Visual Outcome, Cylinder Correction and Patient Satisfact... | NCT02985723

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

NCT02985723

Sponsor

Carl Zeiss Meditec AG

Status

Completed

Last Update Posted

Jan 29, 2018Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

AT LISA tri toric 939MP

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Dec 5, 2016

First Submission Date that Met QC Criteria

Dec 5, 2016

First Posted Date

Dec 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2018

Last Update Posted Date

Jan 29, 2018Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Label	Type	Description	Intervention Names
939MP	Experimental	AT LISA tri toric 939MP intraocular lens	Device: AT LISA tri toric 939MP

Name	Type	Description	Arm Group Labels	Other Names
AT LISA tri toric 939MP	Device		939MP

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

Eligibility Module

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases