OphthalmopathyNCT05494229
Autologous Blood for Full-thickness Macular Hole
A study testing Pars-plana vitrectomy in people with Ophthalmopathy, run by Omer Othman Abdullah at 1 site in Iraq.
Trial summary
Autologous blood for primary and recurrent holes Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ophthalmopathy
- What is being tested?
- Pars-plana vitrectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2022to 1 Mar 2023
- Phase
- Interventional
- 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
Who may be able to join
- Primary and recurrent holes
Who cannot join
- Lamellar and pseudoholes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Whole Blood for Closing Full-thickness Macular Hole
Autologous blood for primary and recurrent holes
Read the detailed description
Utilizing whole autologous blood for closing both primary and recurrent holes. Here, we apply a drop of the taken whole blood over the hole, and the access blood will be aspirated on the macula with a silicon-tipped active back-flash cannula, to abolish all the possibilities of the fibrinogenic behavior of the whole blood composition, which might cause traction and recurrent hole formation. Therefore, only the hole will be filled with blood. The blood will be taken under completely sterile and aseptic conditions.
The air infusion will be raised after the valve of one of the trocars will be removed, to allow the air current to dry the clot inside the hole rapidly. Then air gas exchange will be performed to allow the clot to remain away from intraocular fluids for one to two weeks and abolish the possibility of the clot being dissolved.
- Conditions
- Ophthalmopathy
- Being tested
- Pars-plana vitrectomy
- Keywords
- Full Thickness Macular Hole, Blood Clot, Whole blood, Pars-pana vitrectomy
- Medical subject headings
- Eye Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars-plana vitrectomyOther
Pars-plana vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Utilizing autologous whole blood for the full thickness macular hole | Experimental | It is an interventional study by performing pars-plana vitrectomy Receives: Other: Pars-plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical outcome
OCT
Measured: The fourth week post-operatively
Secondary outcomes (1)
Functional outcome
Best corrected visual acuity
Measured: The fourth week post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Why it stopped: Due to complications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmopathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omer Othman Abdullah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omer Othman Abdullah, Ibinsina Modern Eye and Retina Center
- Investigators
- Omer Abdullah, M.Sc., Principal investigator, Ibinsina Modern Eye and Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494229
- Sponsor's protocol ID
- IMER 111
- Status last verified
- Mar 2023
- First submitted
- 6 Aug 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Whole Blood for Closing Full-thickness Macular Hole
- ClinicalTrials.gov ID
- NCT05494229
- Acronym / sponsor ID
- IMER 111
- Conditions
- Ophthalmopathy
- Keywords
- Full Thickness Macular Hole, Blood Clot, Whole blood, Pars-pana vitrectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to complications
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Omer Othman AbdullahUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 9 Aug 2022 (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.
Autologous blood for primary and recurrent holes
Detailed description
Utilizing whole autologous blood for closing both primary and recurrent holes. Here, we apply a drop of the taken whole blood over the hole, and the access blood will be aspirated on the macula with a silicon-tipped active back-flash cannula, to abolish all the possibilities of the fibrinogenic behavior of the whole blood composition, which might cause traction and recurrent hole formation. Therefore, only the hole will be filled with blood. The blood will be taken under completely sterile and aseptic conditions.
The air infusion will be raised after the valve of one of the trocars will be removed, to allow the air current to dry the clot inside the hole rapidly. Then air gas exchange will be performed to allow the clot to remain away from intraocular fluids for one to two weeks and abolish the possibility of the clot being dissolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Utilizing autologous whole blood for the full thickness macular hole | Experimental | Other: Pars-plana vitrectomyIt is an interventional study by performing pars-plana vitrectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary and recurrent holes
Key exclusion criteria (1 listed)
- Lamellar and pseudoholes
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 |
|---|---|---|
| Pars-plana vitrectomyPars-plana vitrectomy | Other | Utilizing autologous whole blood for the full thickness macular hole |
Primary outcome
Anatomical outcome
Time frame: The fourth week post-operatively
OCT
1 secondary outcome
Functional outcome
Time frame: The fourth week post-operatively.
Results and safety
The study was stopped early (reason given: Due to complications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- 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.
Omer Abdullah, M.Sc. principal investigator
Ibinsina Modern Eye and Retina Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars-plana vitrectomy in people with Ophthalmopathy, run by Omer Othman Abdullah at 1 site in Iraq.
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: stopped early, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Due to complications). Results are not available in the source record.
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?
Anatomical outcome (time frame: The fourth week post-operatively). 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 27 Mar 2023.