Intraoperative Berger Space Imaging (IBSI)

Cataract Clinical Trial

— IBSI  

Official title:

Intraoperative Berger Space Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775849
• Other study ID #: IBSI - 2258/2018
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2021
• Source: Medical University of Vienna
• Contact: Veronika Röggla, MD
• Phone: 0140400
• Email: veronika.roeggla[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Macula Edema

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference of central macular thickness between time points	Difference in Central Macular Thickness (CMT) with time.	Baseline to 1day, 1 week, 3 weeks
Secondary	Intraocular pressure in different timepoints	Intraocular pressure changes with time.	Baseline to 1day, 1 week, 3 weeks