Intraoperative Berger Space Imaging
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Medical University of Vienna
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- The primary objective is a Berger Space larger than 400μm
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The primary objective is a Berger Space larger than 400μm
Time Frame: intraoperative
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
Secondary Outcomes
- Difference of central macular thickness between time points(Baseline to 1day, 1 week, 3 weeks)
- Intraocular pressure in different timepoints(Baseline to 1day, 1 week, 3 weeks)
Investigators
Rupert Menapace
Clinical Professor
Medical University of Vienna