Status:
UNKNOWN
Intraoperative Berger Space Imaging (IBSI)
Lead Sponsor:
Medical University of Vienna
Conditions:
Cataract
Macula Edema
Eligibility:
All Genders
40-90 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04775849
Start Date
May 20 2019
End Date
November 30 2022
Last Update
March 1 2021
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090