NCT02264457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

4.5 years

First QC Date

October 8, 2014

Last Update Submit

January 22, 2019

Conditions

Cataract

Keywords

Lenses, Intraocular

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

Study Arms (2)

First eye closed loop haptic

OTHER

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 IOLDevice: AT TORBI toric IOL

First eye plate haptic

OTHER

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 IOLDevice: AT TORBI toric IOL

Interventions

T-flex Aspheric Toric IOLDEVICE
First eye closed loop hapticFirst eye plate haptic
AT TORBI toric IOLDEVICE
First eye closed loop hapticFirst eye plate haptic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMI Southend Private Hospital

Westcliff-on-Sea, Essex, SS09AG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Phillip J Buckhurst, PhD

    Plymouth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip J Buckhurst, PhD

CONTACT

+44 (0) 1752 588884phillip.buckhurst@plymouth.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Senior Lecturer)

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 15, 2014

Study Start

June 1, 2015

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

GB(1)