To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses (VENUStoric)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CZM IOL
Competitor IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent
- Patients of any gender, aged 18 or older
- Assured follow-up examinations
- Healthy eyes with clinically significant age related cataract requiring surgical treatment
- Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment
- Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement)
8. Cataract density compatible with biometry measurement
Exclusion Criteria:
- Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
- Patients whose freedom is impaired by administrative or legal order
- Current participation in another drug or device investigation that affects patients vision
- Ocular disorders, other than cataract, that could potentially cause future acuity loss
- Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
- Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
- History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis
- Pseudoexfoliation syndrome (according to investigator decision)
- Pathologic miosis or Pharmacotherapy with miotic agent
- Irregular astigmatism / Keratoconus
- Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
- All kind of infections (acute ocular disease, external / internal infection, systemic infection)
- Traumatic cataract
- Monophthalmic patient
- Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
- Patient expected to require retinal laser treatment before the end of the last follow-up examination
- Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination
- Previous intraocular and corneal / refractive surgery
- Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision)
- Dementia
- Previous use of cytotoxic drugs or total body irradiation within last 2 years
- Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
- Pregnancy and / or lactation period
Sites / Locations
- Universitätsklinikum Freiburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CZM IOL
Competitor IOL
Arm Description
Outcomes
Primary Outcome Measures
IOL axis
IOL axis will be analyzed based on images.
Secondary Outcome Measures
Full Information
NCT ID
NCT03839420
First Posted
February 1, 2019
Last Updated
February 7, 2023
Sponsor
Carl Zeiss Meditec AG
1. Study Identification
Unique Protocol Identification Number
NCT03839420
Brief Title
To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses
Acronym
VENUStoric
Official Title
Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
October 4, 2020 (Actual)
Study Completion Date
February 17, 2021 (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
To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparative randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CZM IOL
Arm Type
Experimental
Arm Title
Competitor IOL
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CZM IOL
Intervention Description
implantation of CZM IOL
Intervention Type
Device
Intervention Name(s)
Competitor IOL
Intervention Description
implantation of Competitor IOL
Primary Outcome Measure Information:
Title
IOL axis
Description
IOL axis will be analyzed based on images.
Time Frame
Immediately after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent
Patients of any gender, aged 18 or older
Assured follow-up examinations
Healthy eyes with clinically significant age related cataract requiring surgical treatment
Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment
Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement)
8. Cataract density compatible with biometry measurement
Exclusion Criteria:
Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
Patients whose freedom is impaired by administrative or legal order
Current participation in another drug or device investigation that affects patients vision
Ocular disorders, other than cataract, that could potentially cause future acuity loss
Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis
Pseudoexfoliation syndrome (according to investigator decision)
Pathologic miosis or Pharmacotherapy with miotic agent
Irregular astigmatism / Keratoconus
Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
All kind of infections (acute ocular disease, external / internal infection, systemic infection)
Traumatic cataract
Monophthalmic patient
Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
Patient expected to require retinal laser treatment before the end of the last follow-up examination
Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination
Previous intraocular and corneal / refractive surgery
Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision)
Dementia
Previous use of cytotoxic drugs or total body irradiation within last 2 years
Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
Pregnancy and / or lactation period
Facility Information:
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses
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