Different Treatment Approaches of Presumed Trematode-Induced Uveitis

NCT06260449 | Active Not Recruiting DMC

• 1 other identifier: Trematode
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Different Treatment Approaches of Presumed Trematode-Induced Uveitis including periocular injection and medical treatment Nd laser treatment

Conditions

Uveitis

Keywords

Trematode; Pearl shape granuloma

Outcome Measures

Primary Outcomes (1)

• Surgical removal

  Surgical wash of granuloma with topical and systemic steroid

  Baseline

Study Arms (3)

Surgical removal

EXPERIMENTAL

Surgical removal of the whitish granuloma

Procedure: Surgical removal

Medical treatment

NO INTERVENTION

Topical and systemic steroid

Laser treatment

EXPERIMENTAL

Argon laser

Procedure: Surgical removal

Interventions

Surgical removal PROCEDURE

Removal of the granuloma

Laser treatment; Surgical removal

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical Presentation:
• Presence of Uveitis: Include patients with clinically diagnosed uveitis, characterized by inflammation of the uvea9.
• Suspicion of Trematode Etiology: Include cases where there is a reasonable suspicion or evidence suggesting trematode-induced uveitis based on clinical picture of pearl like whitish AC or subconjunctival nodules characteristic for this specific entity, history of swimming in local ponds and canals in endemic areas.10
• Diagnostic Confirmation:
• Severity of Uveitis:
• Disease scores at presentation for parasitic granulomatous uveitis Parameter range score Diameter of AC lesion \>3mm 1 3-5mm 2 \<5mm 3 Grade of AC inflammation +.5 to+1 1
• to +3 2
• Complications at presentation none 0 Retro corneal scar or corectopia 1 Cataract 2 Glaucomatous optic atrophy 3
• Eyes with scores \> 5 were started on steroid therapy. Patients with severity scores \<= 5at presentation were advised for surgical excision of the AC lesions.
• Based on SUN grading scheme for AC cells.
• Age and Gender:
• All Ages: Consider including patients of all age groups. Both Genders: Include both males and females

You may not qualify if:

• Alternative Diagnoses:
• Presence of Other Ocular Diseases: Exclude patients with other causes of uveitis12.
• Concomitant Systemic Infections: Exclude patients with concomitant systemic infections that may independently cause uveitis.
• Patients unwilling to participate in the study
• Treatment History:
• Previous Treatment for Trematode-Induced Uveitis: Exclude patients who have previously undergone treatment specifically for trematode-induced uveitis13.
• Non-Compliance: Exclude patients with a history of non-compliance with prescribed treatments.
• Contraindications to Specific Treatments:
• Contraindications to Medications: Exclude patients with known contraindications to specific antiparasitic medications or corticosteroids.
• Ineligibility for Surgery: Exclude patients who are not suitable candidates for surgical interventions14.
• Pregnancy and Lactation:
• Pregnant or Lactating Women: Consider excluding pregnant or lactating women due to potential risks associated with certain treatments15

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut

Asyut, Egypt

Location

Related Publications (3)

• 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: 36477731 BACKGROUND

• El Hefny E, Sabry D, Sewelam A, El Nokrashy A. Characteristics of Childhood Presumed Trematode-Induced Granulomatous Anterior Uveitis Using Ultrasound Biomicroscopy. Ocul Immunol Inflamm. 2022 Oct-Nov;30(7-8):1604-1608. doi: 10.1080/09273948.2021.1922709. Epub 2021 May 20.

  PMID: 34014799 BACKGROUND

• Amin RM, Radwan AE, Goweida MB, El Goweini HF, Bedda AM, Lotfy WM, Ahmed ARH. Management of presumed trematode induced granulomatous uveitis in pediatric patients. Jpn J Ophthalmol. 2019 Jan;63(1):119-125. doi: 10.1007/s10384-018-0632-3. Epub 2018 Nov 2.

  PMID: 30386949 BACKGROUND

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Single group tested by intervention and medical treatment

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: October 21, 2023
• Primary Completion: October 21, 2024
• Study Completion: December 21, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)