Clinical Investigation of OMEGA Gemini Capsule, Model Gemini IV With an Approved Monofocal or Toric IOL

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, randomized, controlled, paired eye, subject-masked design.

Detailed Description
-----------------
Subjects will be randomly assigned to which eye will receive the Omega capsule Gemini IV with an approved monofocal or Toric intraocular lens. Fellow eyes will receive an approved monofocal or Toric IOL (no Omega capsule). Eyes randomized to receive the Gemini capsule will be eligible to have a secondary procedure (post 1-month postoperative visit) to correct refractive error.

Official Title
-----------------
Clinical Investigation of OMEGA Gemini Capsule, Model Gemini IV in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens (The Gemini IV Trial)

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

Intervention / Treatment
-----------------
* Device: Gemini IV
* Device: Control Eye


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 >2.8mm Extremely shallow anterior chamber <2.0mm 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Eye<br>Randomized eyes will receive a Gemini IV device in conjunction with an approved monofocal or toric IOL after cataract extraction | Device: Gemini IV<br>* Eyes randomized to receive the Gemini IV device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction<br>|
| Active Comparator: Control Eye<br>control eyes will received an approved monofocal or toric IOL after cataract extraction | Device: Control Eye<br>* Control eyes will receive an approved monofocal or toric IOL post cataract extraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens | Via dilated slit lamp examination subjects will be assessed for anterior and posterior fusion of the IOL to the capsular bag with a dichotomous Yes/No response. | 6 month postop Visit |