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

January 25, 2018 updated by: Carl Zeiss Meditec AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 939MP
AT LISA tri toric 939MP intraocular lens
Device: AT LISA tri toric 939MP

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl Zeiss Meditec AG

Investigators

  • Principal Investigator: Piovella, Dr, CMA - Centro Microchirurgia Ambulatoriale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01671-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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