Comparison of Two Aspheric Intraocular Lenses for Micro-monovision

NCT05531110 | Unknown FDA Device

• 1 other identifier: 315330
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In an aging population, cataract and presbyopia become increasingly common. A cataract develops when the natural crystalline lens inside a person's eye, becomes cloudy over time, causing reduction of vision. Presbyopia is an age related condition resulting in loss of reading/near vision and requiring reading glasses. Cataract surgery is the most common elective surgery in the world 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 NHS (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) IOL (EDoF IOL), which treats both cataract and presbyopia. All patients attending St Thomas' hospital for treatment of cataracts will be considered for invitation to the study. Patients who participate in the study will be randomly selected to receive either the new Extended Depth of Focus IOL - the TECNIS Eyhance ICB00 IOL, or a well-established monofocal (non-EDoF) IOL the Alcon Acrysof IQ SN60WF IOL during cataract surgery. Insertion of the Alcon Acrysof IQ SN60WF IOL is known to treat cataract 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 ICB00 IOL group. EDoF IOLs have the potential to improve cataract surgery outcomes for patients in the NHS.

Conditions

Cataract; Presbyopia; Pseudophakia

Keywords

cataract; pseudophakia; presbyopia

Outcome Measures

Primary Outcomes (12)

• Change in Visual Acuity from baseline to 6 weeks

  Uniocular \& Binocular, Unaided and Best Corrected, Near, intermediate and distance vision

  6 weeks after cataract surgery

• Change in Visual Acuity from baseline to 6 months

  Uniocular \& Binocular, Unaided and Best Corrected, Near, intermediate and distance vision

  6 months after cataract surgery

• 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 Patient Satisfaction from baseline to 6 weeks

  Patient satisfaction - PROM questionnaire: EQ-5D-3L scores A 2 part questionnaire 1. 5 questions, with 3 options each. Each question is scored 1 to 3, with the cumulative assessment described as a 5 digit code. 2. The second part asks patients to estimate their health on the day of the questionnaire on a numerical and visual scale ranging from 0 (worst health possible) to 100 (best health imaginable).

  baseline and 6 weeks after cataract surgery

• Change in Patient Satisfaction from baseline to 6 weeks

  patient satisfaction - PROM questionnaire: Catquest-9SF scores 9 item questionnaire with 4 options each, can be converted to a numerical score (9-36), with 36 being the worst vision

  baseline and 6 weeks after cataract surgery

• Change in Patient Satisfaction from baseline to 6 weeks

  patient satisfaction - PROM questionnaire: Cat-PROM scores 5 question questionnaire which gives a converted Rasch score, from 0-100, with 100 the best vision

  baseline and 6 weeks after cataract surgery

• Change in Patient Satisfaction from baseline to 6 months

  patient satisfaction - PROM questionnaire: EQ-5D-3L scores A 2 part questionnaire 1. 5 questions, with 3 options each. Each question is scored 1 to 3, with the cumulative assessment described as a 5 digit code. 2. The second part asks patients to estimate their health on the day of the questionnaire on a numerical and visual scale ranging from 0 (worst health possible) to 100 (best health imaginable).

  baseline and 6 months after cataract surgery

• Change in Patient Satisfaction from baseline to 6 months

  Patient satisfaction - PROM questionnaire: Catquest-9SF scores 9 item questionnaire with 4 options each, can be converted to a numerical score (9-36), with 36 being the worst vision

  baseline and 6 months after cataract surgery

• Change in Patient Satisfaction from baseline to 6 months

  PROM questionnaire : Cat-PROM scores 5 question questionnaire which gives a converted Rasch score, from 0-100, with 100 the best vision

  baseline and 6 months after cataract surgery

• Change in Cost Benefits from baseline to 6 weeks

  Patient related cost benefits in terms of spectacle expenditure.

  6 weeks after cataract surgery

• Change in Cost Benefits from baseline to 6 months

  Patient related cost benefits in terms of spectacle expenditure.

  6 months after cataract surgery

Secondary Outcomes (7)

• Change in Contrast Sensitivity at 6 weeks after surgery

  6 weeks after cataract surgery

• Change in Contrast Sensitivity at 6 months after surgery

  6 months after cataract surgery

• Change in Stereoacuity at 6 weeks after cataract surgery

  6 weeks after the second cataract surgery

• Change in Stereoacuity at 6 months after cataract surgery

  6 months after the second cataract surgery

• Documentation of Post-operative complications 2 weeks after surgery

  2 weeks after cataract surgery

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Bilateral Alcon SN60WF IOL insertion

Device: Cataract surgery with insertion of Alcon SN60WF

Intervention arm

EXPERIMENTAL

Bilateral Eyhance ICB00 IOL

Device: Cataract surgery with insertion of Eyhance ICB00

Interventions

Cataract surgery with insertion of Eyhance ICB00 DEVICE

Cataract surgery with insertion of Eyhance ICB00

Intervention arm

Cataract surgery with insertion of Alcon SN60WF DEVICE

Cataract surgery with insertion of Alcon SN60WF

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 less than 1.5 diopters

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
• age over 100

Sponsors & Collaborators

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

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Cataract; Presbyopia; Pseudophakia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• David O'Brart, MBBS, MD

  Guy's and St Thomas' NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Ashmal A Jameel, MBBS, BSc

CONTACT

+447739020782; ashmal.jameel@gstt.nhs.uk

Scott Robbie, MBBS, PhD

CONTACT

scott.robbie@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will not be informed of which arm of the study they will be allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 7, 2022
• Study Start: October 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)