Intraoperative Berger Space Imaging (IBSI)

Intraoperative Berger Space Imaging

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04775849

Acronym

IBSI

Enrollment

Registered

2021-03-01

Start date

2019-05-20

Completion date

2022-11-30

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Macula Edema

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.

Interventions

DEVICEFemtosecond Laser

Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Austria

Contacts

Primary ContactVeronika Röggla, MD

veronika.roeggla@meduniwien.ac.at0140400

Backup ContactChristina Leydolt, MD

christina.leydolt@meduniwien.ac.at0140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026