A Trial of Toric Versus Non-toric Intraocular Lenses in Phacoemulsification Cataract Surgery

October 22, 2012 updated by: Mr Masoud Teimory, Western Sussex Hospitals NHS Trust

This is a randomised controlled trial that formally compares intra-ocular lenses, which can be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is the newer toric lens which can correct astgimatism.

The null hypothesis is that both intra-ocular lenses give the same visual outcome in cataract surgery. The alternative hypothesis is that the toric lens, provides a better unaided (without glasses) vision, by correcting the participant's astigmatism.

It has been decided to conduct a randomised controlled trial of the two lenses, as although the toric lenses are endorsed by many case series (which show a reduction in astigmatism), they have not been formally compared to the standard lens. An RCT will enable the formal comparison.

It is expected that this trial will take approximately a year to conduct: six months of recruitment and six months of follow-up. A further six months will be required to analyse the data and prepare a manuscript for publication.

The investigators do not plan to conduct an interim analysis or report as this is a short-trial (six months follow-up) using two alternative lens that are CE marked and already widely used.

Participants who have both cataract and astigmatism will be identified from the GP/optometrist referral letter. They will be seen in specially designated clinics for this research study, which will run alongside the routine cataract 'one' stop clinics at St Richard's Hospital and Worthing Hospital. This will allow for those patients who wish to be part of the study to have all the necessary examination done in one visit and for those who decline participation to be seen in the regular cataract clinic. Potential participants will be sent the research trial information (appendix A) with their appointment letter.

After introducing himself the researcher (who is also a senior cataract surgeon at Western Sussex Hospital Trust), will check if potential participants have had the opportunity to read the trial information that they were sent, or give participants a further copy as required. The key points of the trial will be re-iterated by the researcher and they will be invited to ask any questions about the trialThe researcher will check that the potential participant has read and understood the participant information leaflet. They will answer any questions that the potential participant has and will then take signed consent from those willing to participate.

Only one eye (the 'trial eye') from each patient will be used in the trial. In patients with bilateral cataract, one eye will be selected as the trial eye. This will be the eye that the participant prefers, after consultation with the researcher or surgeon, to have operated first. The participant will be allocated a unique study reference number.

Patients who decline to take part in the trial will be offered cataract surgery as per usual WSHT/NHS procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Sussex
      • Worthing and Chichester, West Sussex, United Kingdom
        • Western Sussex Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Symptomatic cataract for which the patient desires surgery
  2. Corneal astigmatism of greater than or equal to 2 dioptres
  3. No significant ophthalmic comorbidity

Exclusion criteria

  1. <18 years of age
  2. Significant ophthalmic co-morbidity
  3. Pregnant
  4. Medically unfit for cataract surgery
  5. Not competent to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toric intraocular lens
TFlex Lens (623T)
Device: Phacoemulsfication cataract surgery and intra-ocular lens implant
Placebo Comparator: Monofocal intraocular lens
Superflex Aspheric Lens (920H)/Cflex Aspheric Lens (970C)
Device: Phacoemulsfication cataract surgery and intra-ocular lens implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Unaided LogMAR visual acuity at 2 months post-operatively

Secondary Outcome Measures

Outcome Measure
Unaided LogMAR visual acuity at 2 weeks and 6 months post-operatively
Corrected visual acuity at 2 months and 6 months post-operatively
Residual spherical and cylindrical prescriptions at 2 weeks, 2 months and 6 months post-operatively
Patients quality of life questionnaire to assess subjective vision, glare at day/night, subjective colour perception, other symptoms.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Sussex Hospitals NHS Trust

Collaborators

Rayner Intraocular Lenses Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 23, 2012

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1518/WSHT/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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