MedDataX Logo

Visual Outcomes of Vivity in Patients With Well Controlled Glaucoma

NCT ID: NCT05075226

Last Updated: 2021-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-29

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Glaucoma is a progressive optic neuropathy that results in a loss of contrast sensitivity and visual field if not detected and treated. When glaucoma patients undergo cataract surgery, they are often not ideal candidates for many existing presbyopia correcting IOLs as they reduce contrast sensitivity because of the splitting of light and are more likely to have visual disturbances secondary to diffractive steps in the IOL design. This is largely because of a higher rate of ocular surface disease and meibomian gland dysfunction in this patient population due to the chronic utilization of topical drops. As a result of this, patients with glaucoma currently receive aspheric monofocal IOLs during cataract surgery, which are lenses with minimal loss of contrast sensitivity but only one point of focus (typically targeted for distance). This necessitates the use of glasses for near and intermediate vision and has an impact on quality of life for these patients.

The Vivity Extended Depth of Focus (EDOF) IOL is a new technology that maintains uncompromised distance vision and provides improved intermediate vision correction, reducing the need for glasses. This lens uses a new optical system with no diffractive steps in the IOL; trials in non-glaucomatous patients have shown the rate of visual aberrations to be comparable to an aspheric monofocal IOL which are currently the standard of care in patients with glaucoma. There is no published data on outcomes of this IOL in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT). Studies are required to evaluate the clinical success of this new lens technology in glaucomatous patients. This will be the first study in Canada to report clinical outcomes of the Vivity IOL in this patient cohort.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vivity Extended Depth of Focus

Cataract surgery

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age greater than 18 years
* Patients undergoing uncomplicated cataract surgery with IOL implantation
* Patients with both eyes that calculate for IOL powers in the following ranges: 15-25D spherical power (for Vivity)
* Patients possessing with-the-rule or against-the-rule astigmatism ≤2.50 D
* Well controlled OAG or OHT defined as IOP less than or equal to 18mmHg
* Mild to moderate glaucoma as defined by MD VF loss less than 12 dB and no VF defect within the central 5 degrees with 0dB or less than 15dB of both hemi-fields in the central 5 degrees

Exclusion Criteria

* Ocular comorbidity that might hamper post-operative visual acuity (ie. Macular degeneration, macular edema, uveitis, corneal dystrophy, diabetic retinopathy)
* Ocular trauma or zonula instability
* Previous refractive surgery
* Irregular corneal astigmatism and keratoconus
* Difficulties comprehending written or spoken English or French language
* Patients with physical or intellectual disability
* Patients unable to fixate
* Patients with uncontrolled glaucoma or advanced glaucoma
* Patients that are undergoing filtration or tube surgery or MIGS devices for glaucoma
* Patients with previous filtration or tube surgery for glaucoma
* Patients with unreliable biometry
* Severe dry eye disease or ocular surface disease
* Patients where Barrett Toric Calculator recommends T5 or higher toric IOL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Paul Harasymowycz

MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Harasymowycz

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique Bellevue

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paul Harasymowycz

Role: CONTACT

[email protected]
514-256-0007

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nataliya Khrushch

Role: primary

[email protected]
(514) 256-1908

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EDOF in POAG

Identifier Type: -

Identifier Source: org_study_id