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Comparison of Two Aspheric Intraocular Lenses for Micro-monovision

NCT05531110 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-09-07

No results posted yet for this study

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

Interventions

DEVICE

Cataract surgery with insertion of Eyhance ICB00

Cataract surgery with insertion of Eyhance ICB00

DEVICE

Cataract surgery with insertion of Alcon SN60WF

Cataract surgery with insertion of Alcon SN60WF

Sponsors & Collaborators

  • City, University of London

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • David O'Brart, MBBS, MD · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2024-08-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531110 on ClinicalTrials.gov