Lens OpacificationMOC-IVTNCT03964597
Objective Measurements of Lens Opacification After Intravitreal Injections
An observational study of Lens Opacification and Intravitreal Injections (IVT), run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lens Opacification, Intravitreal Injections (IVT)
- What is being tested?
- Measurement of lens opacification
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for intravitreal injection (IVT) for medical condition.
Who may be able to join
- 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
Who cannot join
- Pseudophakia of the injected eye
About this study
Official title: Objective Measurements of Lens Opacification After Intravitreal Injections (MOC-IVT)
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.
- Conditions
- Lens Opacification, Intravitreal Injections (IVT)
- Being tested
- Measurement of lens opacification
- Keywords
- Cataract, objective scatter index (OSI), average lens density (ALD)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of lens opacificationDiagnostic test
Measurement of OSI and ALD at inclusion and during post-IVT follow-up visits to M3, M6, and M12, +/- M18, +/- M24 and +/- M30.
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of the OSI (Objective Scatter Index) in one year of follow-up after IVT
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: Study abandoned before any submission (foreseeable organizational difficulties)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lens OpacificationStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964597
- Sponsor's protocol ID
- EBA_2019_9
- Acronym
- MOC-IVT
- Status last verified
- Jan 2020
- First submitted
- 24 May 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Measurements of Lens Opacification After Intravitreal Injections (MOC-IVT)
- ClinicalTrials.gov ID
- NCT03964597
- Acronym / sponsor ID
- MOC-IVT / EBA_2019_9
- Conditions
- Lens Opacification, Intravitreal Injections (IVT)
- Keywords
- Cataract, objective scatter index (OSI), average lens density (ALD)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study abandoned before any submission (foreseeable organizational difficulties)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for intravitreal injection (IVT) for medical condition.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Pseudophakia of the injected eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of lens opacificationMeasurement of OSI and ALD at inclusion and during post-IVT follow-up visits to M3, M6, and M12, +/- M18, +/- M24 and +/- M30. | Diagnostic test | – |
Primary outcome
Value of the OSI (Objective Scatter Index) in one year of follow-up after IVT
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lens Opacification and Intravitreal Injections (IVT), run by Fondation Ophtalmologique Adolphe de Rothschild.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of the OSI (Objective Scatter Index) in one year of follow-up after IVT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.