NCT03409185

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

5.7 years

First QC Date

December 18, 2017

Last Update Submit

December 1, 2023

Conditions

CataractsVisual Acuity Reduced TransientlyLoss of Visual Contrast SensitivityFunctional Visual Loss

Keywords

Cataract surgeryIntraocular lensGlistenings

Outcome Measures

Primary Outcomes (1)

  • 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 1. Less than 10 glistenings 2. 10 to 25 glistenings 3. 25 to 50 glistenings 4. 50 to 100 glistenings 5. Greater than 100 glistenings

    18-month follow-up

Secondary Outcomes (11)

  • Visual acuity in eyes with glistenings at 18-month follow-up visit

    18 month follow-up

  • Contrast sensitivity in eyes with glistenings at 18-month follow-up visit

    18 month follow-up

  • Glare disability in eyes with glistenings at 18-month follow-up visit

    18 month follow-up

  • Visual acuity in eyes with glistenings at 12-month follow-up visit

    12-month follow-up

  • Contrast sensitivity and glare disability in eyes with glistenings at 12-month follow-up visit

    12-month follow-up

  • +6 more secondary outcomes

Study Arms (2)

Alcon lens group

EXPERIMENTAL

Alcon 1 piece SA60AT lens

Device: Alcon 1 piece SA60AT lens

AMO lens group

ACTIVE COMPARATOR

AMO 1 piece Sensar AABOO lens

Device: AMO 1-piece AABOO lens

Interventions

Alcon 1 piece SA60AT lensDEVICE

Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer

Alcon lens group
AMO 1-piece AABOO lensDEVICE

Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic

AMO lens group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kensington Eye Institute

Toronto, Ontario, M5T3A9, Canada

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Sherif El-Defrawy, MD, FRCSC

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Yaping Jin, MD, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Ophthalmic Epidemiology

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 24, 2018

Study Start

July 11, 2017

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

CA(1)