Phase
Condition
Eye Disorders/infections
Eye Disease
Vision Loss
Treatment
EDF
Monofocal IOL
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients of any gender, aged 18 years or older
Patient with clinically significant bilateral age-related cataracts planned forphacoemulsification cataract extraction and eligible for implantation of a posteriorchamber intraocular lens as determined by investigator's medical judgement
Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)
Calculated lens power within the available range
Clear intraocular media other than cataract
Patient is willing and capable of providing informed consent
Patient is willing and capable of complying with visits and procedures as defined bythis protocol
Exclusion
Exclusion Criteria:
Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5decimal)
Endothelial cell count of less than 2000/mm2
Acute, chronic, or uncontrolled systemic disease that could increase the operativerisk or confound the outcome including but not limited to poorly controlled diabetesmellitus, active cancer treatment, mental illness, dementia, immunocompromised,connective tissue disease, clinically significant atopic disease, etc.
Ocular condition that may predispose patient to future complications, perinvestigator's medical judgement, including but not limited to severe dry eye,anterior segment pathology, uncontrolled glaucoma, that would result in a visualacuity of 0.2 logMAR or worse during the study
Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as perInvestigator's medical judgement; conditions including but not limited tokerato-uveitis, keratopathy, keratectasia
Previous intraocular or corneal/refractive surgery that might confound the outcomeof the investigation or increase the risk to the patient (including cornealtransplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxingincision etc.)
Any clinically significant condition that could affect IOL stability (e.g. zonulardialysis, evident zonular weakness or dehiscence, etc.)
Patients with diagnosed degenerative visual disorders (e.g. macular degeneration orother retinal disorders, optic nerve atrophy etc.) or any other pathologies of theeye that are predicted to result in a visual acuity of 0.2 logMAR or worse duringthe study
Current systemic or ocular pharmacotherapy that effects patients' vision withsignificant ocular side effects or any medications that could confound the outcomeor increase subject risk
Clinically significant gonioscopic abnormalities
Amblyopia, strabismus, single eye status
Rubella, congenital, traumatic or complicated cataracts
History of or current anterior or posterior segment inflammation, including but notlimited to iritis or uveitis
Microphthalmos or macrophthalmos
Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)
Pseudoexfoliation
Keratoconus or irregular astigmatism
Inability to measure keratometry or biometry (including but not limited to cataractdensity, etc.)
Pathologic miosis
Pregnant, plan to become pregnant, lactating during the course of the investigation,or another condition with associated fluctuation of hormones that could lead torefractive changes
Patients unable to meet the limitations of the protocol or likely of non-cooperationduring the trial
Patients whose freedom is impaired by administrative or legal order
Concurrent participation in another clinical investigation in the last 30 days.
Study Design
Study Description
Connect with a study center
Eye Hospital Zora
Sofia,
BulgariaActive - Recruiting
Specialized Ophthalmological Hospital for Active Treatment
Sofia,
BulgariaActive - Recruiting
Medical Center "Vereya"
Stara Zagora,
BulgariaActive - Recruiting
Nemocnice Havlíčkův
Havlíčkův Brod,
CzechiaActive - Recruiting
OFTEX ocni
Pardubice,
CzechiaActive - Recruiting
Oční Centrum
Prague,
CzechiaActive - Recruiting
Oculus Eye Clinic
Bucharest,
RomaniaSite Not Available
Oculus Eye Clinic
Bucuresti,
RomaniaSite Not Available
Ofta Total Clinic
Sibiu,
RomaniaSite Not Available
Medoptic Clinic
Suceava,
RomaniaSite Not Available
Oftalvist
Alicante,
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid,
SpainActive - Recruiting
OMIQ Hospital Universitari
Sant Cugat del Vallès,
SpainSite Not Available
University Hopital Complex of Santiago de Compostela
Santiago de Compostela,
SpainSite Not Available
Oftalvist
Valencia,
SpainActive - Recruiting

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