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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Mr Masoud Teimory, Western Sussex Hospitals NHS Trust.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712503
First Posted: October 23, 2012
Last Update Posted: October 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rayner Intraocular Lenses Ltd
Information provided by (Responsible Party):
Mr Masoud Teimory, Western Sussex Hospitals NHS Trust
October 19, 2012
October 23, 2012
October 23, 2012
January 2013
January 2014   (Final data collection date for primary outcome measure)
Unaided LogMAR visual acuity at 2 months post-operatively
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
A Trial of Toric Versus Non-toric Intraocular Lenses in Phacoemulsification Cataract Surgery
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cataract
  • Astigmatism
Device: Phacoemulsfication cataract surgery and intra-ocular lens implant
  • Experimental: Toric intraocular lens
    TFlex Lens (623T)
    Intervention: Device: Phacoemulsfication cataract surgery and intra-ocular lens implant
  • Placebo Comparator: Monofocal intraocular lens
    Superflex Aspheric Lens (920H)/Cflex Aspheric Lens (970C)
    Intervention: Device: Phacoemulsfication cataract surgery and intra-ocular lens implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
190
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01712503
1518/WSHT/2012
No
Not Provided
Not Provided
Mr Masoud Teimory, Western Sussex Hospitals NHS Trust
Western Sussex Hospitals NHS Trust
Rayner Intraocular Lenses Ltd
Not Provided
Western Sussex Hospitals NHS Trust
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP