Traction-free vitreous body removal: the evaluation of the safety and effectiveness within the framework of 3 pathologies in operative retinal and vitreous body surgery
Recruiting
- Conditions
- Retinal Detachment,Macular Disease,Diabetic Retinopathy
- Registration Number
- DRKS00026046
- Lead Sponsor
- niversity Hospital Frankfurt Department of Ophthalmology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Patients requiring one or more intraocular surgical interventions with 3 clinical pictures (macular diseases, retinal detachments, diabetic retinopathy), ability to give consent, signed patient consent, age equal to or greater than 18 years
Exclusion Criteria
Condition after a serious eye injury, pregnant or breastfeeding, age less than 18 years
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety endpoint: Interoperative and postoperative adverse events
- Secondary Outcome Measures
Name Time Method Performance endpoints: Effectiveness assessed by surgeon (post-operative questionnaire which is completed directly following the surgery within the first 24 hrs post operatively), duration of operation, device settings.<br><br>Other performance measurements: Development of vision (visual acuity pre- and post-operative),<br>findings from slit lamp and indirect ophthalmoscopy, applanation tonometry, color fundus photography,<br>optical coherence tomography, signs of proliferative vitreoretinopathy, influence of the eye axis length, retinal condition / pretreatment