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

A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism

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.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Device: T-flex Aspheric Toric IOL; Device: AT TORBI toric IOL

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Phillip J Buckhurst, PhD; Phone Number: +44 (0) 1752 588884; Email: phillip.buckhurst@plymouth.ac.uk

Study Locations

• United Kingdom
  • Essex
    • Westcliff on Sea, Essex, United Kingdom, SS09AG
      • Recruiting
      • BMI Southend Private Hospital
      • Contact: Maralyn Cole; Phone Number: 01702 608908; Email: Maralyn.Cole@bmihealthcare.co.uk
      • Contact: Elizabeth Law, BSc(hons); Email: elizabeth.law@plymouth.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Best-corrected visual acuity	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

Outcome Measure	Time Frame
Manifest refraction	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	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	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	visit 4 (3-4 months)

Collaborators and Investigators

• Sponsor: University of Plymouth
• Collaborators: BMI Southend Hospital
• Investigators: Principal Investigator: Phillip J Buckhurst, PhD, Plymouth University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Lenses, Intraocular
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IISR-2014-003