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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Recruitment Status : Withdrawn (Study abandoned before any submission (foreseeable organizational difficulties))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

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.


Condition or disease Intervention/treatment
Lens Opacification Intravitreal Injections (IVT) Diagnostic Test: Measurement of lens opacification

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Objective Measurements of Lens Opacification After Intravitreal Injections (MOC-IVT)
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Value of the OSI (Objective Scatter Index) in one year of follow-up after IVT [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an indication for intravitreal injection (IVT) for medical condition.
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

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03964597    
Other Study ID Numbers: EBA_2019_9
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Cataract
objective scatter index (OSI)
average lens density (ALD)