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

Carl Zeiss Meditec

Status: Completed

Conditions: Cataract

Treatments: Device: AT LISA tri toric 939MP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02985723

2012-A01671-42

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

939MP

Experimental group

Description:

AT LISA tri toric 939MP intraocular lens

Treatment:

Device: AT LISA tri toric 939MP