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

Cataract Clinical Trial

— VICTORI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985723
• Other study ID #: 2012-A01671-42
• Status: Completed
• Phase: N/A
• First received: December 5, 2016
• Last updated: January 25, 2018
• Start date: March 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2018
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AT LISA tri toric 939MP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best distance-corrected visual acuity for intermediate vision after bilateral implantation		12 months after surgery