Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response (ACID LTR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Uveitis
• Intervention / Treatment: Other: Surveillance card

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Joanna Przeździecka-Dołyk, PhD; Phone Number: +49605693022; Email: joanna.przezdziecka-dolyk@umed.wroc.pl

Study Locations

• Poland
  • Wrocław, Poland, 54-622
    • Recruiting
    • Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
steroid only group (SG)	Other: Surveillance card; Surveillance card and additional examination to find novel markers and better assess the existing ones
combined (steroid and adjuvant drug) group (CG)	Other: Surveillance card; Surveillance card and additional examination to find novel markers and better assess the existing ones
bilogic therapy group (BTG)	Other: Surveillance card; Surveillance card and additional examination to find novel markers and better assess the existing ones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success	Total number of treatment success in each group	1 year
Recurrence time	Time to the next recurrence after the treatment regimen introduction	10 years
Severe visual loss	Time and cause of severe visual loss	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ETDRS Visual Acuity	Visual Acuity will be performed with ETDRS charts different for right and left eye	10 years
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
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
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
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
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
Submacular choroidal thickness	OCT EDI recordings processed with developed by researchers methodology for image processing.	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 confirmed infection asymptomatic patient	PCR-positive result of COVID-19 specific testing, no treatment required	1 year
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
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
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
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
SANDE Questionnaire	SANDE Questionnaire that assess the frequency and severity of symptoms during the treatment.	1 year
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
LIPCOF scale	Assesment of conjunctival folds according to pre-defined scale.	1 year
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
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

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Collaborators: Wrocław University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: December 7, 2019
• First Submitted That Met QC Criteria: December 7, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: ST-859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Sharing coded data such as BCVA, intraocular preassure, visual functioning questionaire responses, anterior chamber cells and flare scales records as well as lens opacity grading records.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No