Clinical Investigation of Omega Refractive Capsule, Model VI (ORCVI)

Omega Ophthalmics

Status

Active, not recruiting

Conditions

Cataract

Treatments

Device: FDA approved Intraocular Lens

Device: Omega Refractive Capsule with an FDA approved Intraocular Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT04574115

Omega Refractive Capsule VI

Details and patient eligibility

About

The objective of this study is to evaluate the safety and effectiveness of the investigational Omega Refractive Capsule (model VI)

Full 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).

Enrollment

30 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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