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

September 15, 2020 updated by: Omega Ophthalmics

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

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

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study Eye
Study device in conjunction with an approved monofocal or toric IOL after cataract extraction
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
Control eyes will receive an approved monofocal or toric IOL post cataract extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens
Time Frame: 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.
6 month Postop Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2020

Primary Completion (ACTUAL)

August 28, 2020

Study Completion (ACTUAL)

August 28, 2020

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (ACTUAL)

August 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gemini III Rev 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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