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ORCV: Clinical Investigation of Omega Refractive Capsule Model V With Use of an FDA Approved IOL

Sponsor
Omega Ophthalmics (Industry)
Overall Status
Completed
CT.gov ID
NCT04574102
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
11.2
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the

investigational Omega Refractive Capsule (model V)

Condition or Disease Intervention/Treatment Phase
  • Device: Omega Refractive Capsule with FDA approved Intraocular Lens
  • Device: FDA approved Intraocular lens
 N/A

Detailed Description

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

Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design. Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design. Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
Masking:
Single (Participant)
Masking Description:
subjects will be masked to treatment
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of Omega Refractive Capsule, Model V in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens
Actual Study Start Date :
Dec 9, 2020
Actual Primary Completion Date :
Jun 9, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Eye

Omega Refractive capsule, model V, with an FDA approved intraocular lens.

Device: Omega Refractive Capsule with FDA approved Intraocular Lens
Omega Refractive Capsule with FDA approved Intraocular Lens
Other Names:
  • FDA approved intraocular lens

    		•
    Active Comparator: Control Eye

    FDA approved Intraocular Lens

    Device: FDA approved Intraocular lens
    FDA approved Intraocular lens

    Outcome Measures

    Primary Outcome Measures

    1. Absence of fusion of peripheral anterior and posterior capsule [6 Month Postoperative Visit]

      slit lamp exam

    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 <2.5mm

    • 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:
    NCT04574102
    Other Study ID Numbers:
    • Omega Refractive Capsule Mod V
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Apr 20, 2022