Cataracts Clinical Trial
Official title:
The Incidence of Glistenings in the 2017 Generation of Hydrophobic Acrylic Lenses Manufactured by Alcon and Abbott Medical Optics
Verified date | December 2023 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to seek academic/non-industry research funding support to independently investigate the incidence and density of lens glistenings in cataract patients who are implanted with the latest generations of intraocular lenses (IOL) manufactured by Alcon and AMO Medical Optics.
Status | Terminated |
Enrollment | 22 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients consulting 5 surgeons for cataract surgery in the surgeon's primary offices - Patients aged 18 years or older - Patients who signed the consent form Exclusion Criteria: - Individuals who cannot understand English in either written or verbal form and do not have language assistance available (e.g. from family members, friends) - Patients with co-existing condition of corneal disease - Patients with co-existing condition of uveitis - Patients with co-existing condition of optic nerve disease - Patients with co-existing condition of macular disease - Patients with co-existing condition of diabetes - Patients with co-existing condition of severe glaucoma (i.e. C/D ratio >=0.9 AND the patient is on glaucoma treatment) - Patients with prior refractive surgery - Patients with complications of cataract surgery occurred during or after surgery |
Country | Name | City | State |
---|---|---|---|
Canada | Kensington Eye Institute | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | Kensington Eye Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and density (severity) of glistenings at 18-month follow-up visit | To determine if glistenings develop, eyes are dilated and examined. Photographs of the IOLs will be taken with a slit lamp camera for documentation. These photographs will then be assessed for glistenings in two ways: first by trained ophthalmology staff, and second using the ImageJ software
Glistenings will be counted and graded on a scale of 0 to 5+ as following: 0. No glistening Less than 10 glistenings 10 to 25 glistenings 25 to 50 glistenings 50 to 100 glistenings Greater than 100 glistenings |
18-month follow-up | |
Secondary | Visual acuity in eyes with glistenings at 18-month follow-up visit | Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart. | 18 month follow-up | |
Secondary | Contrast sensitivity in eyes with glistenings at 18-month follow-up visit | Contrast sensitivity: the ability of the visual system to distinguish between an object and its background. This will be tested with the Vector Vision CSV-1000HGT. | 18 month follow-up | |
Secondary | Glare disability in eyes with glistenings at 18-month follow-up visit | Glare disability: the difficulty seeing in the presence of very bright light such as night-time lighting or sunshine. This will be tested using the Brightness Acuity Tester (BAT). | 18 month follow-up | |
Secondary | Visual acuity in eyes with glistenings at 12-month follow-up visit | Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart | 12-month follow-up | |
Secondary | Contrast sensitivity and glare disability in eyes with glistenings at 12-month follow-up visit | Contrast sensitivity: the ability of the visual system to distinguish between an object and its background. This will be tested with the Vector Vision CSV-1000HGT. | 12-month follow-up | |
Secondary | Glare disability in eyes with glistenings at 12-month follow-up visit | Glare disability: the difficulty seeing in the presence of very bright light such as night-time lighting or sunshine. This will be tested using the Brightness Acuity Tester (BAT). | 12-month follow-up | |
Secondary | Visual acuity in eyes with glistenings at 6-month follow-up visit | Best corrected visual acuity: acuteness/clearness of vision. This will be tested with the ETDRS (early treatment diabetic retinopathy study) chart. | 6-month follow-up | |
Secondary | Contrast sensitivity in eyes with glistenings at 6-month follow-up visit | Contrast sensitivity: the ability of the visual system to distinguish between an object and its background. This will be tested with the Vector Vision CSV-1000HGT. | 6-month follow-up | |
Secondary | Glare disability in eyes with glistenings at 6-month follow-up visit | Glare disability: the difficulty seeing in the presence of very bright light such as night-time lighting or sunshine. This will be tested using the Brightness Acuity Tester (BAT). | 6-month follow-up | |
Secondary | Incidence of glistenings at 12-month follow-up visit | To determine if glistenings develop, eyes are dilated and examined. Photographs of the IOLs will be taken with a slit lamp camera for documentation. These photographs will then be assessed for glistenings in two ways: first by trained ophthalmology staff, and second using the ImageJ software
Glistenings will be counted and graded on a scale of 0 to 5+ as following: 0. No glistening Less than 10 glistenings 10 to 25 glistenings 25 to 50 glistenings 50 to 100 glistenings Greater than 100 glistenings |
12-month follow-up | |
Secondary | Incidence of glistenings at 6-month follow-up visit | To determine if glistenings develop, eyes are dilated and examined. Photographs of the IOLs will be taken with a slit lamp camera for documentation. These photographs will then be assessed for glistenings in two ways: first by trained ophthalmology staff, and second using the ImageJ software
Glistenings will be counted and graded on a scale of 0 to 5+ as following: 0. No glistening Less than 10 glistenings 10 to 25 glistenings 25 to 50 glistenings 50 to 100 glistenings Greater than 100 glistenings |
6-month follow-up |
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