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

Sponsor

Omega Ophthalmics (Industry)

Overall Status

Completed

CT.gov ID

NCT04059796

Collaborator

(none)

Enrollment

Location

Arms

6.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Omega Gemini III Rev 2 Device Device: Control Eye	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Subjects will be masked to which eye receives the study device

Primary Purpose:

Treatment

Official Title:

Clinical Investigation of OMEGA Gemini Capsule, Model Gemini Capsule 3 Rev 2 in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens

Actual Study Start Date :

Feb 21, 2020

Actual Primary Completion Date :

Aug 28, 2020

Actual Study Completion Date :

Aug 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Eye Study device in conjunction with an approved monofocal or toric IOL after cataract extraction	Device: Omega Gemini III Rev 2 Device Eyes randomized to receive the Gemini III Rev 2 device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction
Active Comparator: Control Eye approved monofocal or toric IOL after cataract extraction	Device: Control Eye Control eyes will receive an approved monofocal or toric IOL post cataract extraction

Arm

Intervention/Treatment

Experimental: Study Eye

Study device in conjunction with an approved monofocal or toric IOL after cataract extraction

Device: Omega Gemini III Rev 2 Device

Eyes randomized to receive the Gemini III Rev 2 device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction

Active Comparator: Control Eye

approved monofocal or toric IOL after cataract extraction

Device: Control Eye

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

Outcome Measures

Primary Outcome Measures

Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens [6 month Postop Visit]
Via dilated slit lamp examination subjects will be assessed for anterior and posterior 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica 20/20	San José		Costa Rica

Sponsors and Collaborators

Omega Ophthalmics

Investigators

Principal Investigator: Claudio Orlich, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omega Ophthalmics

ClinicalTrials.gov Identifier:

NCT04059796

Other Study ID Numbers:

Gemini III Rev 2

First Posted:

Aug 16, 2019

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Sep 16, 2020