Last reviewed · How we verify
NCT04566237: MOCVIT
Objective Measurements of the Opacification of the Lens After Vitrectomy
NA trial testing Objective Scatter Index (OSI) in Vitrectomy in 44 participants. Completed in 12 December 2024.
12 December 2024
Quick facts
| Lead sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 44 |
| Start date | 21 September 2020 |
| Primary completion | 12 December 2024 |
| Estimated completion | 12 December 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Objective Scatter Index (OSI)
- Average Lens Density (ALD)
Conditions studied
- Vitrectomy — all drugs for Vitrectomy →
- Cataract — all drugs for Cataract →
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild — full company profile →
Who can join
18 and older, any sex, with Vitrectomy or Cataract. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years. In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication. The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units. Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group. To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.
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 NCT04566237
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Fondation Ophtalmologique Adolphe de Rothschild trials
Trials by the same sponsor.
- NCT04701619 — Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies (IMMUNOSTROKE) · NA · not yet recruiting
- NCT04763161 — Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Cas · not yet recruiting
- NCT06264531 — Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous M · Phase 2, PHASE3 · recruiting
- NCT06895044 — Evolution of Ocular Growth in Myopic Children: A Prospective Cohort Study · recruiting
- NCT06644196 — Creation of a Database of Images of the Eye With the Holographic Doppler Laser · recruiting
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 NCT04566237 (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 Fondation Ophtalmologique Adolphe de Rothschild
- Last refreshed: 13 February 2025
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/NCT04566237.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing