Intraoperative Berger Space Imaging (IBSI)

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT04775849

Collaborator

(none)

Enrollment

Location

Arm

42.4

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Macula Edema	Device: Femtosecond Laser	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Cataract surgery will be performed in individuals with age-related cataract.Cataract surgery will be performed in individuals with age-related cataract.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Intraoperative Berger Space Imaging

Actual Study Start Date :

May 20, 2019

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The primary objective is a Berger Space larger than 400μm [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 Outcome Measures

Difference of central macular thickness between time points [Baseline to 1day, 1 week, 3 weeks]
Difference in Central Macular Thickness (CMT) with time.
Intraocular pressure in different timepoints [Baseline to 1day, 1 week, 3 weeks]
Intraocular pressure changes with time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Rupert Menapace, MD, Medical Universitiy of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rupert Menapace, Clinical Professor, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT04775849

Other Study ID Numbers:

IBSI - 2258/2018

First Posted:

Mar 1, 2021

Last Update Posted:

Mar 1, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Mar 1, 2021