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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type OTHER

T-flex Aspheric Toric IOL

Intervention Type DEVICE

AT TORBI toric IOL

Intervention Type DEVICE

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

Group Type OTHER

T-flex Aspheric Toric IOL

Intervention Type DEVICE

AT TORBI toric IOL

Intervention Type DEVICE

Interventions

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T-flex Aspheric Toric IOL

Intervention Type DEVICE

AT TORBI toric IOL

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No