Proliferative Diabetic RetinopathyNCT05938491
OCT and OCT-A Afer Diabetic Vitrectomy in PDR
An observational study of Proliferative Diabetic Retinopathy, run by Assiut University.
Trial summary
Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR ) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- OCT and OCT-A
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with complicated proliferative diabetic retinopathy underwent pars plana vitrectomy
Who may be able to join
- Cases with complicated PDR as persistant vitreous hemorrhage or tractional retinal detachment involving or threatening the macula underwent PPV with or without ILM peeling
Who cannot join
- eyes with media opacity after PPV not allowing imaging of the macula
Trial locations and contacts
No sites are listed yet.
About this study
Official title: OCT and OCT Angiography After Diabetic Vitrectomy With or Without Internal Limiting Membrane Peeling for Patients With PDR
Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR )
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- OCT and OCT-A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT and OCT-ADiagnostic test
OCT and OCT angiography for the macula
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT and OCT angiography to assess the macular thickness , outline and vascularity
Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR ) .
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Assiut 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Abdelkarem Hasan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938491
- Sponsor's protocol ID
- oct after diabetic vitrectomy
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT and OCT Angiography After Diabetic Vitrectomy With or Without Internal Limiting Membrane Peeling for Patients With PDR
- ClinicalTrials.gov ID
- NCT05938491
- Acronym / sponsor ID
- oct after diabetic vitrectomy
- Conditions
- Proliferative Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 10 Jul 2023 (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.
Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR )
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with complicated proliferative diabetic retinopathy underwent pars plana vitrectomy
Key inclusion criteria (1 listed)
- Cases with complicated PDR as persistant vitreous hemorrhage or tractional retinal detachment involving or threatening the macula underwent PPV with or without ILM peeling
Key exclusion criteria (1 listed)
- eyes with media opacity after PPV not allowing imaging of the macula
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 |
|---|---|---|
| OCT and OCT-AOCT and OCT angiography for the macula | Diagnostic test | – |
Primary outcome
OCT and OCT angiography to assess the macular thickness , outline and vascularity
Time frame: 3 months after surgery
Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR ) .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Proliferative Diabetic Retinopathy, run by Assiut 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 1 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: status not confirmed, as of the sponsor's last update on 10 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Abdelkarem Hasan, M.B.B.CH (00201000525341, oabdelkarem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT and OCT angiography to assess the macular thickness , outline and vascularity (time frame: 3 months after surgery). 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 10 Jul 2023.