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

NCT ID: NCT04058314

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2020-08-28

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study Eye

Randomized eyes will receive a Gemini IV device in conjunction with an approved monofocal or toric IOL after cataract extraction

Group Type: EXPERIMENTAL

Gemini IV

Intervention Type: DEVICE

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

Control Eye

control eyes will received an approved monofocal or toric IOL after cataract extraction

Group Type: ACTIVE_COMPARATOR

Control Eye

Intervention Type: DEVICE

Control eyes will receive an approved monofocal or toric IOL post cataract extraction

Interventions

Gemini IV

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

Intervention Type: DEVICE

Control Eye

Control eyes will receive an approved monofocal or toric IOL post cataract extraction

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Omega Ophthalmics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Orlich, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica 20/20

San José, , Costa Rica

Countries

Costa Rica

Other Identifiers

Gemini IV

Identifier Type: -

Identifier Source: org_study_id