Clinical Investigation of Omega Refractive Capsule, Model VI (ORCVI)

Clinical Investigation of Omega Refractive Capsule, Model VI in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens

The objective of this study is to evaluate the safety and effectiveness of the investigational Omega Refractive Capsule (model VI)

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Omega Refractive Capsule with an FDA approved Intraocular Lens; Device: FDA approved Intraocular Lens

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 VI with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Costa Rica
  • San José, Costa Rica
    • Clinica 20/20

Participation Criteria

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 <2.5mm
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Eye; study eye will receive the Omega Refractive capsule VI with an FDA approved intraocular lens.	Device: Omega Refractive Capsule with an FDA approved Intraocular Lens; Omega refractive capsule in conjunction with an FDA approved Intraocular Lens
Active Comparator: Control Eye; Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).	Device: FDA approved Intraocular Lens; FDA approved Intraocular Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of fusion of peripheral anterior and posterior capsule	slit lamp exam assessment	6 Month Postoperative Visit

Collaborators and Investigators

• Sponsor: Omega Ophthalmics

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Omega Refractive Capsule VI

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