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NCT04775849: IBSI
Intraoperative Berger Space Imaging (IBSI)
NA trial testing Femtosecond Laser in Cataract in 80 participants. Status unknown.
31 October 2022
Quick facts
| Lead sponsor | Medical University of Vienna |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 80 |
| Start date | 20 May 2019 |
| Primary completion | 31 October 2022 |
| Estimated completion | 30 November 2022 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Femtosecond Laser
Conditions studied
- Cataract — all drugs for Cataract →
- Macula Edema — all drugs for Macula Edema →
Sponsor
Medical University of Vienna
Who can join
Adults 40 to 90, any sex, with Cataract or Macula Edema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04775849
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04775849 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Vienna
- Last refreshed: 1 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04775849.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing