The Incidence of Glistenings in the 2017 Intraocular Lenses Made by Alcon and Abbott Medical Optics

Study Overview
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Brief Summary
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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.

Detailed Description
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Glistenings are tiny, clear sparkling, fluid-filled microvacuoles that form within a lens after it has been placed in the eye. Glistenings are seen in all lenses but certain lenses develop a higher number of glistenings than others. The effect of glistenings on patients' visual functioning is largely unknown. The occurrence of glistenings is in part related to the manufacturing technique. In 2013, manufacturers have claimed that recent improvements in manufacturing process have reduced the occurrence of glistenings. There is a lack of independent evaluation of this claim. We would like to assess independently: 1) How frequently do glistenings occur in patients implanted with the 2015 generation lenses? 2) Is there a difference in glistening occurrence between lenses manufactured by Alcon and Abbott Medical Optics (AMO) - the two largest companies in eye care products? Two-hundred and seventy-six patients will be randomly assigned to receive Alcon or AMO lenses for their cataract surgery at the Kensington Eye Institute (KEI). After surgery, patients will be instructed to return for follow-up visits at 1 month, 6 months, 12 months and 18 months to assess for the occurrence of glistenings. If glistenings are observed at an earlier follow-up visit (e.g., the 6 month visit), patients will still be instructed to come for future visits so that changes in the glistenings over time can be observed. Project Time-line: Months 1-8: Participants recruiting, surgical operations, follow-up visits. Months 9-24: follow-up visits, data entry, cleaning and analysis, early results presentation, manuscript preparation and final report.

Official Title
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The Incidence of Glistenings in the 2017 Generation of Hydrophobic Acrylic Lenses Manufactured by Alcon and Abbott Medical Optics

Conditions
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Cataracts, Visual Acuity Reduced Transiently, Loss of Visual Contrast Sensitivity, Functional Visual Loss

Intervention / Treatment
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* Device: Alcon 1 piece SA60AT lens
* Device: AMO 1-piece AABOO lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcon lens group<br>Alcon 1 piece SA60AT lens | Device: Alcon 1 piece SA60AT lens<br>* Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer<br>|
| Active Comparator: AMO lens group<br>AMO 1 piece Sensar AABOO lens | Device: AMO 1-piece AABOO lens<br>* Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract surgery, Intraocular lens, Glistenings