NCT07885137

Brief Summary

Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Sep 2026Dec 2027

Study Start

First participant enrolled

September 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

October 7, 2026

Last Update Submit

October 15, 2026

Conditions

Keywords

PTIGU- granulomatous Uveitis

Outcome Measures

Primary Outcomes (2)

  • Testing samples by PCR for DNA Detection

    detect trematodal DNA in the ocular fluid of presumed trematode-induced uveitis by using PCR

    6 month

  • Organism detection

    identify the organism responsible for trematode-induced uveitis through DNA sequence analysis of genetic material extracted from ocular fluid.

    6 month

Study Arms (2)

Anterior Uveitis

Anterior Chamber granuloma AC Wash AC fluid Sample

Genetic: AC fluid sample

Intermediate / posterior Uveitis

Ciliary body granuloma PPV and Viteous fluid sample

Genetic: Vitreous fluid sample

Interventions

PCR using trematoda specific primers DNA sequencing

Anterior Uveitis

PCR using trematoda specific primer DNA sequencing

Intermediate / posterior Uveitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • Patients with Presumed Trematode-Induced Uveitis scheduled for AC wash or pars plana vitrectomy of any age.

You may not qualify if:

  • Causes of granulomatous uveitis other than trematodal infection.
  • Inconclusive UBM findings.
  • Ocular trauma.
  • Previous ocular surgeries including (anterior chamber wash for AC granulomas).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Cairo University Kasr Al Ainy Hospital

Cairo, Giza Governorate, 11956, Egypt

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Aqueous fluid Vitreous Fluid

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Central Study Contacts

Amnah A Amin, Master degree ophthalmology

CONTACT

Abdussalam M Abdullatif, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Ophthalmology Cairo University

Study Record Dates

First Submitted

October 7, 2026

First Posted

October 21, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

IPD will be shared upon request

Locations