CataractIBSINCT04775849
Intraoperative Berger Space Imaging (IBSI)
A study testing Femtosecond Laser in people with Cataract and Macula Edema, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cataract, Macula Edema
- What is being tested?
- Femtosecond Laser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 20 May 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Preceding ocular surgery or trauma
- Pseudoexfoliation
- Recurrent intraocular inflammation of unknown etiology
- Uncontrolled glaucoma
- Uncontrolled systemic or ocular disease
- Blind fellow eye
Show all 13Show fewer
- Microphthalmus
- Corneal abnormality
- History of uveitis/iritis
- Iris neovascularization
- Proliferative diabetic retinopathy
- Macular degeneration or any other relevant macular diseases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Rupert Menapace, MD, 0140400 ext. 66300, rupert.menapace@meduniwien.ac.at
Christina Leydolt, MD, 0140400 ext. 79480, christina.leydolt@meduniwien.ac.at
About this study
Official title: Intraoperative Berger Space Imaging
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.
Read more
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
- Being tested
- Femtosecond Laser
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond LaserDevice
Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Berger Space Imaging | Experimental | Intraoperative OCT imaging of the space between the posterior capsule and the anterior hyaloid Receives: Device: Femtosecond Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: intraoperative
Secondary outcomes (2)
Difference of central macular thickness between time points
Difference in Central Macular Thickness (CMT) with time.
Measured: Baseline to 1day, 1 week, 3 weeks
Intraocular pressure in different timepoints
Intraocular pressure changes with time.
Measured: Baseline to 1day, 1 week, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start20 May 2019
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cataract surgery will be performed in individuals with age-related cataract.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
- Investigators
- Rupert Menapace, MD, Principal investigator, Medical Universitiy of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775849
- Sponsor's protocol ID
- IBSI - 2258/2018
- Acronym
- IBSI
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Berger Space Imaging
- ClinicalTrials.gov ID
- NCT04775849
- Acronym / sponsor ID
- IBSI / IBSI - 2258/2018
- Conditions
- Cataract, Macula Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cataract surgery will be performed in individuals with age-related cataract.
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Berger Space Imaging | Experimental | Device: Femtosecond LaserIntraoperative OCT imaging of the space between the posterior capsule and the anterior hyaloid |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Preceding ocular surgery or trauma
- Pseudoexfoliation
- Recurrent intraocular inflammation of unknown etiology
- Uncontrolled glaucoma
- Uncontrolled systemic or ocular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femtosecond LaserFemtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral | Device | Intraoperative Berger Space Imaging |
Primary outcome
The primary objective is a Berger Space larger than 400μm
Time frame: 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
2 secondary outcomes
Difference of central macular thickness between time points
Time frame: Baseline to 1day, 1 week, 3 weeks
Intraocular pressure in different timepoints
Time frame: Baseline to 1day, 1 week, 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupert Menapace, MD principal investigator
Medical Universitiy of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond Laser in people with Cataract and Macula Edema, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronika Röggla, MD (0140400 ext. 79450, veronika.roeggla@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is a Berger Space larger than 400μm (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.