Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response

Uveitis Clinical Trial

— ACID LTR  

Official title:

Impact of Lifestyle and Treatment on the Recurrency and Severity of Acute and Chronic Inflamatory Eye Diseases: Protocol on Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04193020
• Other study ID #: ST-859
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2021
• Source: Wroclaw Medical University
• Contact: Joanna Przezdziecka-Dolyk, PhD
• Phone: +49605693022
• Email: joanna.przezdziecka-dolyk[@]umed.wroc.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Acute and chronic inflammatory eye diseases are difficult to diagnose and maintain quiescent with therapy. Proposed study is aimed to find on the one hand, novel factors for recurrence of the disease or remission of inflammation and evaluation of the impact of lifestyle and known factors on the other.

Each patient is treated in accordance to the best of medical knowledge and guidelines for each disease.

This prospective cohort study will enroll uveitic patients to the steroid only group (SG), combined (steroid and adjuvant drug) group (CG) or bilogic therapy group (BTG).

At baseline, patient data are recorded using patient-reported outcome measures and clinical assessments (ophthalomology) on disease activity (clinical scales), quality of life, and lifestyle together with registry data on comorbidity and medication. During follow-up evaluation of a successful treatment outcome response will be based on clinical scales and most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients in different treatment group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• new diagnosis of uni or bilateral uveitis

• recurrence of the diagnosed previously uni or bilateral uveitis

Exclusion Criteria:

• not mentally able to reply the questionnaire

Related Conditions & MeSH terms

• Uveitis

Intervention

Other:
• Surveillance card
Surveillance card and additional examination to find novel markers and better assess the existing ones

Locations

Country	Name	City	State
Poland	Department of Ophthalmology	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Wroclaw Medical University	Wroclaw University of Science and Technology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	COVID-19 confirmed infection asymptomatic patient	PCR-positive result of COVID-19 specific testing, no treatment required	1 year
Other	COVID-19 confirmed infection	PCR-positive result of COVID-19 specific testing, patient require treatment. The mode of treatment will be recorded into several groups: 1) antibiotics, 2) antivirals, 3) biologic treatment, 4) immunoglobulins, 5) steroids	1 year
Other	COVID-19 related acute respiratory distress syndrome (ARDS)	COVID-19 related acute respiratory distress syndrome (ARDS). Situation in which patients need any of described below: 1) supportive oxygen therapy, 2) non-invasive ventilation, 3) invasive/ mechanical ventilation, 4) use of ECMO, 5) admission to intensive care unit, 6) dialysis	1 year
Other	Ocular Surface Disease Index	Ocular Surface Disease Index (OSDI) questionaire results are used to define if during the course of the disease the dry eye syndrom occurs. Used with subclasses describing the vision-related functions, ocular symptoms, environmental triggers	1 year
Other	Dry Eye Questionnaire	Dry Eye Questionnaire (DEQ 5) questionaire results are used to define if during the course of the disease the dry eye syndrom occurs. Used with subscales describing the eye dyscomfort, eye dryness and watery eyes.	1 year
Other	SANDE Questionnaire	SANDE Questionnaire that assess the frequency and severity of symptoms during the treatment.	1 year
Other	LIKERT Questionnaire	LIKER Questionnaire that assess the frequency, severity of symptoms and infuence of symptoms on the patient day-to-day activities during the treatment.	1 year
Other	LIPCOF scale	Assesment of conjunctival folds according to pre-defined scale.	1 year
Other	OXFORD scale	OXFORD scale conducted with instalation of 2 microliters of 2% fluorescite into the conjunctival sac and assessment according to the pre-defined scale. The subscales for nasal, temporal and lower lid conjunctiva as well as for cornea was used. The scale has been conducted during the treatment period and if necessary during additional visits.	1 year
Other	SICCA scale	SICCA scale conducted with instalation of 2 microliters of 2% fluorescite into the conjunctival sac and assessment of cornea according to the pre-defined scale. Different dye was used for conjunctica (lizamine green). The subscales for nasal and temporal conjunctiva as well as for cornea was used. The scale has been conducted during the treatment period and if necessary during additional visits.	1 year
Primary	Treatment success	Total number of treatment success in each group	1 year
Primary	Recurrence time	Time to the next recurrence after the treatment regimen introduction	10 years
Primary	Severe visual loss	Time and cause of severe visual loss	10 years
Secondary	ETDRS Visual Acuity	Visual Acuity will be performed with ETDRS charts different for right and left eye	10 years
Secondary	The SUN working group grading system for anterior chamber cells	At each visit anterior chamber will be examined to assess anterior chamber cells (1mm x 1mm slit beam in height and width, when thrown at an angle of 45-60°). The recorded number of cells will be used to determine the grade according to the SUN criteria.	10 years
Secondary	The SUN working group grading system for anterior chamber flare	At each visit anterior chamber will be examined to assess anterior chamber flare (1mm x 1mm slit beam in height and width, when thrown at an angle of 45-60°). The observed changes will be used to determine the grade according to the SUN criteria.	10 years
Secondary	AREDS 2008 Clinical Lens Opacity Grading Procedure	Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded.	10 years
Secondary	NIH grading system for vitreous cells	At each visit vitreous will be examined to assess vitreous cells (1mm x 3mm slit beam in anterior vitreous). The recorded number of cells will be used to determine the grade according to the NIH criteria.	10 years
Secondary	NIH grading system for vitreous haze	At each visit vitreous will be examined to assess vitreous haze. The recorded of clarity of posterior pole funduscopy will be used to determine the grade according to the NIH criteria.	10 years
Secondary	Submacular choroidal thickness	OCT EDI recordings processed with developed by researchers methodology for image processing.	10 years