Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision

NCT05506553 | Unknown DMC FDA Device

• 1 other identifier: 311123
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract; Presbyopia; Astigmatism

Keywords

Cataract; Presbyopia; Astigmatism

Outcome Measures

Primary Outcomes (13)

• 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

  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

Secondary Outcomes (9)

• 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

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Bilateral insertion of Alcon IQ Toric IOL in micro-monovision

Device: Control Arm - Alcon IQ Toric Intraocular lens

Intervention arm

EXPERIMENTAL

Bilateral insertion of Eyhance Toric II IOL

Device: Intervention arm - Eyhance Toric II Intraocular Lens

Interventions

Intervention arm - Eyhance Toric II Intraocular Lens DEVICE

Bilateral cataract extraction and insertion of Eyhance Toric II Intraocular Lens

Intervention arm

Control Arm - Alcon IQ Toric Intraocular lens DEVICE

Bilateral cataract extraction and insertion of Alcon IQ Toric Intraocular Lens

Also known as: Control Group

Control arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral cataract requiring surgical intervention,
• age over 18 years
• able to understand informed consent and the objectives of the trial,
• not pregnant, not breast feeding
• no previous intraocular eye surgery
• good visual potential in both eyes
• corneal astigmatism of 1.5 to 6 dioptres

You may not qualify if:

• Any patient with other ocular condition that might reduce visual acuity and hence confound the results such as:
• visually impairing age-related macular degeneration
• Advanced glaucoma
• previous retinal vascular disorders
• previous retinal detachment or tear
• any visually impairing neuro-ophthalmological condition
• any inherited retinal disorder or pathology
• previous strabismus surgery or record of amblyopia
• previous visually impairing CVA, TIA or other vaso-occlusive disease
• already enrolled in another study or trial
• instability of keratometry or biometry measurements
• irregular astigmatism
• previous significant trauma to eye

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• City, University of London: collaborator
• King's College London: collaborator

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Cataract; Presbyopia; Astigmatism

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• David O'Brart, MBBS, MD

  Guy's and St Thomas' NHS Foundation Trust

  STUDY DIRECTOR

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: SPONSOR

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: August 18, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)