Iris DiseaseNCT04011878
Histopathological Examination of Iris Tissue in Buphthalmos
A study testing Combined trabeculotomy trabeculectomy with mitomycin C in people with Iris Disease, run by Assiut University.
Trial summary
To revise the etiology of the primary congenital glaucoma in some infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iris Disease
- What is being tested?
- Combined trabeculotomy trabeculectomy with mitomycin C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Oct 2018
- 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
- infants under age of 2 years
- 1ery glaucoma
Who cannot join
- infants more than 2 years
- 2ery glaucoma
- previous glaucoma surgery
About this study
To revise the etiology of the primary congenital glaucoma in some infants.
Read the detailed description
Combined trabeculotomy trabeculectomy with mitomycin C was done in 11 eyes. Histopathological examination of the peripheral iris tissue specimen was done in all cases.
- Conditions
- Iris Disease
- Being tested
- Combined trabeculotomy trabeculectomy with mitomycin C
- Medical subject headings
- Iris Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined trabeculotomy trabeculectomy with mitomycin CProcedure or surgery
Combined trabeculotomy trabeculectomy with mitomycin C with histopathological examination of the peripheral iris tissue specimen of all cases
| Study group | Role | What they receive |
|---|---|---|
| isolated trabeculodysgensis | Experimental | etiology of primary congenital glaucoma Receives: Procedure: Combined trabeculotomy trabeculectomy with mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrovascular membrane over iris surface
angle closure by a fibrovascular tissue proliferation over the trabecular meshwork in the anterior chamber angle.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study startJan 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iris DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Lotfy Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011878
- Sponsor's protocol ID
- 2323299
- Status last verified
- Jul 2019
- First submitted
- 4 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Examination of Iris Tissue in Buphthalmos
- ClinicalTrials.gov ID
- NCT04011878
- Acronym / sponsor ID
- 2323299
- Conditions
- Iris Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Jul 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.
To revise the etiology of the primary congenital glaucoma in some infants.
Detailed description
Combined trabeculotomy trabeculectomy with mitomycin C was done in 11 eyes. Histopathological examination of the peripheral iris tissue specimen was done in all cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isolated trabeculodysgensis | Experimental | Procedure: Combined trabeculotomy trabeculectomy with mitomycin Cetiology of primary congenital glaucoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- infants under age of 2 years
- 1ery glaucoma
Key exclusion criteria (3 listed)
- infants more than 2 years
- 2ery glaucoma
- previous glaucoma surgery
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 |
|---|---|---|
| Combined trabeculotomy trabeculectomy with mitomycin CCombined trabeculotomy trabeculectomy with mitomycin C with histopathological examination of the peripheral iris tissue specimen of all cases | Procedure or surgery | isolated trabeculodysgensis |
Primary outcome
fibrovascular membrane over iris surface
Time frame: 6 month
angle closure by a fibrovascular tissue proliferation over the trabecular meshwork in the anterior chamber angle.
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 9 Jul 2019.
- 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?
A study testing Combined trabeculotomy trabeculectomy with mitomycin C in people with Iris Disease, 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 2 inclusion and 3 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 9 Jul 2019. 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?
fibrovascular membrane over iris surface (time frame: 6 month). 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 9 Jul 2019.