Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the postoperative visual acuity for distance, intermediate and near vision as well as the cylinder correction and the patient satisfaction after bilateral implantation of AT LISA tri toric 939MP IOLs.

Official Title
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Prospective Study to Evaluate the Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses

Conditions
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Cataract

Intervention / Treatment
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* Device: AT LISA tri toric 939MP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent Man or woman, over 50 years of age Healthy eyes with bilateral cataract requiring surgical treatment for both eyes Bilateral regular corneal astigmatism (confirmed by topography measurement) Only patients requiring intraocular lenses of a power comprised between sphere +0.0 and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will be able to participate in the trial. Biometry measurement/cataract density compatible with the IOLMaster evaluation Bilateral uncomplicated cataract surgery and implantation into capsular bag by injector Assured follow-up examinations Exclusion Criteria: Patients unable to meet the limitations of the protocol or likely of non cooperation during the trial, Patients whose freedom is impaired by administrative or legal order, Monophtalmic patient. Previous ocular surgery, including corneal/refractive surgery, Chronic or recurrent uveitis, Acute ocular disease or external/internal infection, Any kind of macular degeneration and impairment of retina (clinical diagnosis/OCT examination) Diabetes with retinal changes, Pseudoexfoliation syndrome Pathologic myosis Irregular astigmatism, especially keratoconus, Endothelial corneal dystrophy Glaucoma or IOP higher than 21mmHg under ocular hypertension treatment Aniridia Pseudophakia Cornea guttata; keratoplasty Amotio operation; anamnesis with vitreous surgery Amblyopia Intraocular tumours; endotamponade Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient Pupil diameter over 6 mm in mesopic condition Corneal opacity

Ages Eligible for Study
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Minimum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 939MP<br>AT LISA tri toric 939MP intraocular lens | Device: AT LISA tri toric 939MP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best distance-corrected visual acuity for intermediate vision after bilateral implantation |  | 12 months after surgery |