Presumed Trematode Induced UveitisNCT07885137
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
An observational study of Presumed Trematode Induced Uveitis and Uveitis, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Presumed Trematode Induced Uveitis, Uveitis
- What is being tested?
- AC fluid sample and Vitreous fluid sample
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 PTIGU of any age presenting to the Kasr Al-Aini Uveitis and Ocular Immunology Clinic who are scheduled to undergo AC wash or pars plana vitrectomy will be included in the study. The diagnosis of PTIGU will be based on the following criteria:1) history of fresh canal water contact in one of the branches of the River Nile prior to the onset of uveitis, 2) signs of anterior uveitis with the presence of typical AC granuloma 3) signs of intermediate uveitis with the confirmation of CB granuloma by ultrasound biomicroscopy (UBM), 4) absence of clinical signs or work-up suggestive of any other cause of granulomatous Uveitis. 5) Failure of medical treatment by steroids in the form of persistent anterior segment flare and cells >+1 or posterior segment inflammation (> Grade 2 vitritis).
Who may be able to join
- Patients with Presumed Trematode-Induced Uveitis scheduled for AC wash or pars plana vitrectomy of any age.
Who cannot join
- Causes of granulomatous uveitis other than trematodal infection.
- Inconclusive UBM findings.
- Ocular trauma.
- Previous ocular surgeries including (anterior chamber wash for AC granulomas).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abdussalam M Abdullatif, Assistant Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Cairo University Kasr Al Ainy Hospital
Cairo, Giza Governorate, 11956
About this study
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
Read the detailed description
Patients with PTIGU of any age presenting to the Kasr Al-Aini Uveitis and Ocular Immunology Clinic who are scheduled to undergo AC wash or pars plana vitrectomy will be included in the study For all included patients, we will retrieve the age, gender, eye laterality, duration of disease, and the treatment received (topical, regional, and systemic). Careful review of systems and thorough investigations will be done as guided by clinical presentation (to exclude other causes of granulomatous uveitis). These investigations may be in the form of complete blood picture, stool and urine analysis, fluorescent treponemal antibody absorbent test, angiotensin-converting enzyme, tuberculin skin testing, toxocara antibodies, toxoplasma antibodies, and chest X-ray.
All patients will undergo thorough clinical examination including corrected distance visual acuity (CDVA), intraocular pressure (IOP) measurement, and ophthalmic findings with slit-lamp examination will be collected including the AC with associated granulomas, iris status regarding presence of synechiae, gonioscopic findings, lens status and vitreous inflammatory grades according to the Standardized Uveitis Nomenclature (SUN) classification. Dilated fundus examination with slit-lamp biomicroscopy and indirect ophthalmoscopy with scleral indentation will be explored to document the presence of retinal detachment, macula status, and grades of proliferative vitreoretinopathy (PVR). Also, B scan ultrasonography (US) will be done if media opacities precluded fundus examination. Ultrasonographic biomicroscopy (UBM) will be done to determine the presence and location of ciliary body granuloma.
All surgeries will be done under general anesthesia by the same experienced posterior segment surgeon. All eyes will receive topical antibiotics with topical prednisolone acetate 1% eye drops given every 2 hours for the first 48 hours followed by 5 times daily to be tapered according to AC reaction in addition to antibiotic combined with steroid ointment at bedtime.
Samples will be stored in sterile Epindorf tubes at -80°C. DNA will be extracted from the samples using DNeasy tissue kit (Qiagen, Hilden, Germany) according to manufacturer's.
A primer pair, CO1F (5-GATCGTA AATTTGGATACTGC-3) and CO1R (5-CCAACCATAAACATATGATG-3) targeting trematodal mitochondrial cytochrome c oxidase subunit 1 (CO1) gene will be used. PCR will be made in 25 µL reaction containing 12.5 µL MyTaq HS red Master Mix (Bioline, England), 0.5 µM of each primer and 0.5 µL DNA extract. PCR conditions will include initial denaturation at 95°C for 4 min followed by 35 cycles of denaturation at 95°C for 15 s, annealing at 54°C for 15 s and extension at 72°C for 30 s. PCR products will then be examined on 1.5% agarose gel stained with ethidium bromide to detect the expected 250 bp amplified product. In samples undergoing sequencing, the amplified products will be loaded on the gel and purified using the DNA Purification Kit (Promega, Madison, WI, USA). The cyclic sequencing reaction will be performed. Samples will be denatured at 96°C for 2 min and then cycled 28 times at 96°C for 10 s, 52°C for 10 s, and 60°C for 4 min. Unincorporated nucleotides will be removed by using sodium carbonate, 125 mmol/L EDTA, and absolute alcohol. HI-Di Formamide (Applied Biosystems) will be used to stabilize the single-strand template before preforming sequencing. Sequences will be analyzed by using BLAST for species-level identification.
- Conditions
- Presumed Trematode Induced Uveitis, Uveitis
- Being tested
- AC fluid sample, Vitreous fluid sample
- Keywords
- PTIGU- granulomatous Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC fluid sampleGenetic
PCR using trematoda specific primers DNA sequencing
Vitreous fluid sampleGenetic
PCR using trematoda specific primer DNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| Anterior Uveitis | Anterior Chamber granuloma AC Wash AC fluid Sample Receives: Genetic: AC fluid sample | |
| Intermediate / posterior Uveitis | Ciliary body granuloma PPV and Viteous fluid sample Receives: Genetic: Vitreous fluid sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing samples by PCR for DNA Detection
detect trematodal DNA in the ocular fluid of presumed trematode-induced uveitis by using PCR
Measured: 6 month
Organism detection
identify the organism responsible for trematode-induced uveitis through DNA sequence analysis of genetic material extracted from ocular fluid.
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 posted21 Oct 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Presumed Trematode Induced UveitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amnah Ayman, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885137
- Sponsor's protocol ID
- MD-276-2026
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared upon request
Publications
1. El Nokrashy, A., Abou Samra, W., Sobeih, D. et al. Treatment of presumed trematode-induced granulomatous anterior uveitis among children in rural areas of Egypt. Eye 33, 1525-1533 (2019). 2. Rathinam SR, Usha KR, Rao NA. Presumed trematode-induced granulomatous anterior uveitis: a newly recognized cause of intraocular inflammation in children from south India. Am J Ophthalmol. 2002 Jun;133(6):773-9. 3. Rathinam S, Fritsche TR, Srinivasan M, Vijayalakshmi P, Read RW, Gautom R, et al. An outbreak of trematode-induced granulomas of the conjunctiva. Ophthalmology. 2001;108(7):1223-9. 4. Amin RM, Goweida MB, El Goweini HF, Bedda AM, Lotfy WM, Gaballah AH, et al. Trematodal granulomatous uveitis in paediatric Egyptian patients: A case series. Br J Ophthalmol. 2017;101(8):999-1002. 5. Amin RH, Abdullatif AM. Management of presumed trematode-induced granulomatous intermediate uveitis. Eye. 2023;37(11):2299-304. 6. Amin RM, Goweida M, Bedda A, Kamel A, Radwan A. Clinical patterns and causes of intraocular inflammation in a uveitis patient cohort from Egypt. Ocul Immunol Inflamm. 2016;26:1-9 7. Arya LK, Rathinam SR, Lalitha P, Kim UR, Ghatani S, Tandon V. Trematode fluke Procerovum varium as cause of ocular inflammation in children, South India. Emerg Infect Dis. 2016;22(2):192-200. 8. Rathinam SR, Arya LK, Usha KR, Prajna L, Tandon V. Novel etiological agent: molecular evidence for trematode-induced anterior uveitis in children. Arch Ophthalmol. 2012;130:1481-4. 9. Amin RM, Radwan AE, Goweida MB, El Goweini HF, Bedda AM, Lotfy WM, et al. Management of presumed trematode induced granulomatous uveitis in pediatric patients. Jpn J Ophthalmol. 2019;63(1):119-25. 10. El Nokrashy A, Abou Samra W, Sobeih D, Lamin A, Hashish A, Tarshouby S, et al. Treatment of presumed trematode-induced granulomatous anterior uveitis among children in rural areas of Egypt. Eye. 2019;33(10):1525-33.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
- ClinicalTrials.gov ID
- NCT07885137
- Acronym / sponsor ID
- MD-276-2026
- Conditions
- Presumed Trematode Induced Uveitis, Uveitis
- Keywords
- PTIGU- granulomatous Uveitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
Detailed description
Patients with PTIGU of any age presenting to the Kasr Al-Aini Uveitis and Ocular Immunology Clinic who are scheduled to undergo AC wash or pars plana vitrectomy will be included in the study For all included patients, we will retrieve the age, gender, eye laterality, duration of disease, and the treatment received (topical, regional, and systemic). Careful review of systems and thorough investigations will be done as guided by clinical presentation (to exclude other causes of granulomatous uveitis). These investigations may be in the form of complete blood picture, stool and urine analysis, fluorescent treponemal antibody absorbent test, angiotensin-converting enzyme, tuberculin skin testing, toxocara antibodies, toxoplasma antibodies, and chest X-ray.
All patients will undergo thorough clinical examination including corrected distance visual acuity (CDVA), intraocular pressure (IOP) measurement, and ophthalmic findings with slit-lamp examination will be collected including the AC with associated granulomas, iris status regarding presence of synechiae, gonioscopic findings, lens status and vitreous inflammatory grades according to the Standardized Uveitis Nomenclature (SUN) classification. Dilated fundus examination with slit-lamp biomicroscopy and indirect ophthalmoscopy with scleral indentation will be explored to document the presence of retinal detachment, macula status, and grades of proliferative vitreoretinopathy (PVR). Also, B scan ultrasonography (US) will be done if media opacities precluded fundus examination. Ultrasonographic biomicroscopy (UBM) will be done to determine the presence and location of ciliary body granuloma.
All surgeries will be done under general anesthesia by the same experienced posterior segment surgeon. All eyes will receive topical antibiotics with topical prednisolone acetate 1% eye drops given every 2 hours for the first 48 hours followed by 5 times daily to be tapered according to AC reaction in addition to antibiotic combined with steroid ointment at bedtime.
Samples will be stored in sterile Epindorf tubes at -80°C. DNA will be extracted from the samples using DNeasy tissue kit (Qiagen, Hilden, Germany) according to manufacturer's.
A primer pair, CO1F (5-GATCGTA AATTTGGATACTGC-3) and CO1R (5-CCAACCATAAACATATGATG-3) targeting trematodal mitochondrial cytochrome c oxidase subunit 1 (CO1) gene will be used. PCR will be made in 25 µL reaction containing 12.5 µL MyTaq HS red Master Mix (Bioline, England), 0.5 µM of each primer and 0.5 µL DNA extract. PCR conditions will include initial denaturation at 95°C for 4 min followed by 35 cycles of denaturation at 95°C for 15 s, annealing at 54°C for 15 s and extension at 72°C for 30 s. PCR products will then be examined on 1.5% agarose gel stained with ethidium bromide to detect the expected 250 bp amplified product. In samples undergoing sequencing, the amplified products will be loaded on the gel and purified using the DNA Purification Kit (Promega, Madison, WI, USA). The cyclic sequencing reaction will be performed. Samples will be denatured at 96°C for 2 min and then cycled 28 times at 96°C for 10 s, 52°C for 10 s, and 60°C for 4 min. Unincorporated nucleotides will be removed by using sodium carbonate, 125 mmol/L EDTA, and absolute alcohol. HI-Di Formamide (Applied Biosystems) will be used to stabilize the single-strand template before preforming sequencing. Sequences will be analyzed by using BLAST for species-level identification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Uveitis | – | Genetic: AC fluid sampleAnterior Chamber granuloma AC Wash AC fluid Sample |
| Intermediate / posterior Uveitis | – | Genetic: Vitreous fluid sampleCiliary body granuloma PPV and Viteous fluid sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with PTIGU of any age presenting to the Kasr Al-Aini Uveitis and Ocular Immunology Clinic who are scheduled to undergo AC wash or pars plana vitrectomy will be included in the study. The diagnosis of PTIGU will be based on the following criteria:1) history of fresh canal water contact in one of the branches of the River Nile prior to the onset of uveitis, 2) signs of anterior uveitis with the presence of typical AC granuloma 3) signs of intermediate uveitis with the confirmation of CB granuloma by ultrasound biomicroscopy (UBM), 4) absence of clinical signs or work-up suggestive of any other cause of granulomatous Uveitis. 5) Failure of medical treatment by steroids in the form of persistent anterior segment flare and cells >+1 or posterior segment inflammation (> Grade 2 vitritis).
Key inclusion criteria (1 listed)
- Patients with Presumed Trematode-Induced Uveitis scheduled for AC wash or pars plana vitrectomy of any age.
Key exclusion criteria (4 listed)
- Causes of granulomatous uveitis other than trematodal infection.
- Inconclusive UBM findings.
- Ocular trauma.
- Previous ocular surgeries including (anterior chamber wash for AC granulomas).
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 |
|---|---|---|
| AC fluid samplePCR using trematoda specific primers DNA sequencing | Genetic | Anterior Uveitis |
| Vitreous fluid samplePCR using trematoda specific primer DNA sequencing | Genetic | Intermediate / posterior Uveitis |
Primary outcome
Testing samples by PCR for DNA Detection
Time frame: 6 month
detect trematodal DNA in the ocular fluid of presumed trematode-induced uveitis by using PCR
Organism detection
Time frame: 6 month
identify the organism responsible for trematode-induced uveitis through DNA sequence analysis of genetic material extracted from ocular fluid.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background1. El Nokrashy, A., Abou Samra, W., Sobeih, D. et al. Treatment of presumed trematode-induced granulomatous anterior uveitis among children in rural areas of Egypt. Eye 33, 1525-1533 (2019). 2. Rathinam SR, Usha KR, Rao NA. Presumed trematode-induced granulomatous anterior uveitis: a newly recognized cause of intraocular inflammation in children from south India. Am J Ophthalmol. 2002 Jun;133(6):773-9. 3. Rathinam S, Fritsche TR, Srinivasan M, Vijayalakshmi P, Read RW, Gautom R, et al. An outbreak of trematode-induced granulomas of the conjunctiva. Ophthalmology. 2001;108(7):1223-9. 4. Amin RM, Goweida MB, El Goweini HF, Bedda AM, Lotfy WM, Gaballah AH, et al. Trematodal granulomatous uveitis in paediatric Egyptian patients: A case series. Br J Ophthalmol. 2017;101(8):999-1002. 5. Amin RH, Abdullatif AM. Management of presumed trematode-induced granulomatous intermediate uveitis. Eye. 2023;37(11):2299-304. 6. Amin RM, Goweida M, Bedda A, Kamel A, Radwan A. Clinical patterns and causes of intraocular inflammation in a uveitis patient cohort from Egypt. Ocul Immunol Inflamm. 2016;26:1-9 7. Arya LK, Rathinam SR, Lalitha P, Kim UR, Ghatani S, Tandon V. Trematode fluke Procerovum varium as cause of ocular inflammation in children, South India. Emerg Infect Dis. 2016;22(2):192-200. 8. Rathinam SR, Arya LK, Usha KR, Prajna L, Tandon V. Novel etiological agent: molecular evidence for trematode-induced anterior uveitis in children. Arch Ophthalmol. 2012;130:1481-4. 9. Amin RM, Radwan AE, Goweida MB, El Goweini HF, Bedda AM, Lotfy WM, et al. Management of presumed trematode induced granulomatous uveitis in pediatric patients. Jpn J Ophthalmol. 2019;63(1):119-25. 10. El Nokrashy A, Abou Samra W, Sobeih D, Lamin A, Hashish A, Tarshouby S, et al. Treatment of presumed trematode-induced granulomatous anterior uveitis among children in rural areas of Egypt. Eye. 2019;33(10):1525-33.
- Individual participant dataSharing planned: No. IPD will be shared upon request
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.
Abdussalam M Abdullatif, Assistant Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presumed Trematode Induced Uveitis and Uveitis, run by Kasr El Aini Hospital 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 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amnah A Amin, Master degree ophthalmology (01006371579 ext. +2, amnah95@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing samples by PCR for DNA Detection (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07885137, which also lists 1 linked publication.
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 21 Oct 2026.