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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03409185
Other study ID # 108162330RR0001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 11, 2017
Est. completion date March 31, 2023

Study information

Verified date December 2023
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Alcon 1 piece SA60AT lens
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer
AMO 1-piece AABOO lens
Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic

Locations

Country Name City State
Canada Kensington Eye Institute Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto Kensington Eye Institute

Country where clinical trial is conducted

Canada, 

Outcome

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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