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

Phase 4

• Conditions: Cataract; H26.9; Cataract, unspecified

• Registration Number: DRKS00010594
• Lead Sponsor: niversitätsklinikum Knappschaftskrankenhaus Bochum GmbH Augenklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-18
• Study Completion: 2017-09-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Visual acuity reducing cataract (LOCS III Grading, 1-5)
- Visual acuity <= 0,63 dec
- Age >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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparision of binocular visual acuity for far and near distance under mesopic light conditions<br>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 Outcome Measures

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