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Objective Measurements of Lens Opacification After Intravitreal Injections (MOC-IVT)

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ClinicalTrials.gov Identifier: NCT03964597
Recruitment Status : Withdrawn (Study abandoned before any submission (foreseeable organizational difficulties))
First Posted : May 28, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date May 24, 2019
First Posted Date May 28, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date September 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2019)
Value of the OSI (Objective Scatter Index) in one year of follow-up after IVT [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Objective Measurements of Lens Opacification After Intravitreal Injections
Official Title Objective Measurements of Lens Opacification After Intravitreal Injections (MOC-IVT)
Brief Summary

The main hypothesis is the opacification of the lens would be increase by the IVT.

The opacification of the lens can be objectived by :

  • the objective scatter index (OSI) on the OQAS device
  • the average lens density (ALD) on the IOLMaster device.

Eligible patients will be followed at least 12 months after in intravitreal injection and the opacification of their lens is regularly controlled with OSI and ALD.

The objective is to study the dynamics of lens opacification in IVT-treated eyes evaluated by OSI for at least 1 year.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with an indication for intravitreal injection (IVT) for medical condition.
Condition
  • Lens Opacification
  • Intravitreal Injections (IVT)
Intervention Diagnostic Test: Measurement of lens opacification
Measurement of OSI and ALD at inclusion and during post-IVT follow-up visits to M3, M6, and M12, +/- M18, +/- M24 and +/- M30.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 17, 2020)
0
Original Estimated Enrollment
 (submitted: May 24, 2019)
150
Actual Study Completion Date September 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • An indication of an intravenous injection of a dexamethasone 700 μg (Ozurdex®) or anti-VEGF for at least one of the two eyes for macular edema or neovessels linked to DMLA, retinal venous occlusion, diabetic macular edema or posterior uveitis
  • Phake patient, at least of the injected eye

Exclusion criteria:

- Pseudophakia of the injected eye

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03964597
Other Study ID Numbers EBA_2019_9
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date January 2020