IrisNCT05484050
VEGF in Iris Tissue in Primary Congenital Glaucoma
A study testing Immunohistochemistry analysis in people with Iris, run by Hassan Lotfy Fahmy at 1 site in Egypt.
Trial summary
Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Iris
- What is being tested?
- Immunohistochemistry analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2022to Jun 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 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- primary congenital glaucoma
Who cannot join
- Infants with history of previous surgery.
- Secondary glaucoma.
- Glaucoma associated with other congenital anomalies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Hassan Lotfy
Asyut, 7111
Hassan Lotfy, prof., 01020833002, hassaniron57@yahoo.com
About this study
Official title: Estimation of Vascular Endothelial Growth Factor (VEGF) in Iris Tissue in Primary Congenital Glaucoma
Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.
Read the detailed description
Combined trabeculotomy with mitomycin C will done in infants with primary congenital glaucoma with histopathological examination of the the peripheral iris tissue specimen and vascular endothelial growth factor (VEGF) estimation in iris tissue specimen through Immunohistochemistry.
Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen taking from ocular trauma or congenital cataract used as control.
- Conditions
- Iris
- Being tested
- Immunohistochemistry analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry analysisOther
Estimation of VEGF through Immunohistochemistry
| Study group | Role | What they receive |
|---|---|---|
| VEGF in iris tissue in primary congenital glaucoma | Other | Estimation of VEGF grade in iris tissue in primary congenital glaucoma through Immunohistochemistry Receives: Other: Immunohistochemistry analysis |
| VEGF in iris tissue from ocular trauma or congenital cataract | Other | Estimation of VEGF grade in iris tissue from ocular trauma or congenital cataract through Immunohistochemistry Receives: Other: Immunohistochemistry analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
VEGF
Estimation of VEGF grade in iris tissue through Immunohistochemistry, The grades is arranged from 0 to 5, with 0 being the lowest level and 5 being the highest level
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 posted2 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IrisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hassan Lotfy Fahmy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hassan Lotfy Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484050
- Sponsor's protocol ID
- 2323300
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 2 Aug 2022
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Vascular Endothelial Growth Factor (VEGF) in Iris Tissue in Primary Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT05484050
- Acronym / sponsor ID
- 2323300
- Conditions
- Iris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hassan Lotfy FahmyUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 2 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.
Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.
Detailed description
Combined trabeculotomy with mitomycin C will done in infants with primary congenital glaucoma with histopathological examination of the the peripheral iris tissue specimen and vascular endothelial growth factor (VEGF) estimation in iris tissue specimen through Immunohistochemistry.
Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen taking from ocular trauma or congenital cataract used as control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEGF in iris tissue in primary congenital glaucoma | Other | Other: Immunohistochemistry analysisEstimation of VEGF grade in iris tissue in primary congenital glaucoma through Immunohistochemistry |
| VEGF in iris tissue from ocular trauma or congenital cataract | Other | Other: Immunohistochemistry analysisEstimation of VEGF grade in iris tissue from ocular trauma or congenital cataract through Immunohistochemistry |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- primary congenital glaucoma
Key exclusion criteria (3 listed)
- Infants with history of previous surgery.
- Secondary glaucoma.
- Glaucoma associated with other congenital anomalies.
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 |
|---|---|---|
| Immunohistochemistry analysisEstimation of VEGF through Immunohistochemistry | Other | VEGF in iris tissue from ocular trauma or congenital cataract, VEGF in iris tissue in primary congenital glaucoma |
Primary outcome
VEGF
Time frame: 6 month
Estimation of VEGF grade in iris tissue through Immunohistochemistry, The grades is arranged from 0 to 5, with 0 being the lowest level and 5 being the highest level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunohistochemistry analysis in people with Iris, run by Hassan Lotfy Fahmy at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VEGF (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 2 Aug 2022.