Objective Measurements of the Opacification of the Lens After Vitrectomy (MOCVIT)
Primary Purpose
Vitrectomy, Cataract
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Objective Scatter Index (OSI)
Average Lens Density (ALD)
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitrectomy focused on measuring Objective Scatter Index (OSI), Optical Quality Analysis System (OQAS), Average Lens Density (ALD), IOLMaster® 700
Eligibility Criteria
Inclusion Criteria:
- Patient over 18 years old
- Indication for unilateral 3-way vitrectomy for retinal detachment, macular hole, epiretinal membrane, vitreous hemorrhage
- Bilateral phakic patient
Exclusion Criteria:
- Vitrectomy combined with cataract surgery
- Pregnant or breastfeeding woman
Sites / Locations
- Hôpital Fondation A. de Rothschuld
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
24 months follow up after vitrectomy
Arm Description
Objective Scatter Index (OSI) and Average Lens Density (ALD) at inclusion, then 3 months, 12 months and 24 months after vitrectomy
Outcomes
Primary Outcome Measures
Change in ALD value between baseline and 12 months after the intervention
ALD value : quantitative variable expressed in pixel units
Secondary Outcome Measures
Full Information
NCT ID
NCT04566237
First Posted
September 17, 2020
Last Updated
February 14, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT04566237
Brief Title
Objective Measurements of the Opacification of the Lens After Vitrectomy
Acronym
MOCVIT
Official Title
Objective Measurements of the Opacification of the Lens After Vitrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitrectomy, Cataract
Keywords
Objective Scatter Index (OSI), Optical Quality Analysis System (OQAS), Average Lens Density (ALD), IOLMaster® 700
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
24 months follow up after vitrectomy
Arm Type
Experimental
Arm Description
Objective Scatter Index (OSI) and Average Lens Density (ALD) at inclusion, then 3 months, 12 months and 24 months after vitrectomy
Intervention Type
Procedure
Intervention Name(s)
Objective Scatter Index (OSI)
Intervention Description
On Optical Quality Analysis System (OQAS) device. At Inclusion, 3 months, 12 months and 24 months after vitrectomy
Intervention Type
Procedure
Intervention Name(s)
Average Lens Density (ALD)
Intervention Description
on IOLMaster® 700 device. At Inclusion, 3 months, 12 months and 24 months after vitrectomy
Primary Outcome Measure Information:
Title
Change in ALD value between baseline and 12 months after the intervention
Description
ALD value : quantitative variable expressed in pixel units
Time Frame
Baseline and 12 months after vitrectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient over 18 years old
Indication for unilateral 3-way vitrectomy for retinal detachment, macular hole, epiretinal membrane, vitreous hemorrhage
Bilateral phakic patient
Exclusion Criteria:
Vitrectomy combined with cataract surgery
Pregnant or breastfeeding woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphaël LEJOYEUX, MD
Organizational Affiliation
Hôpital Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Fondation A. de Rothschuld
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Objective Measurements of the Opacification of the Lens After Vitrectomy
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