Clinical Investigation of Omega Refractive Capsule, Model VI

NCT04574115 | Unknown

• 1 other identifier: Omega Refractive Capsule VI
• Study Type: interventional
• Target: 30
• 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 VI)

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Absence of fusion of peripheral anterior and posterior capsule

  slit lamp exam assessment

  6 Month Postoperative Visit

Study Arms (2)

Study Eye

EXPERIMENTAL

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

Control Eye

ACTIVE COMPARATOR

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

Device: FDA approved Intraocular Lens

Interventions

Omega Refractive Capsule with an FDA approved Intraocular Lens DEVICE

Omega refractive capsule in conjunction with an 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: subject 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 VI 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: February 6, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)