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WithdrawnNCT03964597MOC-IVTUpdated Jan 22, 2020

Objective Measurements of Lens Opacification After Intravitreal Injections

An observational study in Lens Opacification and Intravitreal Injections (IVT), sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Why this study was withdrawn
Study abandoned before any submission (foreseeable organizational difficulties)
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lens Opacification
  • Intravitreal Injections (IVT)

Keywords

  • Cataract
  • objective scatter index (OSI)
  • average lens density (ALD)
03

In context

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with an indication for intravitreal injection (IVT) for medical condition.

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

Exclusion criteria:

  • Pseudophakia of the injected eye
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testMeasurement 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03964597
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
May 28, 2019
Start date
Sep 1, 2019
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Last update
Jan 22, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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