To Compare Postoperative Horizontal Position Stability of... | NCT04036149

Studies
To Compare Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP

NCT04036149

Sponsor

Carl Zeiss Meditec AG

Status

Completed

Last Update Posted

Jul 31, 2019Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Cataract Senile

Interventions

Intraocular lens

Countries

Austria

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

Jul 2019

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 14, 2017Actual

Primary Completion Date

Jul 20, 2018Actual

Completion Date

Jul 20, 2018Actual

First Submitted Date

Jul 26, 2019

First Submission Date that Met QC Criteria

Jul 26, 2019

First Posted Date

Jul 29, 2019Actual

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

Jul 29, 2019

Last Update Posted Date

Jul 31, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective of the trial is to assess the efficacy of the CT LUCIA 611P intraocular lens (IOL) with regard to the horizontal IOL position stability. The horizontal position collected at 1 month and 4 to 6 months post-operatively will be compared to the horizontal IOL position recorded at baseline (1 week post-operatively) as well as to the position stability of the reference IOL, CT ASPHINA 409MP.

Detailed Description

Not provided

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

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LUCIA	Experimental	CT LUCIA 611P - Intraocular lens	Device: Intraocular lens
ASPHINA	Active Comparator	CT ASPHINA 409MP - Intraocular lens	Device: Intraocular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraocular lens	Device	Implantation as part of cataract surgery	ASPHINA LUCIA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Horizontal position stability	Evaluation of the horizontal position stability of the CT LUCIA 611P IOL. The horizontal position at M1 and M4-6 will be compared to the horizontal IOL position at baseline (W1) and to the position stability of the reference IOL, CT ASPHINA 409MP.	1 week to 4-6 months post-operatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

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;
Patients of any gender, aged 50 to 90 years;
Assured follow-up examinations;
Healthy eyes besides clinically significant bilateral age-related cataract.
Distance corrected visual acuity ≤ 0.3 logMAR Normal findings in the medical history and physical examination
Calculated IOL power within the available dioptre range;
Biometry measurement/cataract density compatible with the IOLMaster evaluation.

Per operative inclusion criteria:

IOL implanted in the capsular bag;
The 2 IOL models (CT LUCIA 611P and CT ASPHINA 409MP) have been implanted in the 2 eyes of one patient;
No intraoperative complications; no damaged capsular bag, no intraocular haemorrhage; no can opener rhexis.

Exclusion Criteria:

Allergy to heparin
Monophthalmic patient
Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse in either eye;
Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.);
Floppy iris syndrome;
Diabetic retinopathy;
Traumatic cataract;
Aniridia;
Microphthalmus;
Amblyopia;
Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders);
Patient expected to require retinal laser treatment before the end of the last follow-up;
Previous intraocular and corneal surgery;
Expected postop. astigmatism greater than 1 D;
Any type of corneal disorder;
Dementia;
Pseudoexfoliation syndrome (PEX);
Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient.
Pregnancy and/or lactation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies
D019736	Prostheses and Implants