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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivity Extended Depth of Focus | Device | Cataract surgery |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Harasymowycz | Contact | 514-256-0007 | pavloh@igmtl.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Harasymowycz | Maisonneuve-Rosemont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Bellevue | Recruiting | Montreal | Quebec | H1V 1G5 | Canada |
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)
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 2, 2024 | |
| Reset | Sep 20, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2024 | Sep 20, 2024 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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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 |