Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-05-20
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery
NCT03465124
Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence
NCT03390400
Cataract Surgery: Femto LDV Z8 Versus Conventional
NCT02351271
Release of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Compared to Manual Cataract Surgery
NCT03390361
Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery
NCT02898909
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intraoperative Berger Space Imaging
Intraoperative OCT imaging of the space between the posterior capsule and the anterior hyaloid
Femtosecond Laser
Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Femtosecond Laser
Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rupert Menapace
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rupert Menapace, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Universitiy of Vienna
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Vienna
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IBSI - 2258/2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.