Comparison of Gemini III Rev 2 Implanted in Conjunction With an Approved IOL vs Eyes Implanted With an Approved IOL

Omega Ophthalmics

Status

Completed

Conditions

Cataract

Treatments

Device: Control Eye

Device: Omega Gemini III Rev 2 Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04059796

Gemini III Rev 2

Details and patient eligibility

About

This study is a prospective, observational, randomized, controlled, paired eye, subject-masked design.

Full description

Subjects will be randomly assigned to which eye will receive the Omega capsule Gemini 3 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 one of the Gemini capsules (both models) will be eligible to have a secondary procedure (post 1-month postoperative visit) to correct refractive error.

Enrollment

6 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 >2.8mm
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