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

Primary Purpose

Cataract Senile

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Intraocular lens
Sponsored by
Carl Zeiss Meditec AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Senile

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VIROS, Hanusch Hospital, Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LUCIA

ASPHINA

Arm Description

CT LUCIA 611P - Intraocular lens

CT ASPHINA 409MP - Intraocular lens

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2019
Last Updated
July 29, 2019
Sponsor
Carl Zeiss Meditec AG
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1. Study Identification

Unique Protocol Identification Number
NCT04036149
Brief Title
To Compare Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
Official Title
Prospective Clinical Trial to Compare the Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carl Zeiss Meditec AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LUCIA
Arm Type
Experimental
Arm Description
CT LUCIA 611P - Intraocular lens
Arm Title
ASPHINA
Arm Type
Active Comparator
Arm Description
CT ASPHINA 409MP - Intraocular lens
Intervention Type
Device
Intervention Name(s)
Intraocular lens
Intervention Description
Implantation as part of cataract surgery
Primary Outcome Measure Information:
Title
Horizontal position stability
Description
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.
Time Frame
1 week to 4-6 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
VIROS, Hanusch Hospital, Department of Ophthalmology
City
Vienna
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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