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

NCT04058314 | Completed

• 1 other identifier: Gemini IV
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study Eye

EXPERIMENTAL

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

Device: Gemini IV

Control Eye

ACTIVE COMPARATOR

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

Device: Control Eye

Interventions

Gemini IV 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

Study Eye

Control Eye DEVICE

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

Control Eye

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Omega Ophthalmics: lead

Study Sites (1)

Clinica 20/20

San José, Costa Rica

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Claudio Orlich, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be masked to the eye that receives the study device
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: February 21, 2020
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)