Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Berger Space Imaging | Experimental | Intraoperative OCT imaging of the space between the posterior capsule and the anterior hyaloid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond Laser | Device | Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is a Berger Space larger than 400μm | The number of patients with visible Berger space and the capacity (volume) of the visible Berger Space will be determined by using the intraoperative OCT recording | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of central macular thickness between time points | Difference in Central Macular Thickness (CMT) with time. | Baseline to 1day, 1 week, 3 weeks |
| Intraocular pressure in different timepoints |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronika Röggla, MD | Contact | 0140400 | 79450 | veronika.roeggla@meduniwien.ac.at |
| Christina Leydolt, MD | Contact | 0140400 | 79480 | christina.leydolt@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Rupert Menapace, MD | Medical Universitiy of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Cataract surgery will be performed in individuals with age-related cataract.
Not provided
Not provided
Not provided
Not provided
Intraocular pressure changes with time.
| Baseline to 1day, 1 week, 3 weeks |