MOC-IVT: Objective Measurements of Lens Opacification After Intravitreal Injections

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03964597
• Collaborator: (none)
• Enrollment: 0

Study Details

Study Description

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	Phase
Lens Opacification; Intravitreal Injections (IVT)	Diagnostic Test: Measurement of lens opacification

Study Design

• 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: Sep 1, 2019
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Sep 1, 2019

Outcome Measures

Primary Outcome Measures

1. Value of the OSI (Objective Scatter Index) in one year of follow-up after IVT [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT03964597
• Other Study ID Numbers: EBA_2019_9
• First Posted: May 28, 2019
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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)

Study Results

No Results Posted as of Jan 22, 2020