Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)NCT05075226
Visual Outcomes of Vivity in Patients With Well Controlled Glaucoma
An observational study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT), run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
- What is being tested?
- Vivity Extended Depth of Focus
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Clinique Bellevue
Montreal, Quebec, H1V 1G5
Nataliya Khrushch, (514) 256-1908, nkhrushch@igmtl.com
About this study
Official title: 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.
- Being tested
- Vivity Extended Depth of Focus
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivity Extended Depth of FocusDevice
Cataract surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular uncorrected visual acuity
Binocular uncorrected visual acuities at 6m distance will be measured
Measured: 3 months
Binocular uncorrected visual acuity
Binocular uncorrected visual acuities at intermediate distance (66cm) will be measured
Measured: 3 months
Binocular uncorrected visual acuity
Binocular uncorrected visual acuities at near distance (40cm) will be measured
Measured: 3 months
Secondary outcomes (10)
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
Measured: 3 months
Spectacle independence
Spectacle independence will be evaluated using the IOLSAT questionnaire
Measured: 3 months
IOP
IOP will be measured in mmHg
Measured: 1 day
IOP
IOP will be measured in mmHg
Measured: 1 month
IOP (mmHg at 1 day, 1 month and 3 months)
IOP will be measured in mmHg
Measured: 3 months
Mean refractive outcomes
Mean refractive outcomes (error and MRSE) will be evaluated
Measured: 3 months
Refractive target accuracy
Percentage of eyes with an APE of 0.50D or less
Measured: 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
Measured: pre-operation
Contrast sensitivity
Contrast sensitivity will be evaluated using the Pelli-Robson Chart
Measured: 1 month
Contrast sensitivity
Contrast sensitivity will be evaluated using the Pelli-Robson Chart
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start29 Jul 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Harasymowycz, Maisonneuve-Rosemont Hospital
- Investigators
- Paul Harasymowycz, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075226
- Sponsor's protocol ID
- EDOF in POAG
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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)
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Vivity EDOF IOL Implantation in Patients With Well Controlled OAG or OHT
- ClinicalTrials.gov ID
- NCT05075226
- Acronym / sponsor ID
- EDOF in POAG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivity Extended Depth of FocusCataract surgery | Device | – |
Primary outcome
Binocular uncorrected visual acuity
Time frame: 3 months
Binocular uncorrected visual acuities at 6m distance will be measured
Binocular uncorrected visual acuity
Time frame: 3 months
Binocular uncorrected visual acuities at intermediate distance (66cm) will be measured
Binocular uncorrected visual acuity
Time frame: 3 months
Binocular uncorrected visual acuities at near distance (40cm) will be measured
10 secondary outcomes
Severity, frequency of bothersomeness of starbursts, haloes, and glare
Time frame: 3 months
Spectacle independence
Time frame: 3 months
IOP
Time frame: 1 day
IOP
Time frame: 1 month
IOP (mmHg at 1 day, 1 month and 3 months)
Time frame: 3 months
Mean refractive outcomes
Time frame: 3 months
Refractive target accuracy
Time frame: 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
Time frame: pre-operation
Contrast sensitivity
Time frame: 1 month
Contrast sensitivity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: No. 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)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Harasymowycz principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT), run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Harasymowycz (514-256-0007, pavloh@igmtl.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular uncorrected visual acuity (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.