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

Cataract Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058314
• Other study ID #: Gemini IV
• Status: Completed
• Phase: N/A
• Start date: February 21, 2020
• Est. completion date: August 28, 2020

Study information

• Verified date: September 2020
• Source: Omega Ophthalmics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 28, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 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
• Control Eye
Control eyes will receive an approved monofocal or toric IOL post cataract extraction

Locations

Country	Name	City	State
Costa Rica	Clinica 20/20	San José

Sponsors (1)

Lead Sponsor	Collaborator
Omega Ophthalmics

Country where clinical trial is conducted

Costa Rica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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