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Clinical Trials/NCT02985723
NCT02985723
Completed
Not Applicable

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

Carl Zeiss Meditec AG0 sites120 target enrollmentMarch 2013
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ConditionsCataract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Carl Zeiss Meditec AG
Enrollment
120
Primary Endpoint
Best distance-corrected visual acuity for intermediate vision after bilateral implantation
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
June 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Best distance-corrected visual acuity for intermediate vision after bilateral implantation

Time Frame: 12 months after surgery

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