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Interindividual Comparison Trial – Two intraocular lenses with extended depth of focus

Interindividual Comparison Trial – Two intraocular lenses with extended depth of focus - IC8 vs. Symfony

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010594
Enrollment
40
Registered
2016-07-18
Start date
2016-08-23
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract H26.9

Interventions

Group 1: IC-8 Group: Implantation of IC-8 IOL into nondominant eye, Implantation of monofacal, aspherical IOL (Tecnis 1-piece, Abbott Medical Optics, Santa Ana, California, USA) into dominant eye Grou

Sponsors

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH Augenklinik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to No maximum

Inclusion criteria

Inclusion criteria: - Visual acuity reducing cataract (LOCS III Grading, 1-5) - Visual acuity 22 year - planned Cataract surgery for both eyes - potential visual acuity after surgery >= 0,8 dec. - clear ocular media, except cataract - voluntary participation in the study - understood and signed informed consent

Exclusion criteria

Exclusion criteria: - IOL power outside the range of +20.0 D to +27,0 D - Dilated pupil size of less than 6.0 mm - Pupillary abnormalities - microphthalmos - Prior corneal surgery or intraocular surgery - Astigmatism> 0.75 diopters, irregular astigmatism - corneal abnormalities or degenerative disease to reduce the visual acuity during the study to 0.63 or lower - Active inflammation, diseases, pathologies or infection of the anterior or posterior segment of the eye - Glaucoma or ocular hypertension uncontrolled - Congenital cataracts - Initial situations with increased risk of zonula defects (as Pseudoexfoliation or trauma to the eye in the history) - Medication that may affect the visual acuity - Antidepressant or antipsychotic medications - Intraoperative Floppy Iris Syndrome (IFIS) (using alpha-antagonists (for example, tamsulosin) - Acute, chronic or uncontrolled systemic diseases, in the opinion of the examiner an influence on the results of the study (for example, immunosuppression, connective tissue, hypertension, etc.) - Dry eye or the regular use of artificial tears - Poorly controlled diabetes mellitus or insulin-dependent diabetes mellitus - Pregnancy, planned pregnancy or breastfeeding - Current participation or participation in the last 30 days in another study

Design outcomes

Primary

MeasureTime frame
Comparision of binocular visual acuity for far and near distance under mesopic light conditions between the IC-8-Group and the Symfony-Group (distance corrected and target corrected; 85cd/m2; 3cd/m2) at 1 month and 3 month after surgery, using grating patterns of different spatial frequency with decreasing contrast.

Secondary

MeasureTime frame
Comparision of binocular visual acuity for far and near distance unter photopic light conditions (distance corrected and target corrected; 10% contrast) Binocular defocuscurve at photopic conditions (target corrected, +2,0 D to -4,0 D) at 1 month and 3 month after surgery.

Countries

Germany

Contacts

Public ContactTim Schultz

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH Augenklinik

tim.schultz@kk-bochum.de+49-(0)234-299-3142

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026