Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566237
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2020-09-17
Brief Title:
Objective Measurements of the Opacification of the Lens After Vitrectomy
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Objective Measurements of the Opacification of the Lens After Vitrectomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOCVIT
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None