Trial record 5 of 26 for:    Open Studies | "Astigmatism"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Western Sussex Hospitals NHS Trust
Sponsor:
Collaborator:
Rayner Intraocular Lenses Ltd
Information provided by (Responsible Party):
Mr Masoud Teimory, Western Sussex Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01712503
First received: October 19, 2012
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Cataract
Astigmatism
Device: Phacoemulsfication cataract surgery and intra-ocular lens implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Western Sussex Hospitals NHS Trust:

Primary Outcome Measures:
  • Unaided LogMAR visual acuity at 2 months post-operatively

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 190
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712503

Contacts
Contact: Masoud Teimory masoud.teimory@wsht.nhs.uk
Contact: Saul Rajak saul.rajak@lshtm.ac.uk

Locations
United Kingdom
Western Sussex Hospital Trust Not yet recruiting
Worthing and Chichester, West Sussex, United Kingdom
Contact: Masoud Teimory       masoud.teimory@wsht.nhs.uk   
Contact: Saul Rajak       saul.rajak@lshtm.ac.uk   
Principal Investigator: Masoud Teimory         
Sub-Investigator: Pari Shah         
Sponsors and Collaborators
Western Sussex Hospitals NHS Trust
Rayner Intraocular Lenses Ltd
  More Information

No publications provided

Responsible Party: Mr Masoud Teimory, Consultant ophthalmologist and principle investigator, Western Sussex Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01712503     History of Changes
Other Study ID Numbers: 1518/WSHT/2012
Study First Received: October 19, 2012
Last Updated: October 22, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Western Sussex Hospitals NHS Trust:
Cataract
Astigmatism
Toric
Phacoemulsification
Intraocular lens

Additional relevant MeSH terms:
Astigmatism
Cataract
Refractive Errors
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on July 10, 2014