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A Randomised, Controlled Study to Compare Visual Performance Following Bilateral, Micro-monovision Insertion of Two Toric, Aspheric, Hydrophobic Acrylic Intraocular Lenses: The TECNIS Eyhance Toric II IOL and the Alcon Acrysof IQ Toric IOL
Sponsor study identifier
interventional
140
1 country
1
Study Start
September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In an aging population, cataract and presbyopia become increasingly common. A cataract is the opacification of the natural crystalline lens inside a person's eye, causing reduction of vision. Presbyopia is an age related condition resulting in loss of reading/near vision which results in requiring reading glasses. Astigmatism is a common condition characterized by an abnormal cornea (the clear tissue at the front of the eye) which results in blurred distance and near vision, again requiring glasses. Cataract surgery is the most common elective surgery worldwide for patients over 65. It is composed of removal the cataract and insertion of a new intraocular lens (IOL). Currently only monofocal IOLs are available on the National Health Service (United Kingdom) - meaning they give good distance or near vision. The majority of patients opt for good distance vision with glasses to read. The investigators are trialling insertion of a new Extended Depth of Focus (enhanced aspheric) Toric IOL (EDoF Toric IOL), which treats all 3 conditions - cataract, presbyopia and astigmatism. All patients attending St Thomas' hospital for treatment of cataracts, who have presbyopia and astigmatism will be considered for invitation to the study. Patients who participate in the study will be randomly selected to receive either the new IOL - the TECNIS Eyhance Toric II IOL, or a well-established IOL the Alcon Acrysof IQ Toric IOL during cataract surgery. Insertion of the Alcon Acrysof IQ Toric IOL is known to treat cataract and astigmatism but not presbyopia. Patients will be assessed and have their surgery performed at St Thomas' Hospital London. They will have 7 appointments over 12 months, plus surgery. The investigators hope to demonstrate better distance, intermediate and near vision and increased spectacle independence in the TECNIS Eyhance Toric II IOL group. EDoF Toric IOLs have the potential to transform cataract surgery outcomes for patients in the NHS.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 14, 2022
Actual (reported)August 18, 2022
Actual (reported)September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in Refractive Error from baseline to 6 weeks
Optometrist assessed refractive error for Near, and distance vision
6 weeks after cataract surgery
Change in Refractive Error from baseline to 6 months
Optometrist assessed refractive error for Near, and distance vision
6 months after cataract surgery
Change in Visual acuity from baseline to 6 weeks
Uniocular - unaided and best corrected near, intermediate and distance vision Binocular - unaided and best corrected near, intermediate and distance vision
6 weeks after each cataract surgery
Change in Visual acuity from baseline to 6 months
Uniocular - unaided and best corrected near, intermediate and distance vision Binocular - unaided and best corrected near, intermediate and distance vision
Change in Stereoacuity at 6 weeks after second eye surgery
6 weeks after second cataract surgery
Change in Stereoacuity at 6 months after second eye surgery
6 months after second cataract surgery
Change in Contrast sensitivity at 6 weeks after cataract surgery
6 weeks after each cataract surgery
Change in Contrast sensitivity at 6 months after cataract surgery
6 months after each cataract surgery
Post-operative complications 2 weeks after surgery
2 weeks after each cataract surgery
Bilateral insertion of Alcon IQ Toric IOL in micro-monovision
Bilateral insertion of Eyhance Toric II IOL
Bilateral cataract extraction and insertion of Eyhance Toric II Intraocular Lens
Bilateral cataract extraction and insertion of Alcon IQ Toric Intraocular Lens
St Thomas' Hospital
London, SE1 7EH, United Kingdom
David O'Brart, MBBS, MD
Guy's and St Thomas' NHS Foundation Trust
First Submitted
July 14, 2022
First Posted
August 18, 2022
Study Start
September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
6 months after each cataract surgery
Change in Patient Satisfaction from baseline to 6 weeks
Patient satisfaction - PROM questionnaire EQ-5D-3L
6 weeks after each cataract surgery
Change in Patient Satisfaction from baseline to 6 weeks
Patient satisfaction - PROM questionnaire Catquest-9SF
6 weeks after each cataract surgery
Change in Patient Satisfaction from baseline to 6 weeks
Patient satisfaction - PROM questionnaire Cat-PROM
6 weeks after each cataract surgery
Change in Patient Satisfaction from baseline to 6 months
Patient satisfaction - PROM questionnaire EQ-5D-3L
6 months after each cataract surgery
Change in Patient Satisfaction from baseline to 6 months
Patient satisfaction - PROM questionnaire Catquest-9SF
6 months after each cataract surgery
Change in Patient Satisfaction from baseline to 6 months
Patient satisfaction - PROM questionnaire Cat-PROM
6 months after each cataract surgery
Change in rotational stability of Intraocular lens relative to its intended angle of insertion from baseline to 6 weeks
IOL rotation judged using colour photography
6 weeks after each cataract surgery
Change in rotational stability of Intraocular lens relative to its intended angle of insertion from baseline to 6 months
IOL rotation judged using colour photography
6 months after each cataract surgery
Patient related cost benefits in terms of spectacle expenditure.
Cost of spectacles purchased after cataract surgery will be compared between the two group
6 months after second eye cataract surgery
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September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 18, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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