Intraoperative Berger Space Imaging (IBSI) (IBSI)

Intraoperative Berger Space Imaging

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 Overview

• Status: Recruiting
• Conditions: Cataract; Macula Edema
• Intervention / Treatment: Device: Femtosecond Laser

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronika Röggla, MD; Phone Number: 79450 0140400; Email: veronika.roeggla@meduniwien.ac.at
• Study Contact Backup: Name: Christina Leydolt, MD; Phone Number: 79480 0140400; Email: christina.leydolt@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Christina Leydolt, MD; Phone Number: 79480 0140400; Email: christina.leydolt@meduniwien.ac.at
    • Contact: Rupert Menapace, MD; Phone Number: 66300 0140400; Email: rupert.menapace@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Rupert Menapace, MD, Medical Universitiy of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IBSI - 2258/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No