Phase
Condition
Eye Disorders/infections
Eye Disease
Vision Loss
Treatment
HECATE
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years or older;
Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataractextraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOLDiopter range of +15.0D to +27.0D
No visual acuity limiting pathologies other than cataract;
Corneal Astigmatism of <1.0 D;
Availability, willingness, and sufficient cognitive awareness to comply withexamination procedures;
Written informed consent for participation in the study and data protection.
Exclusion
Exclusion Criteria:
Corneal Astigmatism of ≥1.0 D;
Difficulty for cooperation (distance from their home, general health conditions);
History of acute or chronic disease, pathology, illness, or ocular trauma thatwould, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT,glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema,proliferative diabetic retinopathy, amblyopia, etc.);
Visual field loss which has an impact on visual acuity;
Use of systemic or ocular medication that might affect vision;
Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis,abnormally shaped pupils or pupils that do not dilate under mesopic/scotopicconditions);
Capsular or zonular abnormalities that may affect postoperative centration or tiltof the lens (e.g., pseudoexfoliation syndrome);
Cataract grades of 4, 5 or 6 on the LOCSIII scale ;
Surgeries with incision size of ≥2.75mm ;
Immediate Sequential Bilateral Cataract Surgery ;
Concurrent participation in another device investigation;
Usage of contact lenses during participation.
Study Design
Connect with a study center
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
PVK Precise Vision GmbH
Rheine, 48429
GermanySite Not Available
Dr. Pedro Tañá Rivero
Alicante, 03001
SpainSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.