Back to resultsEffect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient (VITRECAT)
Primary Purpose
Cataract, Vitreous Detachment
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
About this trial
This is an interventional other trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Adult emmetropic patient
- Without complete posterior vitreus detachment in both eyes before having surgery.
Exclusion Criteria:
- Diabetic retinopathy
- Ophthalmological treatment in progress
- History of ophthalmological surgery
Sites / Locations
- URC Fondation Ophtalmologique A de Rothschild
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cataract surgery
Arm Description
Patient acts as his own control
Outcomes
Primary Outcome Measures
Occurence of vitreous detachment in the operated eye
Secondary Outcome Measures
Full Information
NCT ID
NCT02783209
First Posted
May 12, 2016
Last Updated
February 1, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02783209
Brief Title
Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient
Acronym
VITRECAT
Official Title
Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Major difficulties of patient inclusions
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
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
This study evaluates the association between surgery of the cataract and posterior vitreous detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in the same group of patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Vitreous Detachment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cataract surgery
Arm Type
Other
Arm Description
Patient acts as his own control
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Primary Outcome Measure Information:
Title
Occurence of vitreous detachment in the operated eye
Time Frame
3 months after the cataract surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult emmetropic patient
Without complete posterior vitreus detachment in both eyes before having surgery.
Exclusion Criteria:
Diabetic retinopathy
Ophthalmological treatment in progress
History of ophthalmological surgery
Facility Information:
Facility Name
URC Fondation Ophtalmologique A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient
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