capsule | slit lamp exam assessment | 6 Month Postoperative Visit |