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

Study Overview
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: T-flex Aspheric Toric IOL
* Device: AT TORBI toric IOL


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: First eye closed loop haptic<br>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<br> <br> Device: AT TORBI toric IOL<br> <br> |
| Other: First eye plate haptic<br>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<br> <br> Device: AT TORBI toric IOL<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenses, Intraocular