Intraoperative Berger Space Imaging (IBSI)
Status
Conditions
Treatments
Details and patient eligibility
About
The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.
The laser will be reduced to image the Berger space. If not visible, the space will be enhanced with BSS and Volon A to visualize the BS.
Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.
Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination and retinal oct imaging.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
- Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
- Preoperative pupil size in mydriasis ≥ 6.0 mm
Exclusion criteria
- Preceding ocular surgery or trauma
- Pseudoexfoliation
- Recurrent intraocular inflammation of unknown etiology
- Uncontrolled glaucoma
- Uncontrolled systemic or ocular disease
- Blind fellow eye
- Microphthalmus
- Corneal abnormality
- History of uveitis/iritis
- Iris neovascularization
- Proliferative diabetic retinopathy
- Macular degeneration or any other relevant macular diseases
- Pregnancy
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Veronika Röggla, MD; Christina Leydolt, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal