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

Primary Purpose

Cataract

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
T-flex Aspheric Toric IOL
AT TORBI toric IOL
Sponsored by
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Lenses, Intraocular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • BMI Southend Private HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

First eye closed loop haptic

First eye plate haptic

Arm Description

subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery

subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery

Outcomes

Primary Outcome Measures

Best-corrected visual acuity

Secondary Outcome Measures

Manifest refraction
Rotational stability
IOL centration
Prevalence of posterior capsular Opacification

Full Information

First Posted
October 8, 2014
Last Updated
January 22, 2019
Sponsor
University of Plymouth
Collaborators
BMI Southend Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02264457
Brief Title
A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses
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 Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth
Collaborators
BMI Southend Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Lenses, Intraocular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
First eye closed loop haptic
Arm Type
Other
Arm Description
subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery
Arm Title
First eye plate haptic
Arm Type
Other
Arm Description
subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery
Intervention Type
Device
Intervention Name(s)
T-flex Aspheric Toric IOL
Intervention Type
Device
Intervention Name(s)
AT TORBI toric IOL
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)
Title
Prevalence of posterior capsular Opacification
Time Frame
visit 4 (3-4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phillip J Buckhurst, PhD
Phone
+44 (0) 1752 588884
Email
phillip.buckhurst@plymouth.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip J Buckhurst, PhD
Organizational Affiliation
Plymouth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
BMI Southend Private Hospital
City
Westcliff on Sea
State/Province
Essex
ZIP/Postal Code
SS09AG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maralyn Cole
Phone
01702 608908
Email
Maralyn.Cole@bmihealthcare.co.uk
First Name & Middle Initial & Last Name & Degree
Elizabeth Law, BSc(hons)
Email
elizabeth.law@plymouth.ac.uk

12. IPD Sharing Statement

Learn more about this trial

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

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