NCT07105072

Brief Summary

Presumed trematode-induced granulomatous intermediate uveitis (PTIGIU) presents with vitritis and complicated cataract (active stage) which, if left untreated, progresses to tractional retinal detachment (TRD) from the vitreoretinal traction (cicatricial stage) and eventually cilliary body shut down and atrophia bulbi Accordingly, timely diagnosis of such patients during the active stage is essential for early proper management to avoid complications that might eventually result in blindness. Many treatment modalities for the treatment of AC granulomas were reported, including various combinations of topical corticosteroids, systemic antiparasitic treatment, peribulbar anterior subtenon steroids injections and surgical granuloma excision. Resistant cases may be treated with oral prednisone starting at a daily dose of 1 mg/kg which is gradually tapered over 3-6 weeks . Therefore, many cases may develop steroid-related complications such as cataracts and glaucoma. This study aims at comparing 6-month visual outcomes and complications after vitrectomy versus suprachoroidal triamcinolone acetonide (SCTA) injection in patient presented with cilliary body granuloma in Presumed trematode-induced granulomatous intermediate uveitis (PTIGIU).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 29, 2025

Last Update Submit

July 29, 2025

Conditions

Trematode Induced Granulomatous Uveitis

Keywords

Trematode-Uveitis-Steroid-Vitrectomy

Outcome Measures

Primary Outcomes (2)

  • Size

    Size of ciliary body granuloma by UBM

    From enrollment to the end of treatment at 6 months

  • Size of ciliary body granuloma

    Using Ultrasound biomicroscopy for measuring ciliary body granuloma

    six months follow up

Study Arms (2)

Vitrectomy arm

ACTIVE COMPARATOR

Pars Plana vitrectomy and debulking of ciliary body granuloma

Procedure: Vitrectomy

Suprachoroidal steroid injection

ACTIVE COMPARATOR

Suprachoroida steroid injection of triamcinolone acetonide for ciliary body granuloma.

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE

vtrectomy is a surgical procedure to remove vitreous humor and can be used in case of viritis and as a debulking procedure for ciliary body granuloma.

Suprachoroidal steroid injectionVitrectomy arm

Eligibility Criteria

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

You may qualify if:

  • Children with history of fresh canal water exposure prior to the onset of uveitis.
  • Intermediate uveitis with CB granuloma detected by ultrasound biomicroscopy (UBM).
  • Absence of clinical signs or work-up suggestive of any other cause of granulomatous intermediate uveitis.
  • Failure of medical treatment was defined as persistent or recurrent anterior (flare and cells \>+1) and/or posterior segment inflammation (\>Grade I vitritis) following oral steroids for 8-12 weeks as reported in previous literature.

You may not qualify if:

  • Co-existing ocular pathology that could influence the final visual acuity (VA).
  • known cause of granulomatous uveitis other than trematodal such as(Tuberculosis, sarcoidosis, Syphilis, toxoplasmosis, toxocariasis, Juvenile idiopathic arthritis)
  • Evidence of ocular trauma
  • previous ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Minia university

Minya, 2422998, Egypt

Location

Related Publications (1)

  • Amin RH, Abdullatif AM. Management of presumed trematode-induced granulomatous intermediate uveitis. Eye (Lond). 2023 Aug;37(11):2299-2304. doi: 10.1038/s41433-022-02336-4. Epub 2022 Dec 7.

    PMID: 36477731RESULT

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Lecturer

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

January 20, 2025

Primary Completion

June 20, 2025

Study Completion

July 25, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07

Locations

EG(1)