Intraoperative Berger Space Imaging (IBSI)

Not Applicable

• Conditions: Macula Edema; Cataract
• Interventions: Device: Femtosecond Laser

• Registration Number: NCT04775849
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-20
• Status Verified: 2021-02
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative Berger Space Imaging	Femtosecond Laser	Intraoperative OCT imaging of the space between the posterior capsule and the anterior hyaloid

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria