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Completed

NCT Number: NCT02985723

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT LISA tri toric 939MP

Device

Primary outcomes

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

    Time frame: 12 months after surgery

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

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

Acronym: VICTORI

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2016
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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