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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

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.

Condition or disease Intervention/treatment Phase
Cataract Device: T-flex Aspheric Toric IOL Device: AT TORBI toric IOL Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism
Study Start Date : June 2015
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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
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
Device: T-flex Aspheric Toric IOL
Device: AT TORBI toric IOL



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. Prevalence of posterior capsular Opacification [ Time Frame: visit 4 (3-4 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264457


Contacts
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Contact: Phillip J Buckhurst, PhD +44 (0) 1752 588884 phillip.buckhurst@plymouth.ac.uk

Locations
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United Kingdom
BMI Southend Private Hospital Recruiting
Westcliff on Sea, Essex, United Kingdom, SS09AG
Contact: Maralyn Cole    01702 608908    Maralyn.Cole@bmihealthcare.co.uk   
Contact: Elizabeth Law, BSc(hons)       elizabeth.law@plymouth.ac.uk   
Sponsors and Collaborators
University of Plymouth
BMI Southend Hospital
Investigators
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Principal Investigator: Phillip J Buckhurst, PhD Plymouth University

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Responsible Party: Dr Phillip J Buckhurst, Associate Professor (Senior Lecturer), University of Plymouth
ClinicalTrials.gov Identifier: NCT02264457     History of Changes
Other Study ID Numbers: IISR-2014-003
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Dr Phillip J Buckhurst, University of Plymouth:
Lenses, Intraocular
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases