UveitisNCT06260449
Different Treatment Approaches of Presumed Trematode-Induced Uveitis
A study testing Surgical removal in people with Uveitis, run by Assiut University at 1 site in Egypt.
Trial summary
Different Treatment Approaches of Presumed Trematode-Induced Uveitis including periocular injection and medical treatment Nd laser treatment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uveitis
- What is being tested?
- Surgical removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2023to 21 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- Positive Diagnostic Findings: Include patients with characteristic clinical picture and exclusion of other causes of granulomatous uveitis by appropriate laboratory tests and imaging modalities.11
- Severity of Uveitis:
Show all 13Show fewer
- 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
- 2 to +3 2
- 4 3 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Different Treatment Approaches of Presumed Trematode-Induced Uveitis including periocular injection and medical treatment Nd laser treatment
Read the detailed description
Uveitis, characterized by inflammation of the uvea, is a complex and potentially sight-threatening ocular condition that can result from various etiologies. Among causes of uveitis, trematode-induced uveitis represents a distinct and intriguing subset characterized by the presence of a single or multiple pearl like nodules in the anterior chamber (AC) or less commonly in the conjunctive, cornea or even in the ciliary body and posterior segment. Trematodes, or parasitic flatworms, have been implicated in causing uveitis through the migration of larvae or adult worms into the eye, triggering an inflammatory response 1. Despite its rarity, trematode-induced uveitis poses diagnostic and therapeutic challenges due to the diversity of trematode species and the lack of standardized treatment protocols 2. The treatment of trematode-induced uveitis typically involves addressing the underlying parasitic infection and managing the associated inflammation. Various treatment modalities have been reported in literature. Antiparasitic medications have been tried by some authors. Advantages include targeting the underlying cause by killing the parasites. In addition, systemic medications can reach distant sites of infection However, there is no evidence that the parasite is actually living in ocular tissues and the inflammatory process may be directed against already dead parasite 3. Also, they may have side effects. Effectiveness depends on the specific type of trematode and its susceptibility to the chosen medication. Steroid Therapy is considered the gold standard treatment including topical steroids and periocular Injection of Triamcinolone) Advantages: Reduces inflammation in the eye. Provides symptomatic relief. Disadvantages: Does not address the underlying cause (parasitic infection)4. Prolonged or high-dose steroid use may lead to side effects, such as increased intraocular pressure or cataract formation. In resistant cases Surgery has been advocated by many authors Advantages: Surgical removal of nodules may be considered in specific cases. Can be beneficial in cases of severe complications, such as retinal detachment5. Disadvantages: Invasive procedure with associated risks and is mainly aimed at managing complications.
Laser Therapy has been reported to destroy the pearl like nodules using Argon laser Potential damage to surrounding healthy tissue is the main drawback.
Therefore, there is no consensus about the best line of treatment for this entity Rational for this study: Understanding the available treatment options is crucial for healthcare professionals involved in the care of patients with this condition7
- Conditions
- Uveitis
- Being tested
- Surgical removal
- Keywords
- Trematode, Pearl shape granuloma
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical removalProcedure or surgery
Removal of the granuloma
| Study group | Role | What they receive |
|---|---|---|
| Surgical removal | Experimental | Surgical removal of the whitish granuloma Receives: Procedure: Surgical removal |
| Medical treatment | No intervention | Topical and systemic steroid |
| Laser treatment | Experimental | Argon laser Receives: Procedure: Surgical removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical removal
Surgical wash of granuloma with topical and systemic steroid
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start21 Oct 2023
- Primary completion21 Oct 2024 (estimated)
- Study completion21 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single group tested by intervention and medical treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260449
- Sponsor's protocol ID
- Trematode
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36477731El 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.
PubMed 34014799Amin 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.
PubMed 30386949
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Treatment Approaches of Presumed Trematode-Induced Uveitis
- ClinicalTrials.gov ID
- NCT06260449
- Acronym / sponsor ID
- Trematode
- Conditions
- Uveitis
- Keywords
- Trematode, Pearl shape granuloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Oct 2023 (actual)
- Primary completion
- 21 Oct 2024 (estimated)
- Study completion
- 21 Dec 2024 (estimated)
- First posted
- 15 Feb 2024 (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.
Different Treatment Approaches of Presumed Trematode-Induced Uveitis including periocular injection and medical treatment Nd laser treatment
Detailed description
Uveitis, characterized by inflammation of the uvea, is a complex and potentially sight-threatening ocular condition that can result from various etiologies. Among causes of uveitis, trematode-induced uveitis represents a distinct and intriguing subset characterized by the presence of a single or multiple pearl like nodules in the anterior chamber (AC) or less commonly in the conjunctive, cornea or even in the ciliary body and posterior segment. Trematodes, or parasitic flatworms, have been implicated in causing uveitis through the migration of larvae or adult worms into the eye, triggering an inflammatory response 1. Despite its rarity, trematode-induced uveitis poses diagnostic and therapeutic challenges due to the diversity of trematode species and the lack of standardized treatment protocols 2. The treatment of trematode-induced uveitis typically involves addressing the underlying parasitic infection and managing the associated inflammation. Various treatment modalities have been reported in literature. Antiparasitic medications have been tried by some authors. Advantages include targeting the underlying cause by killing the parasites. In addition, systemic medications can reach distant sites of infection However, there is no evidence that the parasite is actually living in ocular tissues and the inflammatory process may be directed against already dead parasite 3. Also, they may have side effects. Effectiveness depends on the specific type of trematode and its susceptibility to the chosen medication. Steroid Therapy is considered the gold standard treatment including topical steroids and periocular Injection of Triamcinolone) Advantages: Reduces inflammation in the eye. Provides symptomatic relief. Disadvantages: Does not address the underlying cause (parasitic infection)4. Prolonged or high-dose steroid use may lead to side effects, such as increased intraocular pressure or cataract formation. In resistant cases Surgery has been advocated by many authors Advantages: Surgical removal of nodules may be considered in specific cases. Can be beneficial in cases of severe complications, such as retinal detachment5. Disadvantages: Invasive procedure with associated risks and is mainly aimed at managing complications.
Laser Therapy has been reported to destroy the pearl like nodules using Argon laser Potential damage to surrounding healthy tissue is the main drawback.
Therefore, there is no consensus about the best line of treatment for this entity Rational for this study: Understanding the available treatment options is crucial for healthcare professionals involved in the care of patients with this condition7
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single group tested by intervention and medical treatment
| Arm | Type | Receives |
|---|---|---|
| Surgical removal | Experimental | Procedure: Surgical removalSurgical removal of the whitish granuloma |
| Medical treatment | No intervention | –Topical and systemic steroid |
| Laser treatment | Experimental | Procedure: Surgical removalArgon laser |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Positive Diagnostic Findings: Include patients with characteristic clinical picture and exclusion of other causes of granulomatous uveitis by appropriate laboratory tests and imaging modalities.11
- 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
- 2 to +3 2
Key exclusion criteria (12 listed)
- 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
- 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.
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 |
|---|---|---|
| Surgical removalRemoval of the granuloma | Procedure or surgery | Laser treatment, Surgical removal |
Primary outcome
Surgical removal
Time frame: Baseline
Surgical wash of granuloma with topical and systemic steroid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 36477731Amin 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.
- Background: PubMed 34014799El 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.
- Background: PubMed 30386949Amin 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical removal in people with Uveitis, run by Assiut University 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 13 inclusion and 12 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 15 Feb 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical removal (time frame: Baseline). 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 NCT06260449, which also lists 3 linked publications.
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 15 Feb 2024.