NCT Number: NCT02903927
Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF.
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Conditions
Age range
50 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
- Senile cataract in at least 1 eye;
- Assured follow-up examinations;
- Healthy eyes besides clinically significant cataract
- Biometry measurement/cataract density compatible with the IOLMaster evaluation.
Post-operative inclusion criteria:
- IOL implanted in the capsular bag;
- The IOL model (CT LUCIA 601PY or Acrysof IQ SN60WF) has been implanted;
- No intraoperative complications; no damaged capsular bag, no intraocular hemorrhage; no can opener rhexis.
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;
- Current participation in another drug or device investigation;
- 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 the operated eye
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
- 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 follow-up
- Previous intraocular and corneal surgery
- Expected postop. astigmatism greater than 1 D
- Any type of corneal disorder
- Dementia
- Diabetes mellitus
- Pseudoexfoliation syndrome (PXF)
- 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
Treatment and study plan
Implantation of Acrysof IQ SN60WF IOL
DevicePrimary outcomes
-
Uncorrected distance visual acuity (UCVA) (monocular)
Time frame: 6 months
Sponsors and collaborators
Lead sponsor
Carl Zeiss Meditec AG
Industry
Registry information
Official study title
Prospective Comparative Randomized Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
Acronym: LUCIOL
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Sep 16, 2016
- Registry last updated
- Jan 29, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.