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CompletedNCT02985723VICTORIUpdated Jan 29, 2018

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

An interventional study of AT LISA tri toric 939MP in Cataract, sponsored by Carl Zeiss Meditec AG. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-01-29.

Sponsored by Carl Zeiss Meditec AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

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Lead sponsor

Carl Zeiss Meditec AG is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    939MP

    AT LISA tri toric 939MP intraocular lens

    Device: AT LISA tri toric 939MP

Interventions

  • DeviceAT LISA tri toric 939MP
06

What researchers measure

Primary outcomes

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

    Time frame: 12 months after surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02985723
Lead sponsor
Carl Zeiss Meditec AG
Responsible party
Sponsor
First posted
Dec 7, 2016
Start date
Mar 2013
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jan 29, 2018

Study contacts

Piovella, Dr
principal investigator · CMA - Centro Microchirurgia Ambulatoriale
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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