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

NCT04574102 | Completed

• 1 other identifier: Omega Refractive Capsule Mod V
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Absence of fusion of peripheral anterior and posterior capsule

  slit lamp exam

  6 Month Postoperative Visit

Study Arms (2)

Study Eye

EXPERIMENTAL

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

Device: Omega Refractive Capsule with FDA approved Intraocular Lens

Control Eye

ACTIVE COMPARATOR

FDA approved Intraocular Lens

Device: FDA approved Intraocular lens

Interventions

Omega Refractive Capsule with FDA approved Intraocular Lens DEVICE

Omega Refractive Capsule with FDA approved Intraocular Lens

Also known as: FDA approved intraocular lens

Study Eye

FDA approved Intraocular lens DEVICE

FDA approved Intraocular lens

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 \<2.5mm
• Prior ocular surgery
• Epiretinal membrane

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 treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: September 15, 2020
• First Posted: October 5, 2020
• Study Start: December 9, 2020
• Primary Completion: June 9, 2021
• Study Completion: November 15, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)