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A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses

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ClinicalTrials.gov Identifier: NCT02264457
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
BMI Southend Hospital
Information provided by (Responsible Party):
Dr Phillip J Buckhurst, University of Plymouth

Tracking Information
First Submitted Date  ICMJE October 8, 2014
First Posted Date  ICMJE October 15, 2014
Last Update Posted Date January 23, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
Best-corrected visual acuity [ Time Frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02264457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
  • Manifest refraction [ Time Frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months) ]
  • Rotational stability [ Time Frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months) ]
  • IOL centration [ Time Frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months) ]
  • Prevalence of posterior capsular Opacification [ Time Frame: visit 4 (3-4 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses
Official Title  ICMJE A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism
Brief Summary During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your eyes have astigmatism, which is a normal and common characteristic of the eye. If left uncorrected the astigmatism would mean that you would need to wear spectacles for viewing distance objects. New IOL designs called toric IOLs help to correct the astigmatism to improve your vision after cataract surgery. This study has been designed to look at how well a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing distance objects. There are many designs of these toric IOLs and for this study we are looking to compare two different designs of toric IOLs by putting one lens in your right eye and a different type of lens in your left eye. Both lenses are commercially available and are commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge the visual performance of these lenses and the ability of these lenses to correct astigmatism. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Device: T-flex Aspheric Toric IOL
  • Device: AT TORBI toric IOL
Study Arms  ICMJE
  • First eye closed loop haptic
    subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery
    Interventions:
    • Device: T-flex Aspheric Toric IOL
    • Device: AT TORBI toric IOL
  • First eye plate haptic
    subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery
    Interventions:
    • Device: T-flex Aspheric Toric IOL
    • Device: AT TORBI toric IOL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 50-75 years, bilateral significant corneal astigmatism >1.50D.
  • Requiring a Toric IOL within the following power range:
  • Sphere +6.00D to +30.00D
  • Cylinder +1.00D to +6.00D

Exclusion Criteria:

  • Amblyopia,
  • predicted bilateral post-op corneal astigmatism of <1.50D,
  • irregular astigmatism,
  • dilated pupil size smaller than 5mm,
  • macular pathology,
  • glaucoma,
  • retinal disease,
  • corneal disease,
  • abnormal iris,
  • pupil deformation and
  • any previous corneal or intraocular surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Phillip J Buckhurst, PhD +44 (0) 1752 588884 phillip.buckhurst@plymouth.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02264457
Other Study ID Numbers  ICMJE IISR-2014-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Phillip J Buckhurst, University of Plymouth
Study Sponsor  ICMJE University of Plymouth
Collaborators  ICMJE BMI Southend Hospital
Investigators  ICMJE
Principal Investigator: Phillip J Buckhurst, PhD Plymouth University
PRS Account University of Plymouth
Verification Date January 2019

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