Last reviewed · How we verify
NCT05146310: PROMIR
Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE®
NA trial testing I.SPACE® in Cataract in 81 participants. Completed in 1 March 2023.
1 March 2023
Quick facts
| Lead sponsor | Laboratoires Vivacy |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 81 |
| Start date | 6 December 2021 |
| Primary completion | 1 March 2023 |
| Estimated completion | 1 March 2023 |
| Sites | 3 locations across France |
Drugs / interventions tested
- I.SPACE®
Conditions studied
- Cataract — all drugs for Cataract →
Sponsor
Laboratoires Vivacy
Who can join
Adults 18 to 84, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
I.SPACE® is a hyaluronic acid injectable gel CE (European Conformity) marketed since 2010. It is indicated for use as a surgical aid in ophthalmic anterior segment surgery. The aim is to protect the corneal endothelium and maintains the intraocular space.The product should be instilled in the anterior chamber of the eye and adjusted according to the volume of the aqueous humour. In this study, 80 patients aged from 18 to 84 years' old at inclusion, who have at least one eye with cataract (mild to moderate severity) based on subjective ophthalmic examination by the investigator, who have given his/her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 7 visits over a period of 3 months. Protection of corneal endothelium (Mean percent change of CEC density) after baseline injection will be assessed. Surgeon's satisfaction during cataract surgery, mean change in Intraocular Pressure (IOP), percentage of eyes with IOP spikes ≥ 30mm mmHg, corneal thickness, intraocular inflammation, Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and safety will be also assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05146310
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cataract
Currently open trials in the same condition.
- NCT07301385 — Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety a · NA · recruiting
- NCT07462000 — Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract · NA · recruiting
- NCT06891092 — Vivinex Impress XY1-EM vs RayOne EMV · NA · recruiting
- NCT07218796 — Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compar · Phase 3 · recruiting
- NCT07218783 — Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compar · Phase 3 · recruiting
Other Laboratoires Vivacy trials
Trials by the same sponsor.
- NCT05809739 — Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck · NA · completed
- NCT05747456 — Study of a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face (FaceHyal) · NA · completed
- NCT05355454 — Study of STYLAGE® XXL for Volume Deficiency in the Mid-Face · NA · completed
- NCT05087732 — Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds · NA · completed
- NCT05009381 — Effectiveness and Safety of STYLAGE® XXL for Chin Augmentation in Chinese Adults · NA · completed
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 NCT05146310 (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 Laboratoires Vivacy
- Last refreshed: 29 November 2023
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/NCT05146310.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing