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CompletedNCT04574102ORCVUpdated Apr 20, 2022

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

An interventional study of Omega Refractive Capsule with FDA approved Intraocular Lens and FDA approved Intraocular lens in Cataract, sponsored by Omega Ophthalmics. Completed at 1 site in Costa Rica. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by Omega Ophthalmics · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

investigational Omega Refractive Capsule (model V)

Read the 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).

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 6 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Omega Ophthalmics is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Study Eye

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

    Device: Omega Refractive Capsule with FDA approved Intraocular Lens

  • Active comparator
    Control Eye

    FDA approved Intraocular Lens

    Device: FDA approved Intraocular lens

Interventions

  • DeviceOmega Refractive Capsule with FDA approved Intraocular Lens

    Omega Refractive Capsule with FDA approved Intraocular Lens

    Also known as: FDA approved intraocular lens

  • DeviceFDA approved Intraocular lens

    FDA approved Intraocular lens

06

What researchers measure

Primary outcomes

  1. Absence of fusion of peripheral anterior and posterior capsule

    slit lamp exam

    Time frame: 6 Month Postoperative Visit

07

Study locations

1 site
  • Clinica 20/20
    San José, Costa Rica
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04574102
Lead sponsor
Omega Ophthalmics
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Dec 9, 2020
Primary completion
Jun 9, 2021
Completion
Nov 15, 2021
Last update
Apr 20, 2022

Study contacts

Claudio Orlich, MD
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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