Pseudophakic Cystoid Macular EdemaNCT05117411
Optical Coherence Tomography Angiography and Pseudophakic Cystoid Edema
An observational study of Pseudophakic Cystoid Macular Edema, run by Federico II University.
Trial summary
This study evaluates the retinal vascular features in macula and papillary regions in patients affected by pseudophakic cystoid edema using optical coherence tomography angiography Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pseudophakic Cystoid Macular Edema
- What is being tested?
- OCTA and pseudophakin cystoid edema
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2020
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participans were older than 18 years with diagnosis of pseudophakic cystoid macular oedema. The participans did not present other ophthalmological diseases.
Who may be able to join
- age older than 60 years
- diagnosis of pseudophakic cystoid macular oedema
- treatment-naïve for pseudophakic cystoid macular oedema
- absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)
Who cannot join
- age younger than 60 years
- No diagnosis of pseudophakic cystoid macular oedema
- previous treatment for pseudophakic cystoid macular oedema
- presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)
About this study
Official title: Peripapillary Vascular Density in the Pathogenesis of Pseudophakic Cystoid Edema
This study evaluates the retinal vascular features in macula and papillary regions in patients affected by pseudophakic cystoid edema using optical coherence tomography angiography
Read the detailed description
Pseudophakic cystoid edema represents one of the most common causes of poor visual outcome following cataratta surgery.
It is still source of debate the pathogenesis of Pseudophakic cystoid edema. Optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features. The study evaluates retrospectively the changes in optical coherence tomography angiography parameters at baseline and after three monthly after surgery.
- Conditions
- Pseudophakic Cystoid Macular Edema
- Being tested
- OCTA and pseudophakin cystoid edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTA and pseudophakin cystoid edemaDiagnostic test
Patients underwent OCT angiografia after cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Subjects over 18 years that after cataract surgery, showed pseudophakic cystoid macula edema. Receives: Diagnostic Test: OCTA and pseudophakin cystoid edema | |
| Control Group | Normal subjects over 18 years that did not show pseudophakic cystoid macula edema. Receives: Diagnostic Test: OCTA and pseudophakin cystoid edema |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCTA and pseudophakic cystoid macular oedema
The parameters analyzed by OCTA three months after surgery are:
Vessel density (%) of superficial capillary plexus, deep capillary plexus, coriocapillary plexus in macular region Vessel density (%) of radial peripapillary capillary plexus in papilllary region
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jan 2016
- Primary completion15 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudophakic Cystoid Macular EdemaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, Principal investigator, Università Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117411
- Sponsor's protocol ID
- 09/21
- Status last verified
- Nov 2021
- First submitted
- 27 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripapillary Vascular Density in the Pathogenesis of Pseudophakic Cystoid Edema
- ClinicalTrials.gov ID
- NCT05117411
- Acronym / sponsor ID
- 09/21
- Conditions
- Pseudophakic Cystoid Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Nov 2021 (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.
This study evaluates the retinal vascular features in macula and papillary regions in patients affected by pseudophakic cystoid edema using optical coherence tomography angiography
Detailed description
Pseudophakic cystoid edema represents one of the most common causes of poor visual outcome following cataratta surgery.
It is still source of debate the pathogenesis of Pseudophakic cystoid edema. Optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features. The study evaluates retrospectively the changes in optical coherence tomography angiography parameters at baseline and after three monthly after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Diagnostic Test: OCTA and pseudophakin cystoid edemaSubjects over 18 years that after cataract surgery, showed pseudophakic cystoid macula edema. |
| Control Group | – | Diagnostic Test: OCTA and pseudophakin cystoid edemaNormal subjects over 18 years that did not show pseudophakic cystoid macula edema. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 18 years with diagnosis of pseudophakic cystoid macular oedema. The participans did not present other ophthalmological diseases.
Key inclusion criteria (4 listed)
- age older than 60 years
- diagnosis of pseudophakic cystoid macular oedema
- treatment-naïve for pseudophakic cystoid macular oedema
- absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)
Key exclusion criteria (4 listed)
- age younger than 60 years
- No diagnosis of pseudophakic cystoid macular oedema
- previous treatment for pseudophakic cystoid macular oedema
- presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)
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 |
|---|---|---|
| OCTA and pseudophakin cystoid edemaPatients underwent OCT angiografia after cataract surgery | Diagnostic test | Control Group, Patients group |
Primary outcome
OCTA and pseudophakic cystoid macular oedema
Time frame: 3 months
The parameters analyzed by OCTA three months after surgery are: Vessel density (%) of superficial capillary plexus, deep capillary plexus, coriocapillary plexus in macular region Vessel density (%) of radial peripapillary capillary plexus in papilllary region
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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.
Gilda Cennamo principal investigator
Università Federico II
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudophakic Cystoid Macular Edema, run by Federico II University.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Nov 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OCTA and pseudophakic cystoid macular oedema (time frame: 3 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 11 Nov 2021.