search
Back to results

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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Costa Rica
Study Type
Interventional
Intervention
Gemini IV
Control Eye
Sponsored by
Omega Ophthalmics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Clinica 20/20

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Eye

Control Eye

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2019
Last Updated
September 15, 2020
Sponsor
Omega Ophthalmics
search

1. Study Identification

Unique Protocol Identification Number
NCT04058314
Brief Title
Clinical Investigation of OMEGA Gemini Capsule, Model Gemini IV With an Approved Monofocal or Toric IOL
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2020 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
August 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omega Ophthalmics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Subjects will be masked to the eye that receives the study device
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Eye
Arm Type
Experimental
Arm Description
Randomized eyes will receive a Gemini IV device in conjunction with an approved monofocal or toric IOL after cataract extraction
Arm Title
Control Eye
Arm Type
Active Comparator
Arm Description
control eyes will received an approved monofocal or toric IOL after cataract extraction
Intervention Type
Device
Intervention Name(s)
Gemini IV
Intervention Description
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
Intervention Name(s)
Control Eye
Intervention Description
Control eyes will receive an approved monofocal or toric IOL post cataract extraction
Primary Outcome Measure Information:
Title
Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens
Description
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.
Time Frame
6 month postop Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Orlich, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica 20/20
City
San José
Country
Costa Rica

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs