Intraoperative Berger Space Imaging (IBSI)

NCT04775849 | Unknown DMC

• 1 other identifier: IBSI - 2258/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Macula Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference of central macular thickness between time points

  Baseline to 1day, 1 week, 3 weeks

• Intraocular pressure in different timepoints

  Baseline to 1day, 1 week, 3 weeks

Study Arms (1)

Intraoperative Berger Space Imaging

EXPERIMENTAL

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

Device: Femtosecond Laser

Interventions

Femtosecond Laser DEVICE

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

Intraoperative Berger Space Imaging

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Rupert Menapace, MD

  Medical Universitiy of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronika Röggla, MD

CONTACT

0140400; veronika.roeggla@meduniwien.ac.at

Christina Leydolt, MD

CONTACT

0140400; christina.leydolt@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

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

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: May 20, 2019
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)