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Intraoperative Berger Space Imaging (IBSI) (IBSI)

Primary Purpose

Cataract, Macula Edema

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Femtosecond Laser
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative Berger Space Imaging

Arm Description

Intraoperative OCT imaging of the space between the posterior capsule and the anterior hyaloid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference of central macular thickness between time points
Difference in Central Macular Thickness (CMT) with time.
Intraocular pressure in different timepoints
Intraocular pressure changes with time.

Full Information

First Posted
February 23, 2021
Last Updated
February 26, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04775849
Brief Title
Intraoperative Berger Space Imaging (IBSI)
Acronym
IBSI
Official Title
Intraoperative Berger Space Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Macula Edema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cataract surgery will be performed in individuals with age-related cataract.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative Berger Space Imaging
Arm Type
Experimental
Arm Description
Intraoperative OCT imaging of the space between the posterior capsule and the anterior hyaloid
Intervention Type
Device
Intervention Name(s)
Femtosecond Laser
Intervention Description
Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral
Primary Outcome Measure Information:
Title
The primary objective is a Berger Space larger than 400μm
Description
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
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Difference of central macular thickness between time points
Description
Difference in Central Macular Thickness (CMT) with time.
Time Frame
Baseline to 1day, 1 week, 3 weeks
Title
Intraocular pressure in different timepoints
Description
Intraocular pressure changes with time.
Time Frame
Baseline to 1day, 1 week, 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronika Röggla, MD
Phone
0140400
Ext
79450
Email
veronika.roeggla@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Leydolt, MD
Phone
0140400
Ext
79480
Email
christina.leydolt@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, MD
Organizational Affiliation
Medical Universitiy of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, MD
Phone
0140400
Ext
66300
Email
rupert.menapace@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Christina Leydolt, MD
Phone
0140400
Ext
79480
Email
christina.leydolt@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

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Intraoperative Berger Space Imaging (IBSI)

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