Intraoperative Berger Space Imaging (IBSI)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Intraoperative Berger Space Imaging

Conditions
-----------------
Cataract, Macula Edema

Intervention / Treatment
-----------------
* Device: Femtosecond Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Cataract surgery will be performed in individuals with age-related cataract.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative Berger Space Imaging<br>Intraoperative OCT imaging of the space between the posterior capsule and the anterior hyaloid | Device: Femtosecond Laser<br>* Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Intraocular pressure changes with time. | Baseline to 1day, 1 week, 3 weeks |