Visual Outcomes of Vivity in Patients With Well Controlled Glaucoma

Outcomes of Vivity EDOF IOL Implantation in Patients With Well Controlled OAG or OHT

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
• Intervention / Treatment: Device: Vivity Extended Depth of Focus

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Paul Harasymowycz; Phone Number: 514-256-0007; Email: pavloh@igmtl.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1V 1G5
      • Recruiting
      • Clinique Bellevue
      • Contact: Nataliya Khrushch; Phone Number: (514) 256-1908; Email: nkhrushch@igmtl.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Prospective, single surgeon, single site (Clinique Bellevue, Montreal)
• Sample size: Single arm (n=30) 30 bilateral patients (60 eyes total)
• Patients who underwent bilateral cataract surgery with implantation of Vivity non-toric IOL (15-25D IOL spherical power)
• Binocular VA endpoints were evaluated at baseline and 3 months postop
• Visual disturbances (QUVID) and spectacle independence (IOLSAT) questionnaires to be administered at 3 months postop after implantation of second eye
• Barrett Universal II and Barrett Toric IOL Calculator (for determining exclusion if T3 or higher is calculated) were used for IOL calculation and targeted for emmetropia bilaterally for both groups

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular uncorrected visual acuity	Binocular uncorrected visual acuities at 6m distance will be measured	3 months
Binocular uncorrected visual acuity	Binocular uncorrected visual acuities at intermediate distance (66cm) will be measured	3 months
Binocular uncorrected visual acuity	Binocular uncorrected visual acuities at near distance (40cm) will be measured	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity, frequency of bothersomeness of starbursts, haloes, and glare	Severity, frequency of bothersomeness of starbursts, haloes, and glare will be evaluated using the QUVID questionnaire	3 months
Spectacle independence	Spectacle independence will be evaluated using the IOLSAT questionnaire	3 months
IOP	IOP will be measured in mmHg	1 day
IOP	IOP will be measured in mmHg	1 month
IOP (mmHg at 1 day, 1 month and 3 months)	IOP will be measured in mmHg	3 months
Mean refractive outcomes	Mean refractive outcomes (error and MRSE) will be evaluated	3 months
Refractive target accuracy	Percentage of eyes with an APE of 0.50D or less	Approximate patient follow-up time is 4 months following phacoemulsification and insertion of the study lens in the second eye. Time in between eyes will be approximately 1-2 months.
Contrast sensitivity	Contrast sensitivity will be evaluated using the Pelli-Robson Chart	pre-operation
Contrast sensitivity	Contrast sensitivity will be evaluated using the Pelli-Robson Chart	1 month
Contrast sensitivity	Contrast sensitivity will be evaluated using the Pelli-Robson Chart	3 months

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Paul Harasymowycz, Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: EDOF in POAG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The plan is to publish the study in an Ophthalmology journal and present the data at national and international ophthalmological conferences (ASCRS 2021/2022, AAO 2021/2022, COS 2022, CGS 2022)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes